31
CentriMag System Component
No. of Events
Bleeding
1
Total
30
Total Number of MDRs
285
The blood leak events listed in Table 14 associated with the cannula were related to failure of the solvent bond between the body of the
cannula and the integral connector that was used to join the cannulas to the circuit tubing. The designs of the arterial and venous
cannula were changed in 2015 to use a separate barbed connector to join the cannulas to the circuit tubing.
The motor cable break events listed in Table 14 were the subject of a field action initiated by the applicant in 2018. All previously
reported complaints with this failure mode were reanalyzed for reportability, resulting in an increase in reportable events related to
motor cable break failure. Labeling updates and a cable redesign were initiated and have been approved for commercial distribution.
The CentriMag system was the subject of a field action initiated in August 2019 involving reports of motor and pump issues resulting in
system/alarm(s)/faults from electromagnetic interference (EMI). Root cause was determined to be associated with the calibration of the
motors manufactured from August 8, 2017 to July 22, 2019. The production test tool software was fixed. All affected CentriMag
motors are to be returned to an Abbott Medical facility for inspection and recalibration and subsequently returned to the customer. A
replacement unit will be provided as appropriate.
The overall MDR rate (number of MDR’s/number of pumps distributed)
observed for the CentriMag Circulatory Support System is
consistent with those documented in the published literature for other short-term mechanical circulatory support devices.
Effectiveness Results
The primary analysis to assess effectiveness was based on the 32 evaluable Pivotal FTW Study patients at the 30-day post-device
removal time point. The primary study endpoint of survival at 30 days post device removal or to hospital discharge in the pivotal trial
for failure to wean from cardiopulmonary bypass (FTW from CPB) was 63%, far exceeding the typical rate reported in the literature of
27%. Key effectiveness outcomes are presented in the tables below.
Table 15. CentriMag Effectiveness in FTW Subjects from CPB Pivotal Study (G030052/S21) – Survival and Primary Endpoint
Clinical Study
N
Survival to
30 Days
Post-device
Survival
To
Discharge
Primary
Endpoint
Success
FTW from CPB
Pivotal Trial
(G030052/S21)
32
22/32
(69%)
20/32
(63%)
20/32
(63%)
The outcomes summarized in the table above were a function of use of the CentriMag system for durations that range from a minimum
of 1 day and up to a maximum duration of 90 days. The duration of support observed for the Pivotal Study is summarized below in the
table below.
Table 16. Duration of CentriMag Support in FTW Subjects from CPB Pivotal Study (G030052/S21)
Clinical Study
Indication For Use
N
Mean
Duration
Of Support
(days)
Range
(days)
FTW from CPB
Pivotal Trial
(IDE G030052)
FTW
32
12.7
1 - 90
Improvements in hemodynamics were evaluated as a secondary endpoint in the pivotal study for failure to wean from cardiopulmonary
bypass. As shown in the table below, MAP increased and CVP decreased during support with the CentriMag system during the pivotal
study for FTW from CPB, based on a comparison of paired values. No paired data points were available for analysis of Left Atrial
Pressure or Cardiac Index because, given the hemodynamic instability of the patient population at baseline, data for these parameters
were collected only at the discretion of the investigator.
Table 17. Hemodynamics - FTW from CPB Pivotal Study (G030052/S21)
Hemodynamic Parameter
Paired
Values
(n)
Baseline
Mean Value
During CentriMag System
Support
CVP
5
19.2 mmHg
13.7 mmHg
MAP
23
67.6 mmHg
75.3 mmHg
Key indicators of end organ function (blood urea nitrogen, creatinine and bilirubin) were tracked during the Pivotal FTW Study of the
CentriMag system. Mean blood chemistry values during the first 14 days of support with the device during the pivotal study of failure
to wean from cardiopulmonary bypass show decreasing trends for BUN and creatinine but increasing levels of bilirubin (Table 18).
Table 18. End Organ Function – FTW from CPB Pivotal Study (G030052/S21)
Interval
N
Mean
Range
Blood Urea Nitrogen
Baseline
32
39
12 – 94
21
Success: Survival to 30 days post-device removal or to hospital discharge, whichever is longer; or survival to induction to anesthesia for surgery for cardiac transplantation or
conversion to other long-term mechanical circulatory support system.
