MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 102956

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Right Ventricular Failure (2055)

Event Date 04/02/2019

Event Type  Death  

Manufacturer Narrative

Approximate age of device - 11 days.Device was not explanted from the patient after expiration.It was reported that the device will not be available to be returned to the manufacturer for analysis.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2019.It was reported that the patient remained in the intensive care unit(icu) since the implant.Patient's right side of the heart was showing signs of failure during the implant procedure.Post-operation the patient's right side continued to show signs of failure.An impella was placed on the right side and removed.Then a centrimag was placed on the right side in an attempt to improve the right side of the heart.None of these actions were able to help.Patient expired on (b)(6) 2019 due to right side heart failure.The hm 3 operated as expected.Death is not due to the hm 3.The hm 3 will not be returned and an autopsy will not be performed.Additional information as of (b)(6) 2019: cause of death was cardiogenic shock, acute on chronic systolic heart failure and severe rv dysfunction.Hm3 operated as expected.No further information provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between the centrimag blood pump and the reported event could not conclusively be established through this evaluation.Centrimag blood pump ifu lists death as an adverse event that may be associated with the use on the centrimag vad.The centrimag blood pump ifu lists death as an adverse event that may be associated with the use on the centrimag vad.

• Brand Name: CENTRIMAG MOTOR, US
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• MDR Report Key: 8559511
• MDR Text Key: 143368840
• Report Number: 2916596-2019-02126
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 102956
• Device Catalogue Number: 102956
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/02/2019
• Initial Date FDA Received: 04/27/2019
• Supplement Dates Manufacturer Received: 07/16/2019; 02/10/2020
• Supplement Dates FDA Received: 07/22/2019; 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 33 YR
• Patient Weight: 119