MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSISST) BYPASS

Model Number 106524US

Device Problems Obstruction of Flow (2423); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Renal Failure (2041); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446)

Event Date 10/29/2021

Event Type  Death  

Event Description

It was reported that the patient was transferred from one healthcare facility to another on right sided impella.The patient crashed shortly after admission on (b)(6) 2021.The patient was placed on venoarterial extracorporeal membrane oxygenation (va ecmo) and their impella was removed shortly after.The patient had been on ecmo and continuous dialysis since (b)(6) 2021.The left ventricular assist device (lvad) had been in a constant low flow state.Log file review captured persistent low flow events with the calculated flow routinely in the 1 liter per minute (lpm) range.There was suspicion of pump thrombosis.It was communicated on (b)(6) 20221 that the patient passed away on (b)(6) 2021 due to right ventricular failure.The pump was not returned for analysis.

Manufacturer Narrative

Patient transferred from christiana care health system to temple no further information was provided.An additional report will be submitted once the manufacturer's investigation is complete.

Event Description

Additional information was received on (b)(6) 2021 that right heart failure existed prior to lvad implantation and the device did not contribute.However, renal failure did not exist prior to device implantation.It was also communicated that there were no changes to patient condition, anticoagulation status, or pump parameters that would have contributed to pump thrombosis.Diagnostic testing results were unable to be provided.The device operated as expected and the patient's death was not considered to be device related.Additional information was received on (b)(6) 2022 that the low flow alarms were attributed to right ventricular failure and presumed outflow graft obstruction.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 12920005
• MDR Text Key: 281645954
• Report Number: 2916596-2021-06777
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/22/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8101235
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/02/2021
• Initial Date FDA Received: 12/02/2021
• Supplement Dates Manufacturer Received: 01/17/2022
• Supplement Dates FDA Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Death; Hospitalization
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 101 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American