MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; Ventricular (assist) bypass

Model Number 106524US

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

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 03/31/2024

Event Type  Injury  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

Event Description

It was reported through the patient outcome that the patient received a heart transplant.The patient was not elevated on the transplant due to a device or therapy related issue.The patient had right sided heart failure.It was noted that the transplant was not routine.The device operated as expected.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6), and the reported events could not be conclusively established through this evaluation.It was communicated that the device will not be returned for evaluation.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.Although the event was not considered to be device related, the heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) rev.C lists potential adverse events that may be associated with the use of the heartmate 3 lvas.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was additionally reported that the patient had pre-existing right sided heart failure.The right heart failure was due to natural progression of the disease.The right heart failure was not device related.The right ventricle was dilated and severely hypokinetic.The heart failure resolved when the patient was transplanted.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: Ventricular (assist) 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 19154309
• MDR Text Key: 340802006
• Report Number: 2916596-2024-02092
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: (01)00813024013297(10)10143310(17)250919
• 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: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 106524US
• Device Lot Number: 10143310
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/05/2024
• 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): Hospitalization; Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American