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

Model Number 106524INT

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

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 01/02/2021

Event Type  Injury  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported that the patient underwent a transplant for unknown reasons.No additional information was provided.

Event Description

It was reported that the transplant was routine.

Manufacturer Narrative

Manufacturer's investigation conclusion: no specific pump-related issues or adverse events were reported.The patient was reportedly transplanted on (b)(6) 2021 after being designated as bridge to transplant (btt).It was reported via the patient outcome that the patient underwent a transplant on (b)(6) 2021.There were no alarms associated with this event.Privacy laws prohibit the customer from providing information regarding the case; however, it was later reported that the patient was bridge to transplant (btt).The account indicated that although the patient¿s pump, heartmate 3 left ventricular assist system (lvas) , serial number (b)(6), was explanted, it would 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.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) and heartmate 3 lvas patient handbook are currently available.No specific device-related issues or adverse events were reported; however, the heartmate 3 lvas ifu provides a list of adverse events that may be associated with the use of the heartmate 3 left ventricular assist system in section 1, ¿introduction¿.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11132829
• MDR Text Key: 225574726
• Report Number: 2916596-2021-00069
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2021
• Device Model Number: 106524INT
• Device Lot Number: 6516258
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention