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 Problems Dyspnea (1816); Fatigue (1849); Liver Damage/Dysfunction (1954); Renal Impairment (4499)

Event Date 04/29/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the reported events, as well as a direct correlation to heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(4), could not conclusively be determined through this evaluation.The controller event and periodic log files collectively contained data from (b)(6) 2021 through (b)(6) 2022, per the timestamps.No notable pump-related events were captured, and the pump appeared to function as intended at the set speed.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.The patient remains ongoing on hm3 lvas, serial number (b)(4), and no further events have been reported at this time.The heartmate 3 lvas ifu, rev.C, is currently available.Section 1 of the ifu, ¿introduction¿, lists potential adverse events, including multiple types of organ failure and dysfunction (respiratory failure, right heart failure, renal failure, and hepatic dysfunction), that may be associated with the use of the heartmate 3 left ventricular assist system.The relevant sections of the device history records for (b)(4) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 21-apr-2021.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient was seen in the clinic on (b)(6) 2022 with ongoing fatigue, dyspnea, bloating, and elevated n-terminal (nt)-pro hormone bnp (nt-probnp).Worsening renal insufficiency and hepatic dysfunction were also noted.Ventricular assist device (vad) interrogations had been benign and no alarms were noted.Log file review captured multiple pulsatility index (pi) events with no other unusual events observed.It was planned to perform a right heart catheterization (rhc) and ramp testing.

• 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 14468878
• MDR Text Key: 292356548
• Report Number: 2916596-2022-10783
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/04/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7908013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2021
• 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): Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 85 KG