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 Low Blood Pressure/ Hypotension (1914); Shock (2072); Hypovolemia (2243); Confusion/ Disorientation (2553)

Event Date 04/22/2022

Event Type  Injury  

Event Description

It was reported noted that the patient experienced vasodilatory shock on (b)(6) 2022, but it resolved on its own.

Manufacturer Narrative

No additional informaiton has been provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

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 cannot be conclusively determined through this evaluation.The patient was discharged home on an unspecified date and remains ongoing on heartmate 3 lvas, serial number (b)(6).The relevant sections of the device history records were reviewed and showed no deviation from manufacturing or quality assurance specifications.The heartmate 3 lvas instructions for use (ifu) lists other neurological events (not stroke-related) as adverse events, as well as potential late postimplant complications, that may be associated with the use of the heartmate 3 left ventricular assist system.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient presented to an outside hospital (osh) with hypotension and vasodilatory shock.The patient's fluid were resuscitated.The vasodilatory shock reportedly resolved and was believed to have been caused by extra trazodone doses and volume depletion.The patient reportedly took an extra dose of tramadol to help them sleep, which may have contributed to the event, per the account.

• 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: 14399983
• MDR Text Key: 291714748
• Report Number: 2916596-2022-10983
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/27/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8325426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2022
• 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; Hospitalization
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White