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

Model Number 106524US

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

Patient Problems Renal Failure (2041); Right Ventricular Dysfunction (2054)

Event Date 09/09/2020

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 due to right ventricle dysfunction, while in or (operating room) post implant, an rvad (rotoflow device) was inserted to provide right ventricle support.Patient also required continuous veno-venous hemofiltration (cvvh) support for kidney function.

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the reported events, as well as a direct correlation to heartmate 3 lvas, serial number: (b)(6), could not conclusively be determined.It was reported that the patient was implanted with an rvad due to right ventricle dysfunction post implant.Additionally, the patient was placed on continuous veno-venous hemofiltration (cvvh) support for kidney function.Multiple attempts to gather additional information was attempted; however, none was provided.The patient remains ongoing on heartmate 3 lvas, serial number: (b)(6).No product is available for investigation.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The pump was shipped on (b)(6) 2020.The heartmate 3 lvas ifu lists renal dysfunction and right heart failure as adverse events that may be associated with the use of heartmate 3 left ventricular assist system.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: 10777632
• MDR Text Key: 214316972
• Report Number: 2916596-2020-05274
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7577654
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 28 YR
• Patient Weight: 98