MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE 3¿; VENTRICULAR (ASSIST) BYPASS

Model Number	105581US
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during pump prep, it was noticed that the outflow graft bend relief had lifting of the material at the distal end of the graft.Bend relief was not used as protocol for this center, but the site wanted to report what was seen.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Additional Manufacturer Narrative
Section h6 correction: health effect - impact code 4656 - problem identified before clinical use/exposure added.Manufacturer's investigation conclusion: evaluation of the returned heartmate 3 outflow graft bend relief confirmed the reported event.The outflow graft bend relief was returned in like-new condition.The outflow graft was not returned.Visual inspection of the distal end of the outflow graft bend relief revealed a folded outer ptfe (polytetrafluoroethylene) layer.The remainder of the bend relief appeared unremarkable.The hardware of the outflow graft bend relief was inspected, and no abnormalities were observed.A manufacturing task was previously initiated to address delamination of the outflow graft bend relief.The outer layer of the outflow graft bend relief is applied by abbott¿s supplier.A supplier corrective action was previously issued to the supplier for the observed issue.Additionally, manufacturing and receiving inspection procedures were updated to provide clarity to the written inspection criteria.It should be noted that the outflow graft bend relief under this event was manufactured and inspected prior to completion of these actions.Relevant sections of the device history records for the outflow graft, lot number 10363892 and bend relief, lot number 10171556 were reviewed and showed no deviations from manufacturing quality assurance specifications.There were no ncmrs (non-conformance material report) or re-works related to the reported event.The current revision of the instructions for use (ifu) can be found on the eifu page of the abbott website.The heartmate 3 left ventricular assist system (lvas) ifu, rev.D, is currently available.Chapter 5, "surgical procedures", contains instructions for unpacking and preparing the sealed outflow graft and bend relief.This chapter also states that states that during the implant process, a complete backup system (implant kit and external components) must be available on-site and in close proximity for use in an emergency.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC® HEARTMATE 3¿
• Common Device Name: 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: 20858389
• Report Number: 2916596-2024-07712
• Device Sequence Number: 3864413
• Product Code: DSQ
• UDI-Device Identifier: 00813024013266
• UDI-Public: (01)00813024013266(10)10363892(17)260727
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/27/2026
• Device Model Number: 105581US
• Device Catalogue Number: 105581US
• Device Lot Number: 10363892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2024
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 115 KG