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

Model Number	105581US
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Event or Problem Description
It was reported that during implant pump preparation, the operating room nurse observed outflow graft 8928557 from implant kit (b)(6) had a visible fold at the end of the bend relief.The surgeon was concerned this would impinge on the function of the outflow graft so they used outflow graft 8408593 from implant kit (b)(6) to replace outflow graft 8928557.It was observed that outflow graft 8408593 also had a very slight fold at the end of the bend relief, however it was still implanted with pump (b)(6).There were no patient consequences.Related manufacturer reference number: 2916596-2023-07287 - outflow graft 8408593.
Additional Manufacturer Narrative
Manufacturer¿s investigation conclusion: the reported event was confirmed through the evaluation of the returned outflow graft bend relief, lot number 8928557, and review of the submitted photos.The outflow graft and outflow graft bend relief were returned in like-new condition.Visual inspection of the distal end of the outflow graft bend relief revealed a loose/folded outer ptfe (polytetrafluoroethylene) layer.The hardware of the outflow graft and outflow graft bend relief were inspected, and no abnormalities were observed.A manufacturing assessment (ma) task was initiated to address deformation of the outflow graft bend relief observed during implant.The outer layer of the outflow graft bend relief is applied by abbott¿s supplier, and the evaluation performed by the supplier identified no root cause.It was suspected that the issue was not detected during inspection/verification as required in the supplier's corresponding procedures.An ecar was issued to the supplier for notification of the observed issue.An update to the receiving inspection and manufacturing procedures was initiated to provide clarity to the written inspection criteria.The heartmate 3 lvas instructions for use (ifu) provides instructions for unpacking and preparing the sealed outflow graft.The ifu warns 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.Relevant sections of the device history records for the outflow graft, lot number 8928557 and bend relief, lot number 8826981 were reviewed and showed no deviations from the manufacturing and qa (quality assurance) specifications.There were no ncmrs (non-conformance material report) or re-works related to the reported event.No further information was provided.The manufacturer is closing the file on this event.
Additional Manufacturer Narrative
Section d1 brand name: corrected.Section d4 catalog number: corrected.Section d4 primary udi number: corrected.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC® HEARTMATE 3¿
• Common Device Name: VENTRICULAR (ASSIST) DEVICE
• 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 ; 7818528204
• MDR Report Key: 18013816
• Report Number: 2916596-2023-07286
• Device Sequence Number: 7548668
• Product Code: DSQ
• UDI-Device Identifier: 00813024013266
• UDI-Public: (01)00813024013266(10)8928557(17)250518
• 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,Followup
• Report Date (Section B): 05/24/2024

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: Health Professional
• Device Expiration Date: 05/18/2025
• Device Model Number: 105581US
• Device Catalogue Number: 105581US
• Device Lot Number: 8928557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/04/2023
• Supplement Date Received by Manufacturer: 02/26/2024; Not provided
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 02/28/2024; 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2022
• 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: 54 YR
• Patient Sex: Male
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White