MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 SEALED OUTFLOW GRAFT WITH BEND RELIEF; 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	12/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No additional information has been provided.A supplemental report will be submitted once the manufacturer's investigation is complete.
Event or Problem Description
It was reported that the surgeon removed the outflow graft from the heartmate 3 left ventricular assist system (lvas) implant kit during procedure.The package was sterile at the time of opening; however, on inspection of the polytetrafluoroethylene (ptfe) packaging it was found that the wrapping was loose prior to opening.The surgeon did not feel comfortable using the product and requested to use a new outflow graft from off the shelf.
Event or Problem Description
Additional information reported that there were no adverse consequences to the patient and the issue did not cause a significant delay in the procedure.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: evaluation of the returned outflow graft confirmed the reported loose outer layer on the outflow graft bend relief.The outflow graft and outflow graft bend relief were returned in like-new condition.Visual inspection of the proximal end of the outflow graft bend relief revealed loose ptfe (polytetrafluoroethylene) wrapping near the hardware of the outflow graft.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 loose material on the outer layer of the outflow graft bend relief found out of box.The outer layer of the outflow graft bend relief is applied by abbott¿s supplier.A non-issuance corrective action was issued to the supplier for notification of the observed issue.No further action was required.Review of the relevant sections of the device history records for lot number 8278236 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.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 5 of this ifu contains instructions for unpacking the sealed outflow graft and preparing the sealed outflow graft (5-16).Section 5 also 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: HEARTMATE 3 SEALED OUTFLOW GRAFT WITH BEND RELIEF
• 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 16061529
• Report Number: 2916596-2022-16117
• Device Sequence Number: 20493073
• Product Code: DSQ
• UDI-Device Identifier: 00813024013266
• UDI-Public: 00813024013266
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2023

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: 04/13/2024
• Device Model Number: 105581US
• Device Catalogue Number: 105581US
• Device Lot Number: 8278236
• 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: 12/21/2022
• Supplement Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2021
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 106 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White