MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 SEALED OUTFLOW GRAFT WITH BEND RELIEF; VENTRICULAR (ASSIST) BYPASS

Model Number	105581US
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2022
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 completed.
Event or Problem Description
It was reported that while the outflow graft was being prepped for implant, fraying was noticed at the connector.A new outflow graft was used for implant.
Additional Manufacturer Narrative
Manufacture¿s investigation conclusion: evaluation of the returned outflow graft, as well as evaluation of the submitted image, confirmed the loose/fraying threading of the outflow graft.It was reported that while the outflow graft was being prepped for implant, fraying was noticed at the connector.A new outflow graft was used for implant.The outflow graft and outflow graft bend relief were returned in like-new condition.Visual inspection of the proximal end of the outflow graft revealed loose threads/fraying near the graft attachment.The outflow graft bend relief outer layer material appeared unremarkable.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 fraying of the outflow graft material out of box (oob).An awareness training to the quality assurance procedure was performed to address this issue.Additionally, the procedure was updated to include additional pictures from the complaint to further specify the rejection criteria for unacceptable loose or fraying threads on the outflow graft.No further action was required.Review of the available device history records for lot number 8288086 showed no deviations from manufacturing or qa (quality assurance) specifications.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) rev.C is currently available.Section 5 of this ifu contains instructions for unpacking the sealed outflow graft (5-15) 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: 15953293
• Report Number: 2916596-2022-15633
• Device Sequence Number: 7427240
• Product Code: DSQ
• UDI-Device Identifier: 00813024013266
• UDI-Public: 00813024013266
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 04/17/2023

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: Lay User/Patient
• Device Expiration Date: 04/15/2024
• Device Model Number: 105581US
• Device Catalogue Number: 105581US
• Device Lot Number: 8288086
• 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: 12/05/2022
• Supplement Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 12/09/2022
• Supplement Report FDA Received Date: 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2021
• 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: 42 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American