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

Model Number	105581INT
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
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 the implant center normally fenestrated the outflow graft the during preparation of the outflow graft.When they attempted to make the holes in the bend relief, the outflow graft split.The outflow graft was discarded, and a new one was used.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: review of the submitted image provided by the account confirmed the reported tear/split in the midline of the outflow graft bend relief.The patient remains ongoing on heartmate lvas (left ventricular assist system), serial number (b)(6), and no further events have been reported at this time.Review of the available device history records for lot number 10172528 showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 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.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, INT
• 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: 19607776
• Report Number: 2916596-2024-03798
• Device Sequence Number: 6359648
• Product Code: DSQ
• UDI-Device Identifier: 00813024010616
• UDI-Public: (01)00813024010616
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/30/2025
• Device Model Number: 105581INT
• Device Catalogue Number: 105581INT
• Device Lot Number: 10172528
• Was Device Available for Evaluation?: No
• 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: 06/03/2024
• Supplement Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 07/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2022
• 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: 21 YR
• Patient Sex: Male
• Patient Weight: 79 KG