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	04/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the metal ring on the outflow graft bend relief lacerated the outflow graft while the surgeon attempted to connect the two.The surgeon repaired the outflow graft with suture and chose not to use the bend relief.It was later reported that the patient was alive and progressing to inpatient rehab.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of the metal ring on the outflow graft bend relief lacerating the outflow graft while the surgeon attempted to connect the two could not be confirmed through this investigation as no photos were provided by the account and no product was returned for evaluation.The patient remains ongoing on heartmate 3 lvas (left ventricular assist system), serial number, (b)(6).No further events have been reported at this time.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu), rev.C, provides information regarding how to prepare the sealed outflow graft for implant and includes steps for attaching the outflow graft to the pump.The ifu warns that failure to connect the bend relief so that it is fully and evenly connected can allow kinking and abrasion of the graft, which may lead to serious adverse events such as low left ventricular assist device flow and/or bleeding.The ifu also instructs the user to visually inspect the bend relief to confirm that it is fully connected and seated to the sealed outflow graft.To confirm, try to unseat the connected bend relief from the metal fitting by gently pulling the bend relief back toward the anastomosis and then towards the pump.The bend relief should remain captured and move approximately 0.5 mm without disengaging from the graft.The relevant sections of the device history record for the outflow graft assembly, lot number 8621596, was reviewed and showed no deviations from manufacturing or quality assurance specifications.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: 16897453
• Report Number: 2916596-2023-02449
• Device Sequence Number: 5956550
• Product Code: DSQ
• UDI-Device Identifier: 00813024013266
• UDI-Public: 00813024013266
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 07/23/2023

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: 08/27/2024
• Device Model Number: 105581US
• Device Catalogue Number: 105581US
• Device Lot Number: 8621596
• 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: 04/17/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2021
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 100 KG