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

Model Number	105581US
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the pump prep after the outflow graft was attached, it was noticed that there was leaking at the point of connection where the dacron met the metal.The outflow graft was removed and replaced.The leaking occurred again.Another outflow graft was opened and attached which leaked as well.A third outflow graft was opened and this time it did not leak.Related mfr # 2916596-2023-06113.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Additional Manufacturer Narrative
Manufacturer¿s investigation conclusion: evaluation of the returned outflow graft confirmed the reported leaking.The outflow graft was returned in like-new condition.Visual inspection of the outflow graft revealed the surface of the knitted graft appeared shiny, indicating that gelatin was present in the graft.No holes or damage were observed through visual or microscopic inspection.The outflow graft was plugged, and the lumen was filled with water.The graft held water until the water pressure was directed toward the hardware connection then water began to drip from the spot where the graft material meets the metal, reproducing the leak.The remainder of the graft did not leak.The graft was sent to pleasanton for additional testing.A manufacturing analysis task was initiated to address the out of box leaking of the outflow graft during pump assembly.Root cause analysis found that the most probable root cause of the leaking graft was related to the stitching method at the supplier.An external corrective action was issued to the supplier.The relevant sections of the device history records for the outflow graft, lot # 8755250, were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 lvas instructions for use (ifu) rev.C is currently available.Section 5 of this ifu contains instructions for unpacking 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
• 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: 17654858
• Report Number: 2916596-2023-06114
• Device Sequence Number: 17987110
• Product Code: DSQ
• UDI-Device Identifier: 00813024013266
• UDI-Public: 00813024013266
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2024

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: 04/07/2025
• Device Model Number: 105581US
• Device Lot Number: 8755250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2023
• 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: 08/11/2023
• Supplement Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2022
• 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 Sex: Unknown