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	04/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is no patient involvement; therefore, patient information is not pertinent to the investigation.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 bend relief came apart during the prep phase before it was placed in the patient.A new bend relief and outflow graft was obtained for the implant.
Additional Manufacturer Narrative
Manufacture¿s investigation conclusion: the reported event was confirmed through evaluation of the submitted image.Evaluation of the provided image revealed an incomplete cross-sectional cut in the midsection of the bend relief material.The cut appeared clean and most likely had been induced by a sharp tool.In addition, a hole was observed in between the reinforcement beads of the bend relief, approximately 1" from the bend relief hardware.These observations appeared consistent with the report of the surgeon voluntarily making modifications to the outflow graft bend relief.No indication of a device malfunction was observed nor reported through the provided information.The damaged outflow graft assembly was discarded, and a new outflow graft and bend relief were obtained to proceed with implant.No product was returned for evaluation.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1 of this ifu contains description of the outflow graft assembly and warns that the outflow graft bend relief is not to be cut.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.Additionally, this section notes that only the vascular graft is intended to be cut or clamped, not the outflow graft bend relief.Do not trim or cut the bend relief of the sealed outflow graft or a sharp edge may result.This sharp edge could damage the underlying graft material and cause blood loss.The relevant sections of the device history records for the outflow graft assembly, lot number 8517903 were 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.
Event or Problem Description
It was reported that the surgeon had punch a hole in the bend relief during pump preparation and the bend relief came apart during the prep phase before it was placed in the patient.The surgeon wanted to cut a small slit and use a punch between the ribs.

• 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: 16746972
• Report Number: 2916596-2023-02207
• Device Sequence Number: 8556425
• Product Code: DSQ
• UDI-Device Identifier: 00813024013266
• UDI-Public: 00813024013266
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/23/2023

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: Lay User/Patient
• Device Expiration Date: 08/23/2024
• Device Model Number: 105581US
• Device Catalogue Number: 105581US
• Device Lot Number: 8517903
• 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: 04/12/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2021
• 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 Sex: Unknown