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

Model Number	105581US
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufactures investigation conclusion: evaluation of the returned outflow graft assembly, lot number 7683225, confirmed the reported flecks in the lumen of the outflow graft.The sealed outflow graft and outflow graft bend relief were returned in like-new condition.Both the outflow graft and outflow graft bend relief were free of distortion.Examination of the interior surface of the sealed outflow graft revealed 2 flecks both situated approximately 2.5 inches from the outflow graft hardware.The flecks were removable with tweezers.The debris appeared to be a piece of the pre-clot gelatin.The interior surfaces of the sealed outflow graft and graft attachment were otherwise unremarkable.The bend relief material was unremarkable.The screw ring revealed no evidence of damage or defects to the screw threads.The outflow ptfe washer was present and properly seated within the screw ring.The graft attachment o-ring and c-ring were both free of damage and located in the correct grooves within the graft attachment.Outflow graft, lot number 7683225, was shipped to the supplier for further analysis.Per the supplier¿s investigation, the excess gelatin particulate was likely introduced to the graft after the impregnation process, as the supplier¿s final inspection did not identify gelatin specs prior to release.The cause of the gelatin particles being present could not be conclusively determined at this time.Additionally, abbott performed a voluntary review of internal procedures.The relevant manufacturing and inspection procedures will be updated to include inspection for excess gelatin specks.Abbott will continue to monitor this issue.The heartmate 3 lvas ifu, rev.C is currently available.The ifu outlines the steps for preparing a heartmate 3 sealed outflow graft for implantation, including ¿inspect the interior of the graft and remove any debris¿.The ifu also warns that a complete backup system must be available on-site and in close proximity for use in an emergency.The relevant sections of the device history records for the outflow graft assembly, lot number 7683225 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 during pump preparation the implanting surgeon noticed a small fleck in the outflow graft.The site decided not to use it as it was reported as ¿out of box failure.¿.

• Brand Name: HEARTMATE 3 SEALED OUTFLOW GRAFT WITH BEND RELIEF
• Common Device Name: VENTRICULAR (ASSISST) 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: 13497814
• Report Number: 2916596-2022-00836
• Device Sequence Number: 11790539
• Product Code: DSQ
• UDI-Device Identifier: 00813024013266
• UDI-Public: 00813024013266
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/09/2022

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: 01/13/2023
• Device Model Number: 105581US
• Device Catalogue Number: 105581US
• Device Lot Number: 7683225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• 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: 02/08/2022
• Initial Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2020
• 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