MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE 3¿; VENTRICULAR (ASSIST) BYPASS

Model Number	105581US
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during pump preparation, the outflow graft had 3 threads at the distal end.The distal end of the outflow graft was snipped off and pump preparation continued.The outflow graft tip was passed off the sterile field.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Additional Manufacturer Narrative
Section a1: corrected.Section d1: corrected.Section d4: corrected catalog number and primary udi.Manufacturer's investigation conclusion: evaluation of the returned outflow graft portion, as well as evaluation of the submitted photos, confirmed loose/fraying of the outflow graft.Approximately 1" of the distal end of the outflow graft (stretched out) was returned in like-new condition.Visual inspection of the outflow graft portion revealed loose threads/fraying on the edge.The remainder of the outflow graft was not returned as it was used to proceed with the implant.A manufacturing assessment (ma) task was initiated to address fraying of the outflow graft material out of box (oob).An awareness training to the manufacturing and quality assurance procedures was performed to address this issue.No further action was required.The patient remains ongoing on heartmate 3 left ventricular assist system (lvas) support with no further issues reported at this time.Review of the available device history records for the sealed outflow graft, lot number 9225820 showed no deviations from manufacturing or qa (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 the sealed outflow graft (5-15) and preparing the sealed outflow graft (5-16).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: THORATEC® HEARTMATE 3¿
• 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: 19006356
• Report Number: 2916596-2024-01940
• Device Sequence Number: 18487732
• Product Code: DSQ
• UDI-Device Identifier: 00813024013266
• UDI-Public: (01)00813024013266(10)9225820(17)251118
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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): 06/25/2024

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: 11/18/2025
• Device Model Number: 105581US
• Device Catalogue Number: 105581US
• Device Lot Number: 9225820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2024
• 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: 03/26/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2022
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American