MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE 3¿; 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	02/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Event or Problem Description
It was reported that the surgeon manipulated the outflow graft bend relief with scalpel and 5.0 aortic punch due to concerns for extrinsic outflow graft obstruction (eogo).After creating one of the holes using the 5.0 punch, the bend relief in the area of the punch fractured.The surgeon was unsure if they accidently hit one of the plastic rings.The outflow graft was replaced with the outflow graft from the backup kit.The surgeon requested analysis to confirm the cause of the fractured bend relief.The fractured bend relief and outflow graft were to be returned to abbott.There were no adverse patient effects as a result of the reported event.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: evaluation of the returned sealed outflow graft assembly confirmed the reported damage.A photograph submitted for review showed the outflow graft and the bend relief.The bend relief had two fenestrations.The bend relief also had a tear/cut that extended along the beading.Examination of the returned confirmed the bend relief was fenestrated approximately 1" and 2" from the bend relief hardware.A tear/cut was observed ~3" from the bend relief hardware that extended along the beading (figure 1).The tear/cut appeared to extend along at least 50% of the bend relief circumference (figure 1).It was reported that this damage occurred while the user was attempting to fenestrate the bend relief using a 5.0 aortic punch.Review of the available device history records for lot number 9160512 showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu), rev.C, is currently available.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.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: 18690786
• Report Number: 2916596-2024-00854
• Device Sequence Number: 8424456
• Product Code: DSQ
• UDI-Device Identifier: 00813024013266
• UDI-Public: (01)00813024013266(10)9062601(17)250822
• 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
• Device Implanted Year: 2024
• 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): 10/29/2024

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: 08/22/2025
• Device Model Number: 105581US
• Device Catalogue Number: 105581US
• Device Lot Number: 9062601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2024
• 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: 02/01/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2022
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 72 KG