MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE® XVE AND HEARTMATE II®, APICAL CORING KNIFE; VENTRICULAR (ASSIST) BYPASS

Model Number	1050
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a: patient information not yet available.Section d4: device serial number was not provided, so the expiration date and manufacture date (h4) cannot be determined.The primary udi number in d4 is reflective of all available information.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that during implant, the apical coring knife was dull and difficult to core the left ventricle.
Event or Problem Description
Details provided on 17sep2025 stated that the coring procedure was able to be completed.
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 coring knife, serial number (b)(6), could not confirm the reported event of dullness and difficulty coring.A specific cause for the reported event could not be conclusively determined through this evaluation.The coring knife was returned loose in a plastic jar along with the knife handle.The protective caps were not returned.Residue consistent with blood was present on the knife body and blade edge.The knife otherwise appeared unremarkable upon visual inspection.Microscopic inspection did not reveal any evidence of damage or defect.A cut test was performed with the returned coring knife and a polyurethane sheet.The knife was able to cut through this material without issue, comparable to a control knife.Review of the coring knife manufacturing documentation found no deviations from manufacturing or quality specifications.These inspections include a cut test and visual inspection of the knife edge under magnification.The knife passed all testing and inspection.A corrective action/preventive action (capa) investigation was opened to further investigate issues related to the coring knife not being able to cut.The relevant sections of the device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.The current revision of the instructions for use (ifu) can be found on the eifu page of the abbott website.The heartmate 3 left ventricular assist system (lvas) ifu, rev.D, is currently available.Chapter 1, "introduction", lists the apical coring knife as an optional component for device implantation.Chapter 5, ¿surgical procedures¿, provides information on preparing and handling the coring knife.This chapter 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® XVE AND HEARTMATE II®, APICAL CORING KNIFE
• 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: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 23116299
• Report Number: 2916596-2025-06093
• Device Sequence Number: 7741976
• Product Code: DSQ
• UDI-Device Identifier: 00813024010227
• UDI-Public: (01)00813024010227(17)280324
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup
• Report Date (Section B): 02/20/2026

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 Model Number: 1050
• Device Catalogue Number: 1050
• Device Lot Number: L00003165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2025
• 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: 09/11/2025
• Supplement Date Received by Manufacturer: 09/17/2025; 02/19/2026
• Initial Report FDA Received Date: 09/22/2025
• Supplement Report FDA Received Date: 10/08/2025; 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2025
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 51 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White