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

Model Number	1050
Medical Device Problem Codes	Dull, Blunt (2407); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/03/2024
Type of Reportable Event	Serious Injury
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 during the pump-off part of the implant on (b)(6) 2024, which was done via the thoracotomy approach with use of a foley with balloon inflation of 7 mls for tension, along with the heartmate apical coring knife.The surgeon noted that the coring did not feel different than expected and a round part of the left ventricle was removed before the pump was inserted.Shortly after starting the pump at 12:20 pm, flows decreased with low flow alarms despite an increase in pump speed.Flows then dropped to 0.9 lpm with pump power at 3.3 w and speed at 6000 rpm.An echocardiogram showed no flow through the pump.The patient was put on cardiopulmonary bypass (cpb) at 12:53 pm and the pump was turned off at 12:54 pm.The pump was unlocked and removed, and upon inspection of the left ventricle the surgeon noted that the coring knife had not completely cut through the left ventricular apex.The remaining portion of the apex was obstructing the inflow cannula, resulting in lower flows.The remaining portion of the left ventricle was removed with a scalpel and the pump was again placed into the apical cuff and locked in place.The pump was turned on and pump speed was increased with stable flows throughout the remainder of the case.It was noted that extended silence remained on and time in the operating room (or) had been extended due to the patient requiring cpb, with likely an increase in blood loss, but the patient was ultimately stable.
Additional Manufacturer Narrative
Section d1 - brand name: corrected.Section d4 - catalog number: corrected.Section d4 - primary unique device identification (udi) number: corrected.Manufacturer's investigation conclusion: the evaluation of the returned coring knife, serial number (b)(6), did not confirm a device-related issue that would have contributed to the reported event.The coring knife, serial number (b)(6), was returned in used condition with the plastic plug and cap.The handle was not returned.Visual inspection of the knife edge under magnification found an area where the blade appeared to have impacted another hard surface, resulting in a void and rollover of the edge.The majority of the cutting edge appeared unremarkable.The returned coring knife passed cut testing and felt comparable to the same cut test performed with a test knife.The observed damage on the returned knife did result in added tactile feedback during the cut but no additional force or rotation of the knife was required to complete the cut.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.Coring knife, serial number 140930, passed all testing and inspection.The evaluation could not conclusively determine if the knife edge became damaged prior to or after use, however, the damage did not appear to impact the function of the coring knife.The cause of the reported event could not be conclusively determined.The relevant sections of the device history records were reviewed and 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 1, "introduction," lists the apical coring knife as an optional component for device implantation.Section 5, ¿surgical procedures,¿ provides information on preparing and handling the coring knife.This section 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 19137850
• Report Number: 2916596-2024-02140
• Device Sequence Number: 9437835
• Product Code: DSQ
• UDI-Device Identifier: 00813024010227
• UDI-Public: (01)00813024010227(17)251118
• 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): 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): 08/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/18/2025
• Device Model Number: 1050
• Device Catalogue Number: 1050
• Device Lot Number: 10126331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2024
• 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: 04/03/2024
• Supplement Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 104 KG