MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE APICAL CORING KNIFE; Ventricular (assist) bypass

Model Number 1050

Device Problems Dull, Blunt (2407); Infusion or Flow Problem (2964)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/03/2024

Event Type  Injury  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Event 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.

• Brand Name: HEARTMATE APICAL CORING KNIFE
• Type of Device: 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
• MDR Text Key: 340563100
• Report Number: 2916596-2024-02140
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/18/2024

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
• Device Operator: Health Professional
• Device Model 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
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 104 KG