MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSISST) BYPASS

Model Number 106524US

Device Problems Device Difficult to Setup or Prepare (1487); Malposition of Device (2616); Material Twisted/Bent (2981); No Apparent Adverse Event (3189)

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/02/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient was admitted to the hospital with decompensated heart failure on (b)(6) 2021 and presented to the or (operating room) on (b)(6) 2021 for implant of hm3 (heartmate 3) by a left lateral thoracotomy approach during the index procedure.Prior to going to the or, patient was placed on an intra-aortic balloon pump (iabp) and hm3 was implanted.The transesophageal echocardiogram (tee) noted large amounts of air coming from left ventricle (lv) apex area.Multiple attempts were made to address the bleeding concern and adjust the pump, but there was no resolution to air in the lv.The large amount of air was a concern that the pump was not properly locked and/or possibly damaged.A sterile mini cuff was opened and tested and a small (~1 cm) portion of the locking mechanism was visible on the pump.This exposure was noted before and locking mechanism was not completely flush on left side.(hm3 (b)(4)) was replaced with hm3 (b)(4).Once the second hm3 pump was attached to the initial apical cuff, there was no additional air in the left ventricle.The patient was weaned off bypass, the air appeared to improve as seen on tee.The right ventricle was not doing well and the patient was placed on fem/ fem v-a ecmo (femoral venoarterial extracorporeal membrane oxygenation) to provide additional hemodynamic support using the hm3 as an lv vent.The chest was left open and the patient returned to the icu (intensive care unit).On (b)(6) 2021 , computed tomography (ct) of the head displayed questionable small infarct in the left anterior frontal lobe of uncertain age.Patient began having seizures likely due to air entrainment of first vad (ventricular assist device).The patient passed away on (b)(6) 2021 due to neurological failure to wake up post operation of heartmate 3 implant.Hm3 (b)(4) death report: mfr# 2916596-2021-05725.

Manufacturer Narrative

Further information was received indicating this event was a duplicate and reported in manufacturer report number 2916596-2021-05332.The investigations findings and codes will be submitted under manufacturer report number 2916596-2021-05332.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSISST) 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 12642594
• MDR Text Key: 276842185
• Report Number: 2916596-2021-05495
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8015441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 66 KG
• Patient Ethnicity: Hispanic
• Patient Race: White