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); Gas/Air Leak (2946); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Heart Failure/Congestive Heart Failure (4446)

Event Date 09/02/2021

Event Type  Injury  

Manufacturer Narrative

The patient's initials were not provided.No further information was provided.A supplemental report will be submitted when 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 operating room on (b)(6) 2021 for implant of heartmate 3 by a left lateral thoracotomy approach.Prior to coming to the operating room he was placed on an intra-aortic balloon pump (iabp).The heartmate 3 was implanted and it was noted on the transesophageal echocardiogram (tee) that there were large amounts of air that was coming from the left ventricle (lv) apex area.Multiple attempts were made to address if a bleeding concern and adjust the pump with no resolution of the air in the lv.The large amount of air were a concern that the pump was not properly locked and/or possibly damaged.A sterile mini cuff was opened and tested to see if could properly lock and again it was noted that a very small (~1 cm) portion of the locking mechanism was visible on the left side (10/11 o¿clock) of the pump and there was no yellow visual.This was the same that was noticed before.A decision was made while in the operating room and not able to get off by-pass to exchange the pump.Then the second heartmate 3 pump attached to the initial apical cuff with no additional air in the left ventricle.Once the second pump was weaned off by pass it appeared to correct the air entrapment that was seen on tee.Unfortunately the right ventricle was not doing well and the patient was placed on fem/ fem venoarterial extracorporeal membrane oxygenation (va-ecmo) to provide additional hemodynamic support.The chest was left open and the patient returned to the icu.On (b)(6) 2021 the chest was washed out and closed but remained on va-ecmo.It has been reported 09sep2021 that the patient has responded to pain only and not following commands and has continued to have seizures.Patient remained hemodynamically stable and there were no concerns with the operation of the heartmate 3.Since patient was unable to wean off va ecmo.Multiple family meetings occurred with the healthcare team and a decision to withdrawal support was made on (b)(6) 2021.No autopsy was performed, and the pump was not explanted.Related manufacturer report number of second pump and death: 2916596-2021-05766.

Manufacturer Narrative

The information regarding (b)(6) 2021 ct scan results was originally reported in related manufacturer report numbers: 2916596-2021-05495 and 2916596-2021-05725.Manufacturer's investigation conclusion: the evaluation of heartmate 3 left ventricular assist system (lvas), serial number (b)(4), confirmed damage to the locking arms of the cuff lock.The damage to the cuff lock would have caused the yellow indicators to be visible when the cuff lock was in the fully locked position.Additionally, a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(4), and the report of a questionable small infarct in the left anterior frontal lobe could not conclusively be established through this evaluation.The pump was returned assembled with the cuff lock in the fully locked position with a mini apical cuff secured with the cuff lock.Prior to removal, the mini apical cuff was articulated and rotated within the lock and the connection did not feel loose.It was noted that the yellow indicators were slightly visible while the cuff lock was in the fully locked position.Upon removal of the mini apical cuff, one of the cuff lock locking arms appeared bent.The cuff lock moved freely upon manipulation and could not be forced into the locked position with no mini apical cuff in place, as intended by design.The o-ring that seals the interface between the inflow cannula and the mini apical cuff was present and appeared free of damage or defect.Measurements were taken of the cuff lock and confirmed that both locking arms were bent out of specification.Review of manufacturing documentation, which includes functional testing and visual inspection of the cuff lock for bent arms, found no deviations in manufacturing or quality assurance specifications.The cuff lock assembly was reassembled and the returned mini apical cuff was connected.The cuff lock engaged easily without issue.The yellow indicators were still slightly visible while the cuff lock was in the fully locked position.The evaluation was unable to determine when or how the cuff lock locking arms became bent.The bent cuff lock arms would have caused the yellow indicators to be visible when the cuff lock was in the fully locked position.A specific root cause for the reported air entrapment could not be conclusively determined through this evaluation.Furthermore, a direct correlation between the bent locking arms of the cuff lock and the reported air entrapment could not be established.The remainder of the device appeared unremarkable.Examination of the blood-contacting surfaces found no depositions or defects.The pump was reassembled and operated on a mock circulatory loop and functioned as intended in accordance with manufacturing specification.The relevant sections of the device history records for (b)(4) were reviewed, including the cuff lock installation and inspection, and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on (b)(6) 2021.The heartmate 3 lvas instruction for use (ifu), rev.C, is currently available.Section 1 of this document lists stroke as an adverse event that may be associated with the use of the heartmate 3 left ventricular assist system.Section 6 ¿patient care and management¿ (under "anticoagulation") outlines the recommended anticoagulation regimen (including international normalized ratio (inr) range) for patients using the heartmate 3 lvas as well as the suggested anticoagulation modifications.The ifu provides instructions on all surgical procedures, including preparing the ventricular apex site and inserting the pump in the ventricle.The ifu cautions that after the apical cuff has been sewn to the heart, the metal ring on the apical cuff should extend above the felt surface to allow proper engagement and locking with the slide lock of the heartmate 3 left ventricular assist device (lvad).If the slide lock mechanism on the heartmate 3 lvad fails to engage, do not make further attempts to engage until retracting the slide lock mechanism.Evidence of slide lock mechanism failing to engage will be either visual evidence of the yellow ¿wings¿ or a tactile feel of three ridges versus one.The slide lock will not engage the apical cuff unless initially fully retracted.If difficulty persists when engaging the slide lock mechanism, the lvad should be removed from the apical cuff to visualize what might be preventing the connection.The suture knots should not interfere with the connection.If a sealing agent is used on or near the apical cuff, it should not interfere with the slide lock mechanism.The surgical procedures section also includes information on de-airing the pump during implant and warns that prolonged de-airation may be due to inadequate blood supply to the left ventricular assist device or a leak in the sealed outflow graft or sealed inflow cannula.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.

Event Description

It was reported that the patient had a head computed tomography (ct) scan on (b)(6) 2021 that revealed a questionable small infarct in the left anterior frontal lobe of an uncertain age.

• 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: 12565033
• MDR Text Key: 274449251
• Report Number: 2916596-2021-05332
• 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: Physician
• 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: 10/01/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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