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

Model Number 106524US

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384); Misconnection (1399); Device Difficult to Setup or Prepare (1487)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/17/2022

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 there was a pump locking mechanism failure during implant.The pump was reportedly put in and was running for over an hour which meant the patient had to go back on bypass due to the bleeding.The tbar was used to remove the heartmate 3 (hm3), and an extensive amount of clotted blood was found between the pump and apical cuff.The surgeon performed a running suture and put the pump back on, however 1 side still had excessive bleeding.For this reason, the pump was once again removed and 3 large pledgets were used to stop the bleeding.The surgeon reportedly tried multiple times to put the pump back in but the locking mechanism would not lock.To troubleshoot this, the surgeon tried to lock the locking mechanism to the mini cuff but the pump would not engage it either.Further inspection of the locking mechanism showed that the purple billeted tab was severely bent upwards.A different implant kit was opened and successfully implanted on the patient with no issues.

Manufacturer Narrative

Manufacturer's investigation conclusion: evaluation of heartmate 3 left ventricular assist system (lvas) confirmed damage to the cuff lock latch arm.A specific cause for this damage and the reported blood leak could not be conclusively determined through this evaluation.The device was returned assembled with the pump cable intact.The sealed outflow graft and the outflow graft bend relief were not returned.The apical cuff and modular cable were not returned.The cuff lock was returned disengaged.Visual examination of the cuff lock revealed that the cuff lock latch arm was bent out of plane and toward the locking arms.Measurements were taken of the cuff lock and both the locking arms were within specification.The clear sealing ring and hardware feature on the motor cap that the sealing ring is seated around also measured within specification.Review of manufacturing documentation, which includes functional testing and visual inspection of the cuff lock for bent latch and cuff lock arms, found no deviations in manufacturing or quality assurance specifications.No test engagement using the returned cuff lock was able to be performed post-cleaning due to the confirmed damage on the latch arm.Although the exact time that the cuff lock latch became bent could not be determined, the damage could have occurred during the repeated attempts to troubleshoot the blood leak and re-engage the pump.The remainder of the device appeared unremarkable.Examination of the blood-contacting surfaces found no depositions, thrombus formations, 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 were reviewed and showed no deviations from manufacturing or quality assurance specifications.Heartmate 3 lvas instructions for use (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 lvas.Ensure that apposition between the myocardial tissue and the cuff felt is continuous and sufficiently forceful to prevent bleeding.Bleeding is listed in this document as an adverse event that may be associated with the use of the heartmate 3 lvas.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 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.

Manufacturer Narrative

No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• 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: 14935151
• MDR Text Key: 295360214
• Report Number: 2916596-2022-11899
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2024
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8484374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: FA-Q124-HF-2
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 48 KG