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

Model Number 106524US

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/28/2022

Event Type  malfunction  

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 during pump placement the surgeon wanted to unlock the pump to reposition after the pump was locked into place.The clinical specialist went to the head of the bed and demonstrated proper use of the device unlocking tool.The surgeon attempted to use the proper unlocking tool.The clinical specialist advised to use caution with force and use of other tools to pull the clip out.Once the clip was unlocked, the surgeon noticed a wing of the clip was bent out of place.The clinical specialist advised that the pump was harmed and could cause potential for interruption to the apical cuff and pump lock engagement.The surgeon acknowledged the warning and proceeded to bend the dislodged portion of the clip back in to place.The pump was placed back into the apical cuff and locked into place with no evidence of bleeding or malposition.The patient was successfully weaned onto left ventricular assist device (lvad) support and was doing well.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of damage to the cuff lock was confirmed by abbott personnel that attended the implant procedure.The patient remains ongoing on vad support with no further issues report.The relevant sections of the device history records were reviewed and showed no deviations from mfg or qa specifications.Heartmate 3 lvas ifu rev.C provides instructions on all surgical procedures, including preparing the ventricular apex site and inserting the pump in the ventricle.This section provides steps to follow if the orientation of the pump requires adjustment.The hm3 ifu warns not to try to repair any of the heartmate 3 system components.The heartmate 3 lvas surgical hand tools are shipped with heartmate 3 lvas surgical hand tools instructions for use (rev.A).The general information section explains that the heartmate 3 unlock tool is an optional tool that can be used to open the slide lock mechanism.The using the unlock tool section provides steps to follow to open the slide lock.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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 15031333
• MDR Text Key: 304555399
• Report Number: 2916596-2022-12187
• 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: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7960210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2021
• 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 Age: 49 YR
• Patient Sex: Male
• Patient Weight: 112 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White