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

Model Number	10005877
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during implant the surgeon used a bilateral thoracotomy approach.The pump was initially attempted to lock onto the mini cuff as used in standard practice for the surgeon, but heart tissue was believed to be getting in the way preventing the locking mechanism.The team initially worked to ensure nothing was in the channel of the pump that would block the pump from locking onto the mini cuff.Additional stiches were put around the mini cuff ensuring nothing was impeding the locking mechanism, while the pump was taken out of the chest and placed in sterile injectable saline.The team also used the sterile regular cuff at one point to ensure the pump locked into place without difficultly.After some time, the team aborted the mini cuff, removing it from the apex of the heart and replaced it with the regular cuff.The pump locked on without difficulty and the implant proceeded.The patient is stable.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Additional Manufacturer Narrative
Manufacture¿s investigation conclusion: the reported event of the pump not engaging to the mini apical cuff could not be confirmed as no product was returned for evaluation and no images were submitted for analysis.Although a specific cause for the reported event could not be conclusively determined through this evaluation, the account indicated that there appeared to be heart tissue preventing the pump from locking to the mini apical cuff.Heartmate 3 mini apical cuff kit instructions for use (ifu) is currently available.The section entitled ¿surgical procedures¿ explains how to prepare the mini apical cuff and the apical cuff holder for use.Section ¿directions for use¿ explains how to secure the mini apical cuff to the ventricle.This section also instructs the user that the mini apical cuff should be affixed only by the sew-then-cut method and pledgets should be placed no more than one and a half centimeters from the edge of the felt.Affixing the mini apical cuff using methods other than the prescribed technique can lead to challenges engaging the slide lock mechanism.The heartmate 3 left ventricular assist system (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 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.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.The relevant sections of the device history records for the mini apical cuff were reviewed and showed no deviations from manufacturing or quality assurance specifications.Review of the manufacturing documentation for (b)(6) found no deviations during installation, testing and inspection of the cuff lock during pump assembly.The assembly and inspection steps for the cuff lock include checking for damage, cycling the lock 10 times, engaging the lock with a dummy apical cuff, and additional inspections for damage, bends, and that the cuff lock arm pegs are properly positioned in the motor cap grooves.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS MINI APICAL CUFF KIT
• Common Device Name: 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: 15662427
• Report Number: 2916596-2022-14233
• Device Sequence Number: 2809953
• Product Code: DSQ
• UDI-Device Identifier: 00813024013082
• UDI-Public: 00813024013082
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/12/2025
• Device Model Number: 10005877
• Device Catalogue Number: 10005877
• Device Lot Number: 8441732
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2022
• Supplement Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 119 KG