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

Model Number	10005877
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient's weight has been estimated.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that a mini cuff was attempted to be used with thoracotomy approach.The pump could not be locked on to the sewing cuff after multiple attempts.The decision was made to remove the mini apical cuff and use the traditional cuff.The patient was in the intensive care unit (icu) at time of reported event on milrinone drops at 0.125 micrograms.The patient was working with a physical therapist.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported difficulty engaging the pump with the mini apical cuff could not be confirmed through this evaluation.A specific cause for this event could not be conclusively determined.The mini apical cuff was returned in used condition.Sutures were noted on the felt ring.The metal hardware appeared free from distortion, and no significant markings were observed.There was no material impeding the inner diameter of the hardware.The returned mini apical cuff was tested with a test heartmate 3 pump to attempt to engage the cuff lock mechanism.The mini apical cuff was able to be fully engaged and disengaged without issue.A specific cause for the reported inability to lock the pump to the mini apical cuff could not be conclusively determined.Heartmate 3 mini apical cuff kit instructions for use (ifu), rev.E., 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 relevant sections of the device history record for the mini apical cuff, lot number 7662090 were reviewed and showed no deviations from manufacturing or quality assurance specifications.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 (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11795050
• Report Number: 2916596-2021-02105
• Device Sequence Number: 4180762
• Product Code: DSQ
• UDI-Device Identifier: 00813024013082
• UDI-Public: 00813024013082
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2021

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: 09/24/2023
• Device Model Number: 10005877
• Device Catalogue Number: 10005877
• Device Lot Number: 7662090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 96