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 Consequences Or Impact To Patient (2199)
Date of Event	10/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that during implant the surgeon was unable to successfully lock hm3 device into mini apical cuff even after multiple attempts were made.Surgeon removed mini apical cuff and sutured the original apical cuff from the implant kit onto the left ventricular apex and was able to successfully lock the device.Mini cuff removed and replaced with original apical cuff, pump locked without issue.No further or additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: a direct cause for the reported difficulty in securing the pump to the mini apical cuff could not be conclusively determined through this evaluation.The patient remains ongoing on (b)(4).The mini apical cuff was discarded.The surgical procedures section of the hm3 mini apical cuff kit ifu explains how to prepare the mini apical cuff and the apical cuff holder for use.The directions for use section of this document 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.This section also stated that if a sealing agent is used on or near the mini apical cuff, ensure that it does not interfere with the slide lock mechanism.In addition, the heartmate 3 lvas ifu warns that a complete backup system 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.

• 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 95488
• MDR Report Key: 9235829
• Report Number: 2916596-2019-05074
• Device Sequence Number: 2233341
• Product Code: DSQ
• UDI-Device Identifier: 00813024013082
• UDI-Public: 00813024013082
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/26/2022
• Device Model Number: 10005877
• Device Catalogue Number: 10005877
• Device Lot Number: 6864321
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 12/04/2019
• 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: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 92