MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS MINI APICAL CUFF KIT

Model Number	10005877
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Approximate age of device- 0 days.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Event or Problem Description
The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2019.It was reported that there was difficulty locking down the pump.A forceful attachment was made but the locking mechanism locked into place but did not engage around the mini apical cuff.The t tool was used to unlock the cuff lock.The mini apical cuff was removed from the apex and the standard cuff was placed.The pump locked into place without difficulty.No 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 remained ongoing on (b)(6).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: HEARTMATE 3 LVAS MINI APICAL CUFF KIT
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 8825711
• Report Number: 2916596-2019-03533
• Device Sequence Number: 11347120
• Product Code: DSQ
• UDI-Device Identifier: 00813024013082
• UDI-Public: (01)00813024013082(10)6859122(17)220226
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/26/2022
• Device Model Number: 10005877
• Device Catalogue Number: 10005877
• Device Lot Number: 6859122
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/06/2019
• Supplement Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 07/25/2019
• Supplement Report FDA Received Date: 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Weight: 124