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

Model Number	10005877
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/02/2019
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 the implant procedure, the mini cuff used and placed utilizing 12 pledgeted sutures was faulty.Proper spacing noted (within 1 cm of cuff).The surgeon had difficulty locking pump onto cuff.It was reported that the surgeon attempted to trim knots and replaced some that may have been obstructing the cuff lock however the pump could not attach.A decision was made to remove the mini cuff and dispose and use a regular cuff.There were no issues with regular cuff engaging to pump.There were no reported adverse patient consequences.No additional information 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 reported event could not be confirmed as no product was returned for evaluation.The account communicated that the mini apical cuff was used during implant and placed utilizing 12 pledgeted sutures.Proper spacing was noted, within 1 cm of the cuff.There was difficulty locking the pump onto the cuff.An attempt was made to trim the knots.Some of the knots that may have been obstructing the cuff lock were replaced, and the pump still could not be attached.No alarms were reported for this event.The decision was made to remove the mini apical cuff and use the regular cuff.There were no issues with the regular cuff engaging to the pump.The mini apical cuff was discarded.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6) and no additional complaints have been reported at this time.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.
Additional Manufacturer Narrative
Section g4: manufacturers aware date was inadvertently omitted from previous report.The correct date was aug 15, 2019.

• 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: 8614273
• Report Number: 2916596-2019-02251
• Device Sequence Number: 2075296
• Product Code: DSQ
• UDI-Device Identifier: 00813024013082
• UDI-Public: 00813024013082
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/20/2019

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: 01/10/2022
• Device Model Number: 10005877
• Device Catalogue Number: 10005877
• Device Lot Number: 6782312
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 05/06/2019; 08/20/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 08/19/2019; 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 77