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

Model Number	10005877
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The approximate age of device: 1 day.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 the surgeon had difficulty with mini apical cuff.Instructions for use was not followed during implant and could not lock on the hm3 pump to the cuff once sutured to the heart.The surgeon had to remove this cuff from the heart and use a different apical cuff.No additional information was provided.
Event or Problem Description
Additional information: it was reported that instead of suturing the cuff on per ifu (instructions for use) the surgeon used multiple interrupted pledgeted sutures that were also farther away than the recommended distance from the cuff.The surgeon also used larger felt sections on the heart as well as bio glue.This caused severe bunching of heart tissue and the felt ring portion of the cuff to bunch and go concave keeping the pump from locking on.Also there were a lot of additional knots taking up space on top of the felt and these knots were problematic for the locking mechanism on the pump.No additional information was provided.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.
Additional Manufacturer Narrative
Manufacturer¿s investigation conclusion: the reported event could not be confirmed as no product was returned for evaluation.The center reported that the surgeon had difficulty with the mini apical cuff.It was reported that the ifu was not followed during implant and the surgeon could not lock on the hm3 pump to the cuff once sutured to the heart.The surgeon had to remove this cuff from the heart and use a different apical cuff.It was specified that instead of suturing the cuff on per the ifu, the surgeon used multiple interrupted pledgeted sutures that were also farther away than the recommended distance from the cuff.The surgeon also used larger felt sections on the heart as well as bio glue.This caused severe bunching of heart tissue and the felt ring portion of the cuff to bunch and go concave keeping the pump from locking on.It was also noted that there were a lot of additional knots taking up space on top of the felt and these knots were problematic for the locking mechanism on the pump.It was reported that the patient was stable at the time of the event.The patient remains ongoing on vad support.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.The heartmate 3 lvas ifu warns the user 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: 8408243
• Report Number: 2916596-2019-00908
• Device Sequence Number: 389147
• Product Code: DSQ
• UDI-Device Identifier: 00813024013082
• UDI-Public: 00813024013082
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 05/21/2019

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: 10/16/2021
• Device Model Number: 10005877
• Device Catalogue Number: 10005877
• Device Lot Number: 6688701
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/21/2019
• Supplement Date Received by Manufacturer: 03/14/2019; 05/20/2019
• Initial Report FDA Received Date: 03/11/2019
• Supplement Report FDA Received Date: 03/29/2019; 05/21/2019
• 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: 81 YR
• Patient Weight: 95