MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

Model Number 106524

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/08/2019

Event Type  Injury  

Manufacturer Narrative

Approximate age of device: 0 days.The replaced apical cuff was discarded and not returned to the manufacturer.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is complete.

Event Description

The patient was implanted with an extracorporeal circulatory support pump on (b)(6) 2019.It was reported that during the implant surgery the apical cuff was removed from the surgical accessory kit without use because the titanium ring appeared bent.The apical cuff was discarded at the site and a replacement was requested because it was under warranty.No images of the discarded part were available.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event could not be confirmed as no product was returned.It was later reported that no photos of the apical cuff were taken before it was discarded.Multiple requests for additional information, including the serial number of the lvas kit, were sent to the customer; however, no additional information was provided.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.

Event Description

Correction: the patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2019.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
• Type of Device: LEFT VENTRICULAR ASSIST SYSTEM
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 8452684
• MDR Text Key: 139877690
• Report Number: 2916596-2019-01215
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/27/2019

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
• Device Operator: Health Professional
• Device Model Number: 106524
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/11/2019
• Initial Date FDA Received: 03/26/2019
• Supplement Dates Manufacturer Received: 06/26/2019
• Supplement Dates FDA Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention