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

Catalog Number 106524

Device Problem Cut In Material (2454)

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

Event Date 01/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Approximate age of device ¿ 1 day.The device was returned for investigation.The evaluation is not yet complete.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was implanted with a left ventricular assist device (lvad).It was reported that during the pump implant procedure, the surgeon mistakenly cut the pump's driveline.Another pump was used to complete the implant procedure.No further information was provided.

Manufacturer Narrative

The report of a severed pump cable was confirmed.The pump was returned assembled with the pump cable cut approximately 16 inches from the terminus of the pump end bend relief.It was reported that the surgeon mistakenly severed the pump cable during the patient's pump exchange.The distal end of the pump cable, measuring approximately 10 inches in length, was also returned.The modular cable was not returned.The sealed outflow graft and the sealed outflow graft bend relief were not returned.The apical cuff was not returned.Upon disassembly of the returned pump, examination of the pump blood-contacting surfaces revealed no depositions.The returned pump was cleaned, rebuilt, and functionally tested on a mock circulatory loop.The device operated as intended and in accordance with manufacturing specifications.A review of the device history records revealed no deviations from manufacturing or quality assurance specifications.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
• Type of Device: LEFT VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 7818528390
• MDR Report Key: 7209253
• MDR Text Key: 97984955
• Report Number: 2916596-2018-00269
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2020
• Device Catalogue Number: 106524
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 72