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

Catalog Number 106524INT

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Blood Loss (2597)

Event Date 09/17/2017

Event Type  Injury  

Manufacturer Narrative

The patient¿s age and weight were not provided.(b)(4).: approximate age of device ¿ 8 months.The patient remains ongoing on lvad support.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) on (b)(6).It was reported that on (b)(6), the driveline was "stuck", and caused trauma to the driveline exit site.Bleeding from the exit site was treated with a surgical wound closure.It was reported that a 10 cm section of the driveline velour was externalized during the surgery.The surgeon confirmed that the driveline exit site showed no signs of infection before the event.The patient was reportedly well and was discharged home.No additional information was provided.

Manufacturer Narrative

A specific cause for the reported event could not be conclusively determined.Bleeding is listed in the instructions for use as a potential adverse event that may be associated with the use of the heartmate 3 left ventricular assist system.A review of the device history records revealed no deviations from manufacturing or quality assurance specifications.The patient remains ongoing on lvad support and no further issues have been reported.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, EUROPE
• 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: 6943302
• MDR Text Key: 89284046
• Report Number: 2916596-2017-02327
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 106524INT
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2016
• 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 Outcome(s): Hospitalization; Required Intervention