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

Catalog Number 106524

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Unspecified Infection (1930)

Event Date 08/26/2017

Event Type  Injury  

Manufacturer Narrative

The heartmate 3 lvas was implanted during the (b)(6) clinical trial, (b)(6).Fda approval for heartmate 3 lvas was received on 23 august 2017.The same device is used commercially and in the ongoing (b)(6) trial.(b)(4).Approximate age of device ¿ 4 months.  the patient remains ongoing with the device.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) 2017.It was reported that the driveline was tugged when trying to catch a falling relative.The patient presented to the emergency room with driveline infection and was treated with vancomycin infusion for 2 days then transitioned to oral doxycycline.The patient was admitted overnight.Wound cultures showed no growth after 4 days.No additional information was provided.

Manufacturer Narrative

A specific cause for the reported driveline infection could not be conclusively determined.The patient remains ongoing on lvad support.The product was not available for investigation.Infections are listed in the instructions for use as a potential adverse event that may be associated with the use of heartmate ii left ventricular assist system.A review of the device history records, including sterilization and packaging documentation, found no deviations from manufacturing specifications.No further information was provided.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: 6880622
• MDR Text Key: 87174014
• Report Number: 2916596-2017-02109
• 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: health professional,study
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 106524
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2016
• 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
• Patient Age: 69 YR
• Patient Weight: 76