MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 TUNNELING ADAPTER

Catalog Number 1009061

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 09/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Approximate age of device ¿ the day of implant.The lvad remains in use supporting the patient; however, the tunneling adapter is expected to be returned for analysis.It has not yet been received.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 during the implant process, while tunneling the driveline through the subdermal abdominal tissue, a piece of one leaflet of the tunneling adapter broke off and was lost inside the tunnel.The surgeon tried to locate the broken piece of the adapter inside the tunnel without success.The patient did not experience any adverse sequelae.No additional information was provided.

Manufacturer Narrative

The report that one of the leaflets of the heartmate 3 tunneling adapter broke off during the implantation of the lvad was confirmed through the evaluation of the returned part.Analysis of the fracture faces under a microscope revealed striations indicative of the leaflet being bent away from the central axis, ultimately leading to failure.A review of the device history records revealed no deviations from manufacturing or quality assurance specifications.The report of leaflets breaking off from the tunneling adapter is being assessed through the manufacturer¿s corrective and preventive action process.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 TUNNELING ADAPTER
• Type of Device: TUNNELING ADAPTER
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: kathy reilly ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 9257380163
• MDR Report Key: 6937637
• MDR Text Key: 89756867
• Report Number: 2916596-2017-02284
• 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: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1009061
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2017
• 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: 66 YR
• Patient Weight: 77