MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION TUNNELER; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Device Problems Fracture (1260); Material Separation (1562); Material Perforation (2205)

Patient Problem Blood Loss (2597)

Event Date 12/05/2019

Event Type  Injury  

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.

Event Description

During a review of the fda maude adverse event data base a report submitted to the fda by gore (2017233-2020-00031) it was noted that an atrium tunneller was used in the procedure.The patient underwent an axillary to bifemoral artery bypass procedure.A reintervention took place using a gore propaten vascular graft.During the reintervention there was bleeding noted midgraft after tunnelling with an atrium tunneller.This required the use of pledgets for patching.Mild traction was placed on the graft during the procedure and this resulted in the graft fracturing and separating from the axillary end.A 6 mm atrium tunneller was passed through the graft but it perforated the graft at the groin end.The entire graft was explanted.The status of the patient is unknown currently.

Event Description

N/a.

Manufacturer Narrative

During a review of the fda maude adverse event database, in a report submitted to the fda by gore (2017233-2020-00031), it was noted that an atrium tunneler was used in a procedure.The patient underwent an axillary/bifemoral artery bypass.A re-intervention took place using a gore propaten vascular graft.During the re-intervention there was bleeding noted mid-graft after tunneling with an atrium tunneler.This required the use of pledgets for patching.Mild traction was placed on the graft during the procedure and this resulted in the graft fracturing and separating from the axillary end.A 6 mm atrium tunneler was passed through the graft but it perforated the graft at the groin end.The entire graft was explanted.There are no other details regarding this event.Key information to make an assessment of the failure mode is not available.Key information would be the diameter of the gore propaten vascular graft that was in place.How long the graft had been in place and the reason for the re-intervention of the gore graft.Other information not provided was the lot number of the tunneler used in this procedure.The tunneler system was not designed to tunnel inside of a graft.The tunneler system per the indications for use states the following: "the vascular graft tunneler instrumentation is indicated for use as a device to create a subcutaneous tunnel for placement of a vascular prosthesis or autogenous graft for peripheral and extra-anatomic bypass procedures, and for vascular access." in this regard tunneling through a graft that has been placed would be and is considered misuse/user error of the device.It is unknown why the physician decided to thread a tunneler into a previously placed graft.H3 other text: not available for return.

• Brand Name: TUNNELER
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 10492223
• MDR Text Key: 205662300
• Report Number: 3011175548-2020-01106
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GORE PROPATEN VASCULAR GRAFT.; GORE PROPATEN VASCULAR GRAFT.
• Patient Outcome(s): Required Intervention