MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® HYBRID VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Catalog Number 0650HYB0805

Device Problems Difficult or Delayed Positioning (1157); Kinked (1339); Device Slipped (1584); Physical Resistance (2578)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/25/2014

Event Type  Injury  

Event Description

The patient presented with an aneurysm in the abdominal aorta.A dacron prosthesis (jotec flownit bioseal) was used for the aortic bifurcation procedure.A gore hybrid vascular graft was used for a debranching of the left internal iliac artery.It was reported to gore that when device deployment was initiated, the deployment of the nitinol reinforce section stopped after approximately ¾ of deployment.As further deployment was attempted, a high force was observed, and the medical device kinked and slipped out of the vessel.Even when the deployment line was cut, the medical device failed to deploy.There was no vessel dissection or rupture.The procedure was completed implanting another graft.The patient lost around 7 liters of blood during the whole procedure.It was stated that the procedure was performed in accordance with the instruction for use of the gore hybrid vascular graft and that no abnormalities were recognized.

Manufacturer Narrative

The review of the manufacturing records verified that this lot met all pre-release specifications.The engineering evaluation is currently in process.

Manufacturer Narrative

A gross evaluation of the device, with aid of a stereomicroscope, was performed.It was reported that cutting the deployment line did not deploy the device.Complete removal of the deployment system results in device expansion.The device was returned in a fully-expanded condition with no attached deployment system.The state of the received device was fully and not partially expanded.Tape damage and proximal migration, along with an experienced high force, is indicative of deployment line interaction with a distal-facing apex during deployment or interaction of the deployment line with expanded apices a result of kinking or other procedural handling.Cut nitinol and deployment line segments are likely the result of an attempt to cut the deployment line.Based on the provided information and state of the device, no anomalies could be attributed to the manufacture of the device during examination which would result in device malfunction or any potential patient harm.

• Brand Name: GORE® HYBRID VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: barbara ulrich ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 3690053
• MDR Text Key: 4289050
• Report Number: 2017233-2014-00137
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K093934
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2015
• Device Catalogue Number: 0650HYB0805
• Device Lot Number: 11661005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2014
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DACRON PROSTHESIS (JOTEC FLOWNIT BIOSEAL)
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 75