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

Catalog Number 0650HYB0805

Device Problems Difficult to Insert (1316); Detachment of Device or Device Component (2907)

Patient Problem Aneurysm (1708)

Event Date 12/16/2013

Event Type  Injury  

Event Description

On (b)(6) 2013, the patient presented with aneurysms in both iliac arteries measuring 6-7cm.A gore hybrid vascular graft was inserted into the right internal iliac artery and deployment was initiated.Following 2.5cm of deployment, the deployment stopped.The physician did not feel the deployment line break and did not note any bowstringing.As the physician pulled out the partially deployed graft, 2.5cm of the internal iliac artery was damaged.To repair the damage, the physician attempted a second gore hybrid vascular graft but could not insert the graft due to a shortened healthy landing zone.A vascular graft (manufacturer unknown) was then sewn to the vessel and the patient was doing well following the procedure.

Manufacturer Narrative

The examination found no anomalies attributable to the manufacture of the device.The examination found no anomalies attributable to the manufacture of the device.

• 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: 3603570
• MDR Text Key: 4088297
• Report Number: 2017233-2014-00041
• 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
• Report Date: 12/16/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2015
• Device Catalogue Number: 0650HYB0805
• Device Lot Number: 11810347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2013
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2013
• 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
• Patient Outcome(s): Other
• Patient Age: 52 YR