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

Catalog Number 0650HYB0810A

Device Problem Difficult to Remove (1528)

Patient Problems Unspecified Infection (1930); Device Embedded In Tissue or Plaque (3165)

Event Date 09/22/2014

Event Type  Injury  

Event Description

A gore® hybrid vascular graft (hvg) was implanted during an av access procedure.The graft was implanted in the left upper arm with the nitinol reinforced section (nrs) of the hvg placed in a bard flair bare metal stent which extended into the left axillary artery.A few days after hvg implant, the physician suspected an arterial anastomosis infection.On (b)(6) 2014, the hgv was explanted.The distal portion of nrs was unable to be removed from the bard flair stent and had to be cut for the hgv removal.The bard flair stent and a portion of the nrs remained implanted.

Manufacturer Narrative

Review of the manufacturing paperwork has been conducted.The review of the manufacturing paperwork verified that this lot met all pre-release specifications.Investigation is in progress pending completion of the sterilization device history review.

Manufacturer Narrative

Review of the sterilization paperwork has been conducted.The review of the sterilization paperwork verified that this lot met all pre-release specifications.

• 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: roger smith ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4245524
• MDR Text Key: 5051433
• Report Number: 2017233-2014-00590
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2015
• Device Catalogue Number: 0650HYB0810A
• Device Lot Number: 11180969
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2013
• 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: BARD FLAIR STENT
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR