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

Catalog Number 0650HYB0605

Device Problem Occlusion Within Device (1423)

Patient Problem Thrombus (2101)

Event Date 02/10/2014

Event Type  Injury  

Manufacturer Narrative

W.L.Gore & associates received the information that the patient is currently receiving dialysis treatment.

Event Description

On (b)(6) 2014, the patient presented with an aneurysm in the visceral arteries.Two dacron bifurcated grafts and two gore hybrid vascular grafts were used for the procedure.The two dacron grafts were implanted in the visceral arteries and the two gore hybrid vascular grafts were used for the debranching procedure of the renal arteries.When the hybrid vascular graft was inserted in the left renal artery, a high friction was observed, but the medical device deployed successfully.After the procedure an x-ray was performed and showed a thrombus on the anastamosis between the dacron graft and the gore hybrid vascular graft on the left renal artery side.A thrombectomy was performed and resulted with a good distal blood flow.On (b)(6) 2014, it was observed that both gore hybrid vascular grafts were occluded and the renals were no longer supplied with blood.

Manufacturer Narrative

The review of the manufacturing records verified that this lot met all pre-release specifications.The device remains implanted, so no engineering investigation could be performed.

• 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: 3649008
• MDR Text Key: 11695906
• Report Number: 2017233-2014-00101
• 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: 02/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2015
• Device Catalogue Number: 0650HYB0605
• Device Lot Number: 11638764
• 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: 08/05/2013
• 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: - TWO DACRON BIFURCATED GRAFTS
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 50