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

Catalog Number 0650HYB0805

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Necrosis (1971)

Event Date 05/25/2014

Event Type  Death  

Event Description

On (b)(6) 2014, the patient was treated for an aortic debranching procedure where four gore® hybrid vascular grafts were used.A cta measurement was performed of the celiac trunk, the two renal arteries and the superior mesenteric artery in order to treat a symptomatic mycotic aneurysm localized on the descending aorta to the distal abdominal aorta.The four gore® hybrid vascular grafts were sutured on a dacron prosthesis.The patient presented with an infection from the mycotic aneurysm.The medical device was flushed with the patient¿s blood and a thoracic laparotomy procedure was performed.The ischemic time for all visceral arteries was 26 minutes.It was reported to gore that thrombosis was observed in the left renal artery after implanting the medical device.It was stated that the graft portion of the hybrid appeared compressed at the end of the stent and was pressing against the bifurcation.Thrombectomy procedures were performed on all four gore® hybrid vascular grafts.It was stated that the left renal artery turned ischemic.The gore® hybrid vascular graft in the left renal artery was explanted and a classical bypass was performed with the remaining unused portion of the vascular graft from the gore® hybrid vascular graft.During the procedure, all the organ functions, except for the left renal artery, were good.Less urine was produced than expected.Good circulation was reported.The patient was closed from the procedure.Due to internal bleeding from the spleen, heparin was not administered during or after the procedure.The patient lost approximately 3 liters of blood during the procedure.On (b)(6) 2014, the patient collapsed and was in declining health.The three implanted gore® hybrid vascular grafts and the bypass graft were all occluded.The bowel, small intestines, liver and spleen were all necrotic.Thrombectomies of the medical devices and vessels were performed.The proximal ends of the grafts were shortened due to a slight rotation of the dacron graft.On (b)(6) 2014, it was reported to gore that the patient expired after another laparoscopic surgery and a collapse.

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-released 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: barbara ulrich ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 3880424
• MDR Text Key: 4569973
• Report Number: 2017233-2014-00319
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 05/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2014
• Device Catalogue Number: 0650HYB0805
• Device Lot Number: 10670837
• 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: 12/05/2012
• 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: 05/23/2014 DACRON PROSTHESIS AND 3 GORE® GRAFTS.
• Patient Outcome(s): Death
• Patient Age: 67 YR