MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES,INC GORE VIABAHN ENDOPROSTHESIS; NIP/ STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number VBJ061002

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Death (1802); Cardiac Enzyme Elevation (1838); Renal Failure (2041); Thrombus (2101); Stenosis (2263)

Event Date 01/12/2014

Event Type  Death  

Event Description

Hold af 02/04 on (b)(6) 2014 a pt presented for an abdominal aortic aneurysm procedure.Several gore medical devices were implanted, including two gore viabahn endoprostheses.A snorkel technique was used and a gore viabahn endoprosthesis was implanted in each renal artery.Cat scan angiogram showed the left renal artery had stenosis that led to atrophy of the left kidney.Extensive thrombus was also observed throughout the aneurysm.At the completion of the procedure, the pt had excellent angiographic result.Endoleak was not present and the aneurysm was completely sealed.Shortly after the procedure, the pt complained of severe abdominal pain.An abdominal aortogram and angiography of the mesenteric vessels were performed with patency results.Cat scan of the abdomen showed normal results.A repeat cat scan was performed several hours later, again confirming no acute findings.Pt's blood test revealed elevated lipase level significant with likely ischemic pancreatitis.On (b)(6) 2014, conservative treatment was initiated for the development of the acute renal failure after the implant procedure.Pt never required kidney dialysis.A repeat cat scan was performed on (b)(6) 2014, which revealed three new ischemic infarcts consistent with embolic phenomenon.The scan also revealed some fluid in the paracolic gutter.An exploratory laparotomy found pt to have extensive large and small bowel infarction with very limited amount of a viable intestine.The discharge summary states that on (b)(6) 2014, the pt expired due to mesenteric infarction and renal failure in the setting of abdominal aortic aneurysm.

Manufacturer Narrative

Medwatch report # 2017233-2014-00023 submitted for gore viabahn endoprosthesis (lot number # 10124386).Results: review of device manufacturing record history confirmed device met pre-release specifications.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS
• Type of Device: NIP/ STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W.L. GORE & ASSOCIATES,INC; flagstaff AZ
• Manufacturer Contact: genevieve begay ; 3250 w kiltie lane; flagstaff, AZ 86005 ; 9285263030
• MDR Report Key: 3603941
• MDR Text Key: 4089298
• Report Number: 2017233-2014-00024
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040037
• 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: 01/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Catalogue Number: VBJ061002
• Device Lot Number: 10418795
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2012
• 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: GORE VIABAHN ENDOPROSTHESIS (LOT NUMBER #10124386)
• Patient Outcome(s): Death
• Patient Age: 72 YR
• Patient Weight: 83