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

Catalog Number VBJ080502

Device Problem Fluid/Blood Leak (1250)

Patient Problems Death (1802); Extravasation (1842)

Event Date 03/26/2014

Event Type  Death  

Event Description

On (b)(6) 2014, the patient presented with stenotic lesions in the right and left common iliac arteries.Several gore viabahn endoprostheses were used to treat the highly calcified lesions.Two 8x5 gore viabahn endoprostheses were positioned in the proximal left and right arteries.Both devices were deployed simultaneously and then ballooned.A marking pigtail catheter was placed in the aorta for imaging.The contrast injected through the pigtail catheter revealed extravasations.One gore viabahn endoprosthesis was deployed distally, overlapping the first device in the left iliac artery.Further imaging revealed the leak was originating from the distal aorta / bifurcation where heavy calcium was concentrated.A 13x2.5 gore viabahn endoprosthesis was deployed in the distal aorta.Two 9x5 gore viabahn endoprostheses were positioned side-by-side, extending into left and right iliac arteries, and deployed within the 13x2.5 gore viabahn endoprosthesis.Imaging showed continued leakage.A 13x10 gore viabahn endoprosthesis was deployed in the distal aorta, extending into the right iliac artery.The patient was taken to the operating room for a surgical conversion.On (b)(6), 2014, the patient expired.The patient had previous endarterectomy, which the physician was not aware of prior to this procedure.

Manufacturer Narrative

Review of device manufacturing record history confirmed device met pre-release specifications.Concomitant medical products - additional gore viabahn endoprosthesis implanted during same procedure: lot# 10558474, mfr report #2017233-2014-00214; lot# 11191954, mfr report #2017233-2014-00212; lot# 10990903, mfr report #2017233-2014-00210; lot# 11711479, mfr report #2017233-2014-00216; lot# 11911825, mfr report #2017233-2014-00214; lot# 11762084, mfr report #2017233-2014-00211.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86001
• Manufacturer Contact: genevieve begay ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 3773664
• MDR Text Key: 4437118
• Report Number: 2017233-2014-00215
• 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: 03/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: VBJ080502
• Device Lot Number: 11985920
• 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: 11/26/2013
• 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): Death
• Patient Age: 73 YR
• Patient Weight: 50