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

Catalog Number PAJ050502

Device Problem Leak/Splash (1354)

Patient Problems Death (1802); Hemothorax (1896); Rupture (2208)

Event Date 10/27/2014

Event Type  Death  

Event Description

On (b)(6) 2014 the patient was implanted within the (b)(4) with a conformable gore® tag® thoracic endoprosthesis to treat a penetrating aortic ulcer of the paravisceral aorta.The cephalic, superior mesenteric, right and left renal artery were stented in the same procedure with five gore® viabahn® endoprostheses.On (b)(6) 2014 the patient suffered on acute kidney injury.The renal stent grafts showed thrombosis bilaterally.The patient was treated with an arteriovenous fistula (avf) where a gore® acuseal vascular graft was implanted to receive hemodialysis.On (b)(6) 2014 a right hemothorax occurred, caused by endoleak type i proximal and following rupture of the artery.On the same day the patient received an additional conformable gore® tag® thoracic endoprosthesis which was used to seal the rupture.The procedure was converted to open repair.Followed by the procedure the patient passed away on (b)(6) 2014.

Manufacturer Narrative

Additional imaging evaluation was performed with focus on the implanted viabahn devices in the cephalic, superior mesenteric, right and left renal artery.

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.It was reported to gore, that it is not possible to determine the lot numbers of the gore® viabahn® endoprostheses which were implanted in the left and right renal artery and which occluded on (b)(6) 2014.Therefore all five provided lot numbers will be reported to the national competent authority.

Manufacturer Narrative

(b)(4).

• 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: barbara ulrich ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4478676
• MDR Text Key: 5504384
• Report Number: 2017233-2015-00060
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: PAJ050502
• Device Lot Number: 12343814
• 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: 03/13/2014
• 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: 66 YR
• Patient Weight: 67