MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® VIABAHN® ENDOPROSTHESIS; NIP

Device Problem Complete Blockage (1094)

Patient Problem Claudication (2550)

Event Date 10/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Within the article ¿need for hypogastric artery preservation in endovascular repair for aorto - iliac aneurysms¿, published by rocco giudice et al, within the e journal of cardiovascular medicine, published on october 15, 2016, the published results indicated the following: from january 1999 to june 2016, 749 patients underwent endovascular repair of abdominal aortic aneurysm.Among these, 112 with aneurysm involving the iliac vessels required consideration for closing one (95) or both (17) hypogastric arteries.103 patients were male and 9 were female.The mean age was 75.Preservation of the hypogastric artery was achieved in 21 out of the 22 target vessels: one patient, treated with plug embolization on one side and a cook zenith ibd on the contralateral one, experienced immediate occlusion of the hypogastric stent (gore® viabahn® endoprosthesis) that was detected on the completion angiogram at the end of the procedure, with failed attempt of recanalization.Nevertheless, the patient did not experience severe clinical sequelae but only a mild buttock claudication persistent in the follow-up.

Manufacturer Narrative

No further information related to this incident will be provided by the author.Since the actual date of the incident is not available the date of the article was used as an estimated date of the incident.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: barbara ulrich ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6968052
• MDR Text Key: 89921529
• Report Number: 2017233-2017-00546
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 75 YR