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

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

Udi # remain unknown.(b)(4).The article stated that two gore viabahn® endoprostheses were involved in the medical device incident.Multiple attempts have been made from the product surveillance coordinator to the author in order to get the lot numbers of the devices.As no further information related to this case has been or will be provided by the author, gore is submitting one report for the medical devices involved in the incident.Since the actual date of the incident is not available the year (january 1, 2016) when the patient was treated with the medical device was used as an estimated date of the incident.

Event Description

Within the article ¿endovascular repair of 40 visceral artery aneurysms and pseudoaneurysms with the viabahn stent-graft: technical aspects, clinical outcome and mid-term patency¿, published by massimo venturini et al, within the (b)(6) 2017, clinical investigation abstract, accepted on november 13, 2017, the published results indicated the following: the purpose of this single-center study was to retrospectively report a 14-year experience with the peripheral, self-expandable viabahn stent-graft in the endovascular repair of 40 visceral artery aneurysms (vaa) and visceral artery pseudoaneurysms (vapa).As primary outcomes, peri-procedural complications, technical success 30-day clinical success, re-interventions and 30-day mortality were assessed.As secondary outcomes, stent-graft patency and persistent aneurysm devascularization at mid- (6¿12 months) and long-term (more than 12 months) were assessed.Patient b19 (male/(b)(6)) presented with a vapa within the middle gastroduodenal artery, which was treated with two gore® viabahn® endoprostheses (7 mm x 2,5 cm; 7 mm x 2,5 cm), where the approach was gained through the right femoral artery, in an emergency procedure 2016 suffered from a re-bleeding of the gastroduodenal artery stump which required a reintervention with a gore® viabahn® endoprosthesis.

• 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: 7128707
• MDR Text Key: 95213765
• Report Number: 2017233-2017-00658
• 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
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• 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