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

Device Problem Insufficient Information (3190)

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

Event Date 01/01/2013

Event Type  Injury  

Manufacturer Narrative

The device was not returned.Consequently, direct product analysis was not possible.Lot number was not available, so manufacturing evaluation could not be conducted.Additional information about this event could not be obtained.As a result, no further investigation is possible.Year 2017 is the date listed in the article, therefore gore is using 01/01/2017 as the date of the incident.The actual incident date is unknown.(b)(4).

Event Description

Accepted article "endovascular treatment of visceral artery aneurysms and pseudoaneurysms in 100 patients: covered stenting vs transcatheter embolization" (massimo venturini, m.D.; paopo marra, m.D.; michele colombo, m.D.; marco alparone, m.D.; guila agostini, m.D.; luca bertoglio, m.D.; claudio sallemi, m.D.; marco salvioni, m.D.; simone gusmini, m.D.; gianpaolo balzano, m.D.; renata caltellano, m.D.; luca aldrighetti, m.D.; yamume tshomba, m.D.; massimo falconi, m.D.; germano melissano, m.D.; francesco de cobelli, m.D.; roberto chiesa, m.D.; and alessandro del maschio, m.D.; journal of endovascular therapy; doi: 10.1177/1526602817717715) was reviewed.This article is a retrospective report from a large single-center experience of visceral artery aneurysms and pseudoaneurysms treated with covered stents as the first therapeutic option.Page 4 of the article identifies one patient who experienced 'rebleeding' and underwent surgical removal of the stent.

Manufacturer Narrative

(b)(4).Since the actual date of the incident is not available the year ((b)(6) 2013) when the patient was treated with the medical device was used as an estimated date of the incident.(b)(4).

Event Description

Patient (male/(b)(6)) presented with a vapa within the hepatic artery proximal, which was treated with one gore® viabahn® endoprosthesis (7mm x 2,5cm), where the approach was gained through the right femoral artery, in an emergency procedure 2013 suffered from a septic fluid collection, originating from the pancreatic fistula and communicating with the gastric cavity, around the stented hepatic artery.The patient required re-intervention due to a re-bleeding from the celiac trunk-common hepatic artery and, after surgical ligation of the two vessels, the stent was removed from the stomach.Liver parenchyma was supplied from collaterals, without ischemic sequelae.

Manufacturer Narrative

Event date was corrected from (b)(6) 2017, to (b)(6) 2013, as well as further information from the literature article was included in the event description.

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 cardiovascular and interventional radiological society of (b)(4) 2017, clinical investigation abstract, accepted on (b)(4) 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 (b)(6) presented with a vapa within the hepatic artery proximal, which was treated with one gore® viabahn® endoprosthesis (7mm x 2,5cm), where the approach was gained through the right femoral artery, in an emergency procedure 2013 suffered from a septic fluid collection, originating from the pancreatic fistula and communicating with the gastric cavity, around the stented hepatic artery.The patient required re-intervention due to a re-bleeding from the celiac trunk-common hepatic artery and, after surgical ligation of the two vessels, the stent was removed from the stomach.Liver parenchyma was supplied from collaterals, without ischemic sequelae.

• 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: 6969811
• MDR Text Key: 89995284
• Report Number: 2017233-2017-00547
• 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,Followup
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/23/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/19/2017; 01/26/2018
• 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: 66 YR