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

Device Problem Occlusion Within Device (1423)

Patient Problem No Code Available (3191)

Event Date 09/07/2017

Event Type  Injury  

Manufacturer Narrative

Until further information will be received, gore is submitting one report for the reported occlusions.Since the actual date of the incident is not available the date of when the article was published is used as an estimated date of the incident.

Event Description

Within the article ¿long-term outcome of endovascular popliteal artery aneurysm repair¿, published by bahar golchehr et al, within an article in press printed by the society for vascular surgery, accepted on september 7, 2017, the published results indicated the following: the aim of this study was to describe the long-term outcome of endovascular repair of popliteal artery aneurysm (paa) with endografts.The gore® hemobahn device was mainly used until 2004 and gore® viabahn® endoprosthesis after 2004.All patients with a paa were treated between june 1998 and november 2014 in a tertiary referral center were prospectively gathered in a database and retrospectively analyzed where patients¿ data were investigated anonymously.The primary end point of this study was primary patency.Secondary end points included primary assisted and secondary patency, survival of the patient, stent fractures, secondary interventions, and limb loss.A total of 75 paas were treated in 64 patients with a mean age of 68 years.Unilateral paa was present in 39 patients and bilateral paas in 25 patients, of which 11 were treated bilaterally.Median follow-up was 68 months.Two occlusions occurred within 1 month and during hospital stay; one case with an acute occlusion was successfully treated with thrombolysis, and the other case was treated with a surgical bypass.

Manufacturer Narrative

A review of the manufacturing records for the devices could not be conducted because the lot numbers remain unknown.The devices are unavailable, so no engineering evaluation can be performed.Feedback was received from the author that patients¿ data were investigated retrospectively and anonymously.Therefore, no patient details will be provided.It was also stated that additional requested information like implant dates, lot numbers and detailed description of the incidents will not be shared by the author with gore.Therefore, this event will be closed with the information received from the article and gore is submitting one report for the reported occlusions.The instruction for use for gore® viabahn® endoprosthesis states that complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: stenosis, thrombosis or occlusion.(b)(4).

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7224088
• MDR Text Key: 98411443
• Report Number: 2017233-2018-00055
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Type of Report: Initial,Followup
• Report Date: 01/29/2018

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/29/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR