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

Device Problem Fracture (1260)

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

Event Date 09/07/2017

Event Type  malfunction  

Manufacturer Narrative

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.One stent fracture occurred where no reintervention was performed, for which an image was provided within the article.

Manufacturer Narrative

A review of the manufacturing records for the devices could not be conducted because the lot numbers remain unknown.An imaging evaluation indicated the following: image received via (email) with no patient identifier or date of acquisition in image.Unable to manipulate image.There appears to be multiple devices implanted.There appears to be wire pattern disruption of the device proximal to the overlapping device and distal to the overlapping device.Unable to confirm the device that was used in the article.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 date, lot number and detailed description of the incident will not be shared by the author with gore.Additional case related images were requested but not provided by the author.Therefore, this event will be closed with the information received from the article.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.(b)(4).

• 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: 7224412
• MDR Text Key: 98735226
• Report Number: 2017233-2018-00057
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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 Age: 68 YR