MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS - 3; NIP

Catalog Number PAH101002

Device Problems Complete Blockage (1094); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aneurysm (1708); Unspecified Infection (1930); Claudication (2550)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Literature citation: 'pet ct to confirm an infected popliteal stent graft used to treat popliteal artery aneurysm' (stuart walker, m.D.; eur j vasc endovasc surg (2017) 54, 612) concomitant medical products.Additional devices: pah111002 udi: (b)(4); pah110502 udi: (b)(4).It is not known which device(s) became occluded/infected, therefore all were included in the investigation.

Event Description

The following information was reported to gore: in an abstract 'pet ct to confirm an infected popliteal stent graft used to treat popliteal artery aneurysm' (stuart walker, m.D.; eur j vasc endovasc surg (2017) 54, 612) was reviewed.The abstract discusses a viabahn implant, and focuses on the case 4 years post implant.It is identified that 4 years post implant the stent occluded, but this was associated with mild claudication and was managed conservatively.Two months later, the patient presented with a left popliteal abscess; drainage yielded proteus mirabilis.Following oral cotriboxazole treatment, the patient is asymptomatic but has declined removal of the infected stent graft.In communication with the author, the date of implant was (b)(6) 2012.There was no pre-existing infection.The patient's leg is currently intact.

Manufacturer Narrative

H.6.Results code 1: 213: a review of the manufacturing records indicated the devices met pre-release specifications.A review of the sterilization records confirmed that all lots met all pre-release sterilization specifications.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8057389
• MDR Text Key: 126889726
• Report Number: 2017233-2018-00672
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Catalogue Number: PAH101002
• Device Lot Number: 8942360
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 106