MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE VIABAHN ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number PAH100502

Device Problem Migration (4003)

Patient Problem No Code Available (3191)

Event Date 12/31/2011

Event Type  Injury  

Manufacturer Narrative

The following literature article was reviewed: "maximising the patency of a popliteal endoprosthesis despite multiple challenges" arindam chaudhuri bedford hospital nhs trust, bedford, uk.European journal of vascular and endovascular surgery, ejves short reports (2020) 46, 1.Available online 3 january 2020.Https://doi.Org/10.1016/j.Ejvssr.2019.11.001.The literature reports two incidents - migration in 2011 and fracture in 2014 both requiring reintervention.The fracture was reported previously with mfr report # 2017233-2015-00031 (gore ref.Number # 24405).With the present report migration requiring reintervention is being reported.(b)(4).The device remains implanted, therefore no engineering evaluation could be performed.In 2014 and 2020 the author was contacted to provide additional information like serial number, patient date of birth and other relevant data.The answers were included in this report.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

The following literature article was reviewed: "maximising the patency of a popliteal endoprosthesis despite multiple challenges" arindam chaudhuri bedford hospital nhs trust, bedford, uk.European journal of vascular and endovascular surgery, ejves short reports (2020) 46, 1.Available online 3 january 2020.Https://doi.Org/10.1016/j.Ejvssr.2019.11.001.Case report an (b)(6) year old male presented eight years after left popliteal endovascular aneurysm repair (pevar) for a 58 mm popliteal artery aneurysm (paa) using 10 mm gore® viabahn® endoprostheses with propaten bioactive surface.He took up cycling after this, resulting in multiple redo pevar episodes: 2011: migration treated with stent graft extension.2014: fracture, relined, with eventual graft failure and fractures with no endoleak noted, diagnosed when he presented with left calf pain (deep vein thrombosis excluded).Throughout there was continued paa shrinkage (currently 47 mm).As there was now new paa formation distal to the distal landing zone of the stent graft, this was treated with a reversed great saphenous vein bypass graft which remains patent at six months.

Manufacturer Narrative

G1 correction: reporting contact last name.H6-code 213: a review of the manufacturing records indicate the lots met all pre-release specifications.

Manufacturer Narrative

Per instructions for use, w.L.Gore & associates has insufficient clinical and experimental data upon which to base any conclusions regarding the effectiveness of the devise in applications where the endoprosthesis may experience repeated and extreme flexion, such as across the popliteal fossa and the anticubital fossa.Clinical conditions such as excessive bending, tortuosity, and / or repeated and extreme flexion may result in compromised performance or failure of the endoprosthesis.

Event Description

The following literature article was reviewed: "maximising the patency of a popliteal endoprosthesis despite multiple challenges." arindam chaudhuri.Bedford hospital nhs trust, bedford, uk.European journal of vascular and endovascular surgery, ejves short reports (2020) 46, 1.Available online 3 january 2020.Https://doi.Org/10.1016/j.Ejvssr.2019.11.001.Case report: an 82 year old male presented eight years after left popliteal endovascular aneurysm repair (pevar) for a 58 mm popliteal artery aneurysm (paa) using 10 mm gore® viabahn® endoprostheses with propaten bioactive surface.He took up cycling after this, resulting in multiple redo pevar episodes: 2011: migration treated with stent graft extension.2014: fracture, relined, with eventual graft failure and fractures with no endoleak noted, diagnosed when he presented with left calf pain (deep vein thrombosis excluded).Throughout there was continued paa shrinkage (currently 47 mm).As there was now new paa formation distal to the distal landing zone of the stent graft, this was treated with a reversed great saphenous vein bypass graft which remains patent at six months.Additional information provided by the author: implant date: (b)(6) 2011.From a clinical standpoint the patient has done well.

Manufacturer Narrative

Updated section d and g: brand name, code, 510(k).

• Brand Name: GORE VIABAHN ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10396695
• MDR Text Key: 204341155
• Report Number: 2017233-2020-01115
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/23/2020

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
• Device Expiration Date: 10/31/2013
• Device Catalogue Number: PAH100502
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/13/2020
• Initial Date FDA Received: 08/12/2020
• Supplement Dates Manufacturer Received: 09/01/2020; 09/01/2020; 10/23/2020
• Supplement Dates FDA Received: 09/23/2020; 10/14/2020; 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 74 YR