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

Device Problem Complete Blockage (1094)

Patient Problems No Consequences Or Impact To Patient (2199); Claudication (2550)

Event Date 01/28/2015

Event Type  Injury  

Manufacturer Narrative

Lot/serial numbers were not provided, therefore, a review of the manufacturing records could not be conducted.[(b)(4)].

Event Description

The following publication was reviewed: ¿safety and efficacy of using the viabahn endoprosthesis for percutaneous treatment of vascular access complications after transfemoral aortic valve implantation¿ (ole de backer et al., the american journal of cardiology, accepted january 28, 2015).Over a 40-month period, a total of 380 patients underwent transcatheter aortic valve implantation (tavi) in a single-center using the self-expanding corevalve (medtronic, minneapolis, mn).Access-related complications (vac) leading to acute intervention occurred in 72 patients (20.3%) of the study population.Minor vascular injury at the puncture site was treated with either external compression or balloon angioplasty for 3 to 5 minutes.If this strategy failed or when major extravasation was apparent on angiographic control, a 50-mm-long gore® viabahn® endoprostheses (vb) was inserted covering the vessel lesion, aiming to place the distal part of the stent proximal to the bifurcation of the common femoral artery (cfa) into superficial femoral artery (sfa) and deep femoral artery (dfa).Vb were used for different types of vac: stenosis (n=3), dissection (n=4), incomplete vascular closure due to closure device failure (n=36), and rupture/perforation (n=5).The use of vb was the primary choice in 38 patients, whereas in 10 other patients, stenting was preceded by balloon angioplasty with unsatisfactory result.Follow-up data on the vb subgroup were obtained in 44 of 48 patients (median follow-up time: 372 days).It was stated that the vb was covering the dfa in 3 patients, which resulted in new-onset claudication in one of these patients, whereas 2 others remained asymptomatic.

Manufacturer Narrative

Additional manufacturer narrative: c1.Name (#1) - cbas® heparin surface; - manufacturer/compounder: w.L.Gore & associates, inc.- lot #unknown - cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10024390
• MDR Text Key: 190137933
• Report Number: 2017233-2020-00318
• 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
• Type of Report: Initial,Followup
• Report Date: 09/04/2020

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR