MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE PROPATEN VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Information (3190)

Event Date 10/02/2018

Event Type  Injury  

Manufacturer Narrative

The reviewed literature, attached, includes reportable events processed with gore event numbers 42259, 42260, 42261 and 42263.Therefore four medwatch reports were transmitted related to this literature.Patient age and gender provided in the article: patient age: 70 = mean age; patient gender: vast majority is male.Section b: date of event is unknown, so the date the manuscript was accepted was used as date of event.The lot numbers of the devices are requested.It is also requested if the devices are still implanted and thus not available for investigation.

Event Description

The following literature article was reviewed: "results of infrainguinal revascularization with bypass surgery using a heparin-bonded graft for disabling intermittent claudication due to femoropopliteal occlusive disease" gabriele piffaretti et al.Journal of vascular surgery, 2019 jul;70(1):166-174.Accepted 2018 oct 2; epub 2019 may 18.The purpose of this retrospective multicentric registry study was to analyze the results of infrainguinal revascularization for disabling intermittent claudication (ic) due to femoropopliteal occlusive disease using bypass graft (bpg) surgery with a heparin bonded expanded polytetrafluoroethylene (hb-eptfe) graft.Between 2002 and 2016, we performed 1400 bpgs with hb-eptfe interventions in patients with femoropopliteal occlusive disease, of which ic was an indication in 485 patients.We performed 200 above-knee bpgs and 231 below-knee bpgs; 54 bpgs targeted a tibial artery, using an hb-eptfe graft (gore propaten, 6 mm in 306 patients, 7 mm in 61 patients, 8 mm in 118 patients).Levels of proximal anastomosis: external iliac artery (3), common femoral artery (431), superficial femoral artery (37), above knee popliteal artery (14).Levels of distal anastomosis: above knee popliteal artery (200), below knee popliteal artery (231), anterior tibial artery (5), posterior tibial artery (11), tibioperoneal trunk (35), peroneal artery (3).Interventions were performed in the operating room under general anesthesia, and surgical techniques conformed to standard principles.Individualized procedures have been left to the surgeon¿s judgment.Estimated primary patency of the bpg was 86.1% at 12 months, 68.4% at 36 months, and 57.7% at 60 months.Estimated freedom from redo bypass was 96.1% at 12 months, 84.8 at 36 months, and 76.4 at 60 months.The article includes the following cases: prosthetic graft infection occurred in seven patients, with a delay from index procedure to presentation with graft infection of 1-72 month.

Manufacturer Narrative

H6-code 3221: lot/serial numbers were requested but not disclosed, therefore, a review of the manufacturing records could not be conducted.It could not be clarified if the devices were still implanted or if explanted devices were available for investigation, if applicable.The information was not disclosed.Therefore no investigation can be performed and therefore no results can be obtained.

• Brand Name: GORE PROPATEN VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9105788
• MDR Text Key: 163026687
• Report Number: 2017233-2019-00883
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 70 YR