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

Device Problem Microbial Contamination of Device (2303)

Patient Problem Unspecified Infection (1930)

Event Date 03/10/2019

Event Type  Injury  

Manufacturer Narrative

The section for patient information were completed with the provided mean age and mean gender of the article.The date of event section was completed with the date when the article was accepted as individual date of event was not stated in article.Prevalence and risk factors for heparin-bonded expanded polytetrafluoroethylene vascular graft infection after infrainguinal femoropopliteal bypasses¿, published by gabriele piffaretti et al, within the journal of vascular surgery.

Event Description

Within the article ¿prevalence and risk factors for heparin-bonded expanded polytetrafluoroethylene vascular graft infection after infrainguinal femoropopliteal bypasses¿, published by gabriele piffaretti et al, within the journal of vascular surgery, the article indicates the following: the multicenter study retrospectively evaluated prosthetic vascular graft infection (pvgi) that developed after infrainguinal revascularization (femoropopliteal bypasses) performed with a heparin-bonded expanded polytetrafluoroethylene graft (gore propaten graft) that was used in 1400 interventions between 2002 and 2016.Critical limb ischemia (cli) was the main indication for bypass (65%).A prosthetic graft with infection was defined as direct involvement of the graft with positive bacterial cultures of graft or perigraft material, intraoperative gross purulence or failure of graft incorporation, or exposed graft in an infected wound.A total of 33 heparin-bonded expanded polytetrafluoroethylene grafts (2.3%) became infected; the median time to occurrence was 5 months.The infected graft was explanted in all patients.Eleven patients (33%) underwent redo bk revascularization with autologous gsv or cryopreserved human allograft.Fifteen patients (45%) did not undergo revascularization, either because they were asymptomatic or owing to the absence of adequate distal target vessel.Seven patients (21%) underwent major amputation because the limb was not salvageable secondary to the extent of infection.Five patients required major amputation, because of severe ischemia or ascending lower limb infection.The early (<30 days) mortality of operative management of pvgi was 12%, with causes of death being sepsis for 3 patients.All patients with a clinical suspicion of pvgi were evaluated with full panel blood tests, including inflammatory markers, bloodstream and urinary tract cultures, and computed tomography angiography.An infectious disease physician specialist evaluated each patient at admission and regularly during the entire hospitalization to optimize the type, dosage, and duration of antibiotic therapy.

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 PROPATEN VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10127020
• MDR Text Key: 194302682
• Report Number: 2017233-2020-00406
• 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: 09/01/2020

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: 06/08/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other; Required Intervention
• Patient Age: 72 YR