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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Code Available (3191)

Event Date 09/22/2017

Event Type  Injury  

Manufacturer Narrative

The following literature article was reviewed: "comparison of endovascular versus bypass surgery in femoro-popliteal tasc ii d lesions: a single-centre study" gian franco veraldi et al.Annals of vascular surgery accepted sep 14, 2017; published online sep 22, 2017.Https://doi.Org/10.1016/j.Avsg.2017.09.008, ann vasc surg 2018;47:179-187.Date of implant remains unknown.Date of the event remains unknown, so the date the literature was published was used.Patient age: mean age 72 years.Patient gender: vast majority is male.The information available relating to the reported event is not sufficient to identify the device, because the lot number has not been provided.The lot number was requested.The device remains implanted, so an engineering evaluation could not be performed.Additional requests were sent to the author to provide patient date of birth, age, identifier, weight, gender; date of initial procedure, date of diagnose of anastomotic pseudoaneurysm; description of related procedures; dicom imaging series showing the anastomotic pseudoaneurysm.

Event Description

The following literature article was reviewed: "comparison of endovascular versus bypass surgery in femoro-popliteal tasc ii d lesions: a single-centre study" gian franco veraldi et al.Annals of vascular surgery accepted sep 14, 2017; published online sep 22, 2017.Https://doi.Org/10.1016/j.Avsg.2017.09.008 ann vasc surg 2018;47:179-187.Eighty limbs with symptomatic severe occlusive disease (tasc ii d) of the femoro-popliteal segment observed from january 2013 to january 2017 were included in this retrospective study.Indication to treatment was severe claudication in 17 limbs and critical limb ischemia (cli) in 63 limbs.As to the run-off, all limbs included had at least one vessel patent up to the distal third of the leg.Of these limbs, 40 were treated by means of percutaneous transluminal angioplasty (pta) plus bare metal stent (bms) (group a) and 40 were treated by means of femoro-popliteal bypass with gore® propaten® vascular graft (6 mm and 7 mm diameter) plus linton patch with biologic material (either autologous vein or cryopreserved vein homograft in case of unavailable autologous vein) tailored to the distal anastomosis (group b).Patency, re-intervention rate and limb salvage were compared in the two groups.Patients were followed with a clinical assessment and duplex at 1, 6, 12 months after procedure and then annually.A closer follow up was performed in case of any complication.In the article the following complication greater than 30 days after surgery in group b was reported: one patient underwent surgical correction of a proximal anastomotic aneurysm.

Manufacturer Narrative

H6-code 3221: the corresponding author replied, that "is was an old database, dating more than 4 years ago and also anonymized, and it is impossible to resume clinical data of those patients from our archive." the lot numbers remain unknown.Without additional information, gore was unable to do further investigation of this event.

Manufacturer Narrative

Additional manufacturer narrative: c1.Name (b)(6) ; 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: 10085034
• MDR Text Key: 197165321
• Report Number: 2017233-2020-00385
• 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,Followup
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2020
• 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: 72 YR