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

Catalog Number HT066080

Device Problems Complete Blockage (1094); Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Ischemia (1942); Pseudoaneurysm (2605); Thrombosis/Thrombus (4440)

Event Date 03/09/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

In 2012 the patient was diagnosed with peripheripheral vascular disease (pad).Previous surgery and intervention included stenting of the left popliteal artery and of the left superficial femoral artery in 2012.On (b)(6) 2015, the patient presented with ischemic rest pain (rutherford category 4, fontaine stage iii) of the left leg.Duplex ultrasound imaging revealed stenosis of the left popliteal artery.On (b)(6) 2015, the patient underwent open surgery to bypass the lesion with a gore® propaten® vascular graft.The distal anastomosis was place at the popliteal artery below the knee, the proximal anastomosis was place at the high popliteal artery (segment p1).During this intervention also percutaneous transluminal angioplasties (pta) were performed at the tibial artery and the peroneal artery to treat further stenosis.In addition, an in-stent pta was performed in the stent placed in the left superficial femoral artery in 2012.On (b)(6) 2016, the patient presented with claudication due to a septic false aneurysm, thrombosis within the graft and at its proximal anastomosis, requiring reintervention.On (b)(6) 2016, the patient underwent an open repair to treat the septic lesion in situ.The graft was explanted during this surgery.The database indicates that blood flow was established to the lower leg (procedure not specified).The patient recovered uneventful.On (b)(6) 2016, the septic lesion was resolved, and the patient was discharged to home.

Event Description

In 2012 the patient was diagnosed with peripheripheral vascular disease (pad).Previous surgery and intervention included stenting of the left popliteal artery and of the left superficial femoral artery in 2012.On (b)(6) 2015, the patient presented with ischemic rest pain (rutherford category 4, fontaine stage iii) of the left leg.Duplex ultrasound imaging revealed stenosis of the left popliteal artery.On (b)(6) 2015, the patient underwent open surgery to bypass the lesion with a gore® propaten® vascular graft.The distal anastomosis was place at the popliteal artery below the knee, the proximal anastomosis was place at the high popliteal artery (segment p1).During this intervention also percutaneous transluminal angioplasties (pta) were performed at the tibial artery and the peroneal artery to treat further stenosis.In addition, an in-stent pta was performed in the stent placed in the left superficial femoral artery in 2012.It was reported that there was no pre-existing infection in the field of treatment.However, reportedly, the patient had history of infectious lung disease, in (b)(6) 2015 and skin infection (not further specified).On (b)(6) 2016, the patient presented with claudication due to thrombosis within the graft and at its proximal anastomosis.During the examination a septic false aneurysm was diagnosed that required reintervention.It was reported that the septic infection of the false aneurysm was secondary to an infection of the gore graft.Reportedly, this infection has caused the septic false aneurysm.The next day, on (b)(6) 2016, the patient underwent an open repair to treat the septic lesion in situ.The graft was explanted during this surgery.To establish blood flow to the lower leg they performed a contralateral reverse saphenous vein bypass from the left superficial femoral artery to the popliteal artery just proximal to the bifurcation of the anterior tibial artery.Intraoperative sampling of the explanted graft and affected tissue showed staphylococcus aureus and escherichia coli.The patient recovered uneventful.On (b)(6) 2016, the septic lesion was resolved, and the patient was discharged to home.Reportedly, the physician suspects that the sepsis was potentially caused by pulmonary and cutaneous germs during implantation of the prosthesis on (b)(6) 2015.

Manufacturer Narrative

Cause investigation and conclusion: the product itself was not returned for evaluation.Instead, the explanted graft was discarded at the facility.Based on the updated event description there was no malfunction of the graft.Furthermore, there is no indication that the graft has caused or contributed to the onset infection.Instead, it was reported, that the physician stated that the patient had history of infectious lung disease, in (b)(6) 2015 and skin infection (not further specified).Therefore, the physician suspects that the sepsis was potentially caused by pulmonary and cutaneous germs during implantation of the gore® propaten® vascular graft on (b)(6) 2015.These germs may have caused graft infection which reportedly has caused the septic false aneurysm requiring explantation of the graft.In the instructions for use the following is stated: possible complications with the use of any vascular prosthesis.Complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to: infection; thrombosis.

Manufacturer Narrative

H6: code b11: similar events have been evaluated and trend analysis was performed.Considering the nature of this event and the results of this investigation, this occurrence did not warrant corrective or preventative action.H6: code 18: the product itself was not returned for evaluation.Instead, the explanted graft was discarded at the facility.

• Brand Name: GORE® PROPATEN® VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15956143
• MDR Text Key: 305428053
• Report Number: 2017233-2022-03564
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2023

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: 03/13/2019
• Device Catalogue Number: HT066080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 12/10/2022
• Supplement Dates Manufacturer Received: 01/18/2023; 03/08/2023
• Supplement Dates FDA Received: 02/20/2023; 03/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male