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

Catalog Number H060040

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Stenosis (2263)

Event Date 10/30/2012

Event Type  Injury  

Manufacturer Narrative

No patient specific details have been provided.Therefore, the patient identifier reflect the study no.With hospital and patient.A product history review will be performed.As the device remains implanted, a further investigation cannot be performed.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

The following was reported to gore from a retrospective study: on (b)(6) 2012, the patient underwent surgical treatment for the creation of a lower extremity vascular access graft in the proximal third of the superficial femoral artery for hemodialysis with a gore® propaten® vascular graft.The device was implanted and retained and successfully used on (b)(6) 2012.On (b)(6) 2012, there was a stenosis in the femoral artery proximal to the graft anastomosis, which caused clinical leg ischemia and low graft flows after implantation.According to the physician the cause of the stenosis was due to chronic arteriosclerosis.The same day an endovascular repeat intervention, namely an angioplasty and placement of a cook medical zilver® ptx® 7 x 40 mm stent was performed to solve the stenosis.

Manufacturer Narrative

Product history review: a review of the manufacturing- and heparin coating records indicated the lots met all pre-release specifications.As the device remains implanted, no further investigation of the device can be conducted.No clinical images enable direct assessment of product performance were returned for evaluation.According to the physician the cause of the stenosis was due to chronic arteriosclerosis.With the information provided to gore, the cause of the reported event cannot be established.In the instruction for use for the gore® propaten® vascular graft the following was stated: adverse events: potential device or procedure-related adverse events: complications which may occur in conjunction with the use of any vascular prosthesis and/or vascular or related procedures include but are not limited to: partial or complete occlusion due to hemodynamically significant stenosis or thrombosis.

Manufacturer Narrative

Arterial stenosis due to patient¿s chronic arteriosclerosis at a location proximal to and not including an implanted graft is not a device related adverse event.This event is not considered reportable and is therefore being retracted.

• 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: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16333637
• MDR Text Key: 309130266
• Report Number: 2017233-2023-03704
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: SP
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: H060040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2012
• 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
• Treatment: COOK MEDICAL ZILVER® PTX® 7 X 40 MM DRUG ELUTING P
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male