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

Model Number SB1801D

Device Problem Partial Blockage (1065)

Patient Problem Stenosis (2263)

Event Date 09/08/2016

Event Type  Injury  

Manufacturer Narrative

Code b20: the device remains implanted in the patient.Therefore a device evaluation could not be performed.Code 21: preliminary results or conclusions are not yet available because investigation is still ongoing.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

Subject: 2101-760-011 ae id: 1 ae term: isolated ectatic dissection of right external iliac artery with estimated stenosis of 70%, probably related to cross-clamping lesion during surgery of (b)(6) 2016, treated by pta with stenting (b)(6) 2017.Onset date: (b)(6) 2016.Relationship: registry procedure-related on (b)(6) 2016, the patient underwent an endovascular repair of a abdominal aortic aneurysm which was treated with a gore-tex® vascular graft.The device was implanted and retained during this procedure.Reportedly on (b)(6) 2016 an adverse event termed "ectatic dissection of the right external iliac artery with 70% estimated stenosis" was discovered.According to report the adverse event was probably related to cross-clamping lesion during the surgery on (b)(6) 2016.Reportedly, it was treated by pta with stenting on (b)(6) 2017.Reportedly, the adverse event resolved without sequelae.The reintervention was planned and device patency was reportedly restored.The patient was discharged on (b)(6) 2017.

Manufacturer Narrative

G3/g4: corrected pma/510(k)number.

Manufacturer Narrative

H6: corrected imdrf codes.

• Brand Name: GORE-TEX® STRETCH 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: wilson okeke ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15368311
• MDR Text Key: 299358302
• Report Number: 2017233-2022-03295
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132611843
• UDI-Public: 00733132611843
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K904282
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2021
• Device Model Number: SB1801D
• Device Catalogue Number: SB1801D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2016
• 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): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male