MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® INTRODUCER SHEATH WITH SILICONE PINCH VALVE; INTRODUCER, CATHETER

Catalog Number TS2030

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation of Vessels (2135); Obstruction/Occlusion (2422)

Event Date 12/19/2011

Event Type  Injury  

Event Description

On (b)(6) 2011, the patient underwent endovascular treatment of a descending thoracic aorta aneurysm using a gore® tag® thoracic endoprosthesis, and a 20fr gore® introducer sheath with silicone pinch valve as an accessory during the procedure.After successful implantation of the gore® tag® device, it was reported the right common iliac artery was injured upon removing the sheath.Four additional stent grafts were placed as treatment, extending distally into the external iliac artery.The patient tolerated the procedure.The root cause of the iliac artery rupture was not available.The vessel reportedly measured approximately 5.5 ¿ 7.6mm in diameter in the region of injury (within recommended sizing guidelines in instructions for use).No notable anatomical issues (calcium, tortuosity, etc.) were reported.

Manufacturer Narrative

(b)(4).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.

Manufacturer Narrative

H6: code c19 ¿ a review of the manufacturing records for the device verified that the lot met all pre-release specifications.

Manufacturer Narrative

H6: updated component code.

• Brand Name: GORE® INTRODUCER SHEATH WITH SILICONE PINCH VALVE
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: damon jackson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14645238
• MDR Text Key: 294842765
• Report Number: 2017233-2022-03001
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K032073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/12/2022

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: 02/28/2014
• Device Catalogue Number: TS2030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2022
• Initial Date FDA Received: 06/09/2022
• Supplement Dates Manufacturer Received: 08/19/2022; 10/06/2022; 10/06/2022
• Supplement Dates FDA Received: 08/19/2022; 10/12/2022; 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male