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U.S. Department of Health and Human Services

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

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W. L. GORE & ASSOCIATES, INC. GORE® INTRODUCER SHEATH WITH SILICONE PINCH VALVE INTRODUCER, CATHETER Back to Search Results
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.
 
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Brand NameGORE® INTRODUCER SHEATH WITH SILICONE PINCH VALVE
Type of DeviceINTRODUCER, 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 Key14645238
MDR Text Key294842765
Report Number2017233-2022-03001
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K032073
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
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
Date FDA Received06/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2014
Device Catalogue NumberTS2030
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/06/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/09/2011
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/09/2022 Patient Sequence Number: 1
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