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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

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W. L. GORE & ASSOCIATES, INC. GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT Back to Search Results
Catalog Number TGMR313110J
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Paralysis (1997)
Event Date 01/10/2024
Event Type  Injury  
Event Description
On (b)(6) 2024, this patient underwent an emergent endovascular treatment of a descending aorta aneurysm rupture using gore® tag® conformable thoracic stent graft with active control system(ctag/ac).Reportedly, the procedure went well with all devices being implanted with no issues and patient tolerated the procedure.On (b)(6) 2024, it was reported that the patient developed paraplegia(detailed onset date unknown).It was also reported that the details of the treatment is unknown, but some kind of treatment was taken after onset and the patient is being monitored.
 
Manufacturer Narrative
H3: code "other" was selected as the medical device remains implanted.Return not possible.H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H6: code d12: according to the gore® tag® conformable thoracic stent graft with active control system instructions for use, adverse events which may require intervention and/or conversion to open repair include, but are not limited to: paraplegia.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 Name
GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
Type of Device
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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
hiroko sakamiya
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key18628743
MDR Text Key334368578
Report Number2017233-2024-04588
Device Sequence Number1
Product Code MIH
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P040043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 02/02/2024
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 Catalogue NumberTGMR313110J
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/10/2024
Initial Date FDA Received02/01/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/19/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age87 YR
Patient SexMale
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