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U.S. Department of Health and Human Services

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

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W. L. GORE & ASSOCIATES, INC. CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT Back to Search Results
Catalog Number TGU312610J
Device Problem Patient-Device Incompatibility (2682)
Event Date 11/14/2015
Event Type  Injury  
Manufacturer Narrative
H3: code "other" was selected as the medical device remains implanted.Return not possible.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 information was reported to gore: on (b)(6) 2015, this patient underwent endovascular treatment for a thoracic type b dissection using conformable gore® tag® thoracic endoprostheses.An angiography determined the proximal type i endoleak after deployment.As it was a small amount, no further treatment was given.The patient was placed under observation.On an unknown date, a follow-up ct determined an enlargement of the thoracic aortic aneurysm.Embolization was performed using nbca.On an unknown date, an additional procedure was planned due to an aneurysm enlargement of the distal side of the device and a distal type i endoleak.On (b)(6) 2024, the patient underwent reintervention for an aneurysm enlargement and a distal type i endoleak using gore® tag® conformable thoracic stent graft with active control system.After deployment, the proximal side of the device appeared to be distorted when they adjusted the angulation control.Additional stent grafts were implanted on the proximal side as a treatment.Physician¿s comment: i tried to move the device (tgmr313115j) distally to fit it under curvature by angulation control, but it was placed in an unexpected position.
 
Manufacturer Narrative
H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.Emdr section h6, codes b14, c19, d12, d15 updated to reflect results of investigation.H6: code d12: according to the conformable gore® tag®thoracic endoprosthesis instructions for use, adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to: endoleak, aortic expansion (e.G., aneurysm, false lumen, landing zone, lesion).
 
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Brand Name
CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS
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
eimi ueda
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key19170710
MDR Text Key340897638
Report Number2017233-2024-04863
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,Followup
Report Date 05/23/2024
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 Expiration Date09/16/2018
Device Catalogue NumberTGU312610J
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/30/2024
Initial Date FDA Received04/24/2024
Supplement Dates Manufacturer Received03/30/2024
Supplement Dates FDA Received05/22/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/17/2015
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) Required Intervention;
Patient Age82 YR
Patient SexFemale
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