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U.S. Department of Health and Human Services

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

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W. L. GORE & ASSOCIATES, INC. GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT Back to Search Results
Catalog Number TAC083715A
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Stroke/CVA (1770)
Event Date 01/12/2024
Event Type  Death  
Event Description
Fsa called and reported the following: on (b)(6) 2023, the patient underwent a thoracic endovascular procedure to treat an aortic intramural hematoma (imh) that involved the descending thoracic aorta and left subclavian artery.The gore® tag® thoracic branch endoprosthesis (tac083715a, tsb081206a) was utilized in zone 2 to treat this patient.Ct scans showed that the aorta was diseased around the left subclavian artery.The physician decided to land a portion of the tbe aortic component in proximal landing zone, within the diseased tissue.Patient tolerated the procedure.On (b)(6) 2023, the physician called the fsa and reported that the patient developed an ascending imh which she believes caused a stroke and resulted in patient death.Physician believes there may have been thrombus present in the ascending aorta although it was not detectable on ct scan.Physician also speculated that it's possible the ascending imh was induced by the proximal end of the tac083715a since it was landed in diseased tissue.No further patient information is available.No patient images are available.Code 1003-e:-none used to capture no device issue was identified.
 
Manufacturer Narrative
As it is unknown which device is directly implicated in this death event, the following device will also be included in this report: catalog #tsb081206a/ serial (b)(6)/ udi (b)(4).H6: code c21 - results pending completion of product history review.H6: code c20 - the device remains implanted and, therefore, was not available for engineering analysis by gore.According to the gore® tag® thoracic branch endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to, neurologic damage, local or systemic-stroke and death.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
As it is unknown which device is directly implicated in this death event, the following device will also be included in this report: catalog#: tsb081206a / serial#: (b)(6) / udi#: (b)(4).H6: code c19-a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.As the device was not accessible, the product history review (phr) review was the extend of the investigation.No device problem was found per review of these records.
 
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Brand Name
GORE® TAG® THORACIC BRANCH 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
lillian espinoza
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key18670972
MDR Text Key334921890
Report Number2017233-2024-04611
Device Sequence Number1
Product Code MIH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P210032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/15/2024
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 NumberTAC083715A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/12/2024
Initial Date FDA Received02/08/2024
Supplement Dates Manufacturer Received02/15/2024
Supplement Dates FDA Received02/15/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/19/2023
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) Death;
Patient Age66 YR
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