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.
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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.
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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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