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Catalog Number BCL2645J |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Vascular Dissection (3160)
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Event Date 07/14/2021 |
Event Type
Injury
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Manufacturer Narrative
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Medical device was discarded at facility.Return not possible.(b)(4).Use of an additional or alternative device was required to achieve optimal outcome.Additional stent grafts were implanted.An adverse event (e.G.Patient harm) appears to have occurred, but there does not appear to have been a problem with the device or the way it was used.The investigation involved the analysis of relevant production records in view of supporting the identification of possible causes for the adverse event.The investigation involved communication/interviews (either interpersonal or through technical means, e.G.Phone, e-mail) with persons close to the adverse event, e.G.Healthcare professionals (doctors, nurses etc.), the affected patient(s) or other users including, where appropriate, relatives or others engaged in caring for the affected patient.The actual device involved in the adverse event was not returned for testing despite requests by manufacturer.Medical device was discarded at facility.Investigation is ongoing, and results are not yet available.(do not use this code if the investigation is complete).The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.
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Event Description
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The following information was reported to gore: on (b)(6) 2021, this patient underwent endovascular treatment of a traumatic aortic injury with type b aortic dissection using gore® tag® conformable thoracic stent graft with active control system.After implantation of ctagac, balloon touch-up was performed by using gore® tri-lobe balloon catheter to treat an endoleak and the procedure was completed.On (b)(6) 2021, the patient was transported to emergency due to chest pain.Stent graft induced new entry (sine) was detected in both proximal and distal sides.On (b)(6) 2021, a reintervention took place whereby additional stent grafts were implanted, proximally and distally.Reportedly it was most likely a case of traumatic aortic injury with type b aortic dissection based on ct data review.
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Manufacturer Narrative
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H3: code "other" was selected as the medical device was discarded at facility.Return not possible.H6: code 4614 ¿ a severe injury, illness or impairment which requires hospitalization or medical intervention.H6: code 4642 ¿ use of an additional or alternative device was required to achieve optimal outcome.Additional stent grafts were implanted.H6: code 2993 ¿ an adverse event (e.G.Patient harm) appears to have occurred, but there does not appear to have been a problem with the device or the way it was used.H6: code 3331 ¿ the investigation involved the analysis of relevant production records in view of supporting the identification of possible causes for the adverse event.H6: code 4111 ¿ the investigation involved communication/interviews (either interpersonal or through technical means, e.G.Phone, e-mail) with persons close to the adverse event, e.G.Healthcare professionals (doctors, nurses etc.), the affected patient(s) or other users including, where appropriate, relatives or others engaged in caring for the affected patient.H6: code 4114 ¿ the actual device involved in the adverse event was not returned for testing despite requests by manufacturer.Medical device was discarded at facility.H6: code 213 ¿ the device either functioned as intended or a problem was not found.H6: code 4315 ¿ the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.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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Search Alerts/Recalls
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