Model Number GELSOFT PLUS BIFURCATE |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
Aneurysm (1708)
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Event Date 01/05/2024 |
Event Type
Injury
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Manufacturer Narrative
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Manufacturers narrative: health effect: 1708 - aneurysm: on (b)(6) 2023, blood leakage was observed from the bifurcation of the graft, causing the aneurysm to enlarge.Impact code: 4625 - additional surgery was performed.4624 - surgical intervention - further surgery was needed to remove device.4627 - device explanation - device was implanted on (b)(6) 2011, device was explanted on (b)(6) 2024 and is being returned for investigation.4642 - additional device was required - a vascular graft was implanted on (b)(6) 2024.Medical device problem code: 2978 - material integrity problem - bifurcate was explanted and a hole was found at the bifurcation of the graft.Component code: 4755 - part / component/ sub-assembly code not applicable - this device has no component parts.
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Event Description
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The patient underwent the procedure with the gelsoft plus (so-631206p, 12mm x 6mm) for aaa on (b)(6) 2011 and there were no problems after the procedure.On (b)(6) 2023, blood leakage was observed from the bifurcation of the graft, causing the aneurysm to enlarge.Ivr treatment was considered, but the left branch of the graft was stenosed, and the patient underwent open surgery on (b)(6) 2024.The implanted graft was removed, and a hole was found at the bifurcation of the graft.Surgery was performed with a vascular graft (manufacturer and specifications unknown) and was successfully completed.
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Manufacturer Narrative
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Manufacturers narrative: health effect:- 1708 - aneurysm - in (b)(6) 2023, blood leakage was observed from the bifurcation of the graft, causing the aneurysm to enlarge.Impact code:- 4625 - additional surgery was performed.4624 - surgical intervention - further surgery was needed to remove device.4627 - device explanation - device was implanted on (b)(6) 2011, device was explanted on (b)(6) 2024 and is being returned for investigation.4642 - additional device was required - a vascular graft was implanted on (b)(6) 2024.Medical device problem code:- 2978 - material integrity problem - bifurcate was explanted and a hole was found at the bifurcation of the graft.Component code:- 4755 - part / component/ sub-assembly code not applicable - this device has no component parts.Type of investigation:- 4110 - trend analysis: a similar event review was performed for leakage > blood oozing > bifurcation events with gelsoft plus grafts between (b)(6) 2019 and (b)(6) 2024.A similar event rate of 0.001% was confirmed.No negative trend was identified.4111 - communication/ interview: further information was requested from the site regarding issues noticed during implantation.No additional information was available due to the time passed since implantation operation.3331- analysis of production records: full batch review was performed and showed no issues with the device during manufacturing from raw material to finished product.10 - testing of the actual device: the relevent section of the device was returned for inspection.Investigation findings: 4210 - leakage / seal: microscopic analysis of the returned section of the device identified a small hole at the bifurcation point of the graft.Due to the leakage being identified 13 years after implantation the cause of this hole could not be confirmed.Investigation conclusion: 4315 - cause not established: from the investigation completed, information received and returned device analysis, the cause of the small hole identified could not be confirmed.
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Event Description
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The patient underwent the procedure with the gelsoft plus (so-631206p, 12mm x 6mm) for aaa on (b)(6) 2011 and there were no problems after the procedure.In december 2023, blood leakage was observed from the bifurcation of the graft, causing the aneurysm to enlarge.Ivr treatment was considered, but the left branch of the graft was stenosed, and the patient underwent open surgery on (b)(6) 2024.The implanted graft was removed, and a hole was found at the bifurcation of the graft.Surgery was performed with a vascular graft (manufacturer and specifications unknown) and was successfully completed.This report has been submitted as a final for mfg.Report fda 9612515-2024-00006 to provide investigation details and outcome.
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Search Alerts/Recalls
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