Model Number 1010880 |
Device Problem
Infusion or Flow Problem (2964)
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Patient Problem
Stenosis (2263)
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Event Date 11/17/2021 |
Event Type
Injury
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Manufacturer Narrative
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No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed. .
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Event Description
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It was reported that on (b)(6) 2021, since stenosis on the v side was suspected, angiography was performed, and the luminal part of the artificial blood vessel was concave, and dissociation was confirmed.On (b)(6) 2021, the suspected dissociation was removed and replaced with a thoratec graft.
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Manufacturer Narrative
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No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed. .
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Event Description
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It was reported that on (b)(6) 2021, since stenosis on the v side was suspected, angiography was performed, and the luminal part of the artificial blood vessel was concave, and dissociation was confirmed.On (b)(6) 2021, the suspected dissociation was removed and replaced with a thoratec graft.
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Manufacturer Narrative
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Section e: this event occurred at (b)(6) hospital in (b)(6).Manufacturer's investigation conclusion: the report of stenosis and dissociation of the graft layers could not be confirmed.The customer reported that an angiography was performed on (b)(6) 2021 due to suspicion of graft stenosis.The luminal side of the graft was reported to be concave and there was believed to be a dissociation.The suspected dissociation was removed and replaced with a new graft on (b)(6) 2021.The replaced section of graft was reportedly disposed of and no product is available for investigation.The cause of the reported stenosis and graft issue could not be determined.Review of the device history records showed no deviations from manufacturing or quality assurance specifications, including visual and dimensional inspection.Graft preparation and implantation are addressed in the vectra vascular access graft (vag) instructions for use (ifu).Occlusion, stenosis, and thrombosis are listed as potential complications with the use of a vascular prosthesis.Intragraft obstruction is listed as a potential complication in table 2 in the summary of vectra vag clinical experience section of the ifu.The ifu states that the graft should not be pulled (axially elongated) or stretched during handling at implantation.The graft should be trimmed long enough to prevent stress on the anastomosis and allow for a full range of body motion when implanted.Excessive elongation or stretching of the graft will damage the microporous layers of the graft.No further information was provided.The manufacturer is closing the file on this event.
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Event Description
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The cause of the obstruction was seemingly the peeling of the inner layer.The patient was stable and there were no plans for future care.
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Search Alerts/Recalls
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