Catalog Number SE-06-100-120-6F |
Device Problem
Inaccurate Delivery (2339)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/07/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.
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Event Description
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It was reported that the procedure was to treat a mildly tortuous de novo mid femoral artery.The vessel size was checked, however, the size was misjudged and when deploying a 6.0 x 100 mm supera self-expanding stent system, the stent was too small to fully appose to the vessel wall and during deployment the stent moved, so the device was removed and the patient was sent to surgery.There was no clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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(b)(4).Evaluation summary: visual and functional inspections were performed on the returned device.The reported difficulty was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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Event Description
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Subsequent to the initial report: returned device analysis revealed the stent partially deployed and was removed from the anatomy with the delivery system.
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Search Alerts/Recalls
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