Catalog Number 1012623-19 |
Device Problems
Device Damaged by Another Device (2915); Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/30/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(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 relevant information.The 6.0 mm x 19 mm x 80 cm omnilink elite referenced is being filed under separate medwatch report.
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Event Description
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It was reported the procedure was to treat a lesion in the celiac and superior mesenteric arterial (sma) trunk.The 7.0 mm x 19 mm x 80 cm omnilink elite stent was successfully deployed in the celiac trunk without issue.A 6.0 mm x 19 mm x 80 cm omnilink elite balloon expandable stent system was inserted in the sma, however during insertion in the sma the second omnilink stent strut got caught on the deployed stent.It would not become untangled with catheter maneuvers or inflation.The 6.0 mm x 19 mm x 80 cm omnilink stent had to be deployed inside of the guide catheter to try to get it to untangle from the strut of the previously placed stent, however this did not work, both stents remained attached.The guiding catheter was removed with the 6.0 mm x 19 mm x 80 cm omnilink stent inside of it.As the guide catheter was removed, the 7.0 mm x 19 mm x 80 cm omnilink stent in the celiac trunk became mangled and was explanted as it was still entangled with the omnilink stent inside the guide catheter.The procedure was discontinued.There were no adverse patient effects.Although there was a delay in the procedure it did not result in significant impact to the patient.The patient will have to return for angioplasty and stenting.No additional information was provided.
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Manufacturer Narrative
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(b)(4).Evaluation summary: visual inspections were performed on the returned device.The stent damage was confirmed.It is likely that the reported difficulties occurred due to interaction with the previously deployed stent.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 other incidents from this lot.The investigation determined that the reported difficulty was due to operational context.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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Search Alerts/Recalls
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