Catalog Number 1550275-38 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
Occlusion (1984)
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Event Date 04/05/2019 |
Event Type
Injury
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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 stent remains in the patient.Investigation is not yet complete.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 this was a percutaneous intervention for a proximal circumflex (cx) lesion with in-stent restenosis.Following pre-dilatation, a 2.75x38mm xience sierra stent was implanted.Post implantation, stent under expansion was observed.The proximal and distal half of the stent was tapered, with a distal reference minimal luminal area (mla) <4.5mm.In addition, intra-stent plaque protrusion or thrombus was also reported.As treatment, the maximum size post-dilatation balloon was used.There was no adverse patient sequela reported.No additional information was provided regarding this issue.
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Manufacturer Narrative
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(b)(4).The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulty to deploy (wall apposition).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 medwatch report, the additional information was received: there was no plaque or thrombus in the 2.75x38mm xience sierra stent.
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Search Alerts/Recalls
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