Catalog Number 1070350-33 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Vascular Dissection (3160)
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Event Date 11/29/2021 |
Event Type
Injury
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Event Description
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It was reported that on (b)(6) 2021, the patient presented with angina, and a percutaneous coronary intervention was performed on the proximal left anterior descending (lad) coronary artery, 100% occluded lesion.Pre-dilatation was performed and a 3.5x33mm xience xpedition stent was implanted without a device issue reported.Following and per fluoroscopy, a distal edge, xience xpedition stent dissection was observed.As treatment, another xience xpedition stent was implanted without further issues reported.There was no adverse patient sequela and no clinically significant delay.No additional information was provided regarding this issue.
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Manufacturer Narrative
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The stent remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Manufacturer Narrative
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The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued that would have contributed to this event.The reported patient effect of dissection is listed in the xience xpedition everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.E1: physician name.
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Search Alerts/Recalls
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