Model Number 1550300-33 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Angina (1710); Stenosis (2263); Vascular Dissection (3160)
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Event Date 08/17/2020 |
Event Type
Injury
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Manufacturer Narrative
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The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.It should be noted that the reported patient effects of angina, dissection and stenosis are listed in the xience sierra, everolimus eluting coronary stent system instructions for use as known patient effects 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.
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Event Description
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Patient id: (b)(6).It was reported that on (b)(6) 2020, the patient presented with in-stent restenosis in the proximal left anterior descending (lad) coronary artery with 70% stenosis.A cutting/scoring balloon prepped the lesion.Following, a 3.0x33mm xience sierra stent was implanted without a device malfunction reported.An edge dissection was noted post stent implantation.Post-dilatation was performed with timi flow 3 and 0% residual stenosis observed following.No additional treatment was provided.On (b)(6) 2021, the patient had presented with recurrent chest pain.Per imaging, 70% isr of the proximal lad, and stenosis of the left circumflex (lcx) was noted.Reportedly, there was no device malfunction.As treatment, angioplasty was performed on the proximal lad and lcx.The event resolved without sequela that same day.No additional information was provided regarding this issue.
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Search Alerts/Recalls
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