Catalog Number 1125350-33 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Thrombosis (2100); Prolapse (2475)
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Event Date 11/25/2016 |
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 the index procedure on (b)(6) 2016 was to treat a lesion located in the mildly tortuous, mildly calcified, 90% stenosed right coronary artery.Aspiration was performed and white thrombosis was observed.The 3.5 x 33 mm xience alpine stent was deployed and post-dilated.Intra-vascular ultrasound revealed prolapse inside the stent for which a long inflation was performed using a 4.0 x 20 mm non-abbott balloon.The patient was placed on dual-antiplatelet (dapt) medication.Approximately 9 days after the implantation of the 3.50 x 33 mm xience alpine stent and while still hospitalized the patient was observed on angiography to have in-stent thrombosis.An intra-aortic balloon pump was inserted and thrombus aspiration was performed.A 4.00 x 12 mm nc non-abbott balloon catheter was used to dilate the lesion; however, prolapse was observed.A long inflation was performed with a 4.00 x 20 mm non-abbott balloon catheter.The patient remains hospitalized in stable condition.It was confirmed that the patient had been compliant with dapt.No additional information was provided.
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Manufacturer Narrative
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(b)(4).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.The reported patient effect of thrombosis is listed in the xience alpine everolimus eluting coronary stent system instructions for use as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however the reported treatments appear to be related to circumstances of the procedure.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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