Catalog Number UNK XIENCE |
Device Problem
Difficult or Delayed Activation (2577)
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Patient Problems
Myocardial Infarction (1969); Thrombosis (2100)
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Event Date 07/18/2019 |
Event Type
Injury
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Manufacturer Narrative
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Date of event and implant: estimated date.The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The absorb referenced is being filed under a separate medwatch report number.This copy of copyrighted material was made and delivered to the government under a license from the rights holder or its authorized agent.No further reproduction is permitted.
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Event Description
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It was reported through a research article identifying absorb and xience that may be related to the following; myocardial infarction, device thrombosis, re-hospitalization and final minimal lumen diameter of the scaffold and stent.Additionally, a general statement was made regarding dissatisfaction with absorb.Specific patient information is documented as unknown.Details are listed in the attached article, titled "outcomes of optimised implantation technique with bioresorbable scaffolds: a pooled analysis of absorb-iv and compare-absorb trials".
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Manufacturer Narrative
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D4.Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.The device was not returned for evaluation.A review of the lot history record and complaint history could not be conducted because the part and lot numbers were not provided.The investigation determined a conclusive cause for the reported difficult or delayed activation cannot be determined.The reported patient effects of thrombosis and myocardial infarction are listed in the xience v everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported thrombosis and myocardial infarction, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Manufacturer Narrative
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This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.Attachment: [cn-026598 article.Pdf].
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Search Alerts/Recalls
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