Catalog Number UNK ABSORB |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Ischemia (1942); Myocardial Infarction (1969); Thrombosis (2100)
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Event Date 06/27/2017 |
Event Type
Injury
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Manufacturer Narrative
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Date of event: date is estimated.The scaffolds remain in the patients.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the u.S.
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Event Description
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It was reported in a research article that absorb bioresorbable vascular scaffold (bvs) may be related to target vessel myocardial infarction, ischemia driven target lesion revascularization, and scaffold thrombosis with a median follow up of 2 years.Additional details can be found in the attached article "first-generation bioresorbable vascular scaffolds disappearing stents or disappearing evidence?".
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Manufacturer Narrative
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The device was not returned for analysis.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot and part number were not provided.A conclusive cause for the difficulties listed can not be determined based on the limited information available.The patient effects listed are consistent with the product risk profile and are therefore expected.
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Search Alerts/Recalls
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