Catalog Number UNK ABSORB |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Myocardial Infarction (1969); Thrombosis (2100)
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Event Date 02/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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The date of event has been estimated.The date of implant has been estimated.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.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.Literature attachment.Article title: very late scaffold thrombosis after everolimus-eluting bioresorbable scaffold implantation in patients with unremarkable interim surveillance angiography.The udi number is unknown as the part and lot #s were not provided.
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Event Description
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Patient 8.It was reported that this patient was featured in a journal article titled, "very late scaffold thrombosis [vlsct] after everolimus-eluting bioresorbable scaffold [brs] implantation in patients with unremarkable interim surveillance angiography".Per the article: the patient underwent implantation of two bioresorbable scaffolds (brs) (3.0/18 mm and 3.5/12 mm) in a lesion in the lcx artery (left circumflex).Six-month angiographic follow-up documented a favorable result.1494 days after the index procedure, the patient presented with stemi (st elevation myocardial infarction).Coronary angiography showed vlsct with thrombotic occlusion of the brs.Flow was restored after balloon dilatation and implantation of a des([drug eluting stent).No additional information was provided.
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Search Alerts/Recalls
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