Catalog Number 1012463-28 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Prolapse (2475)
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Event Date 06/05/2013 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Date of event has been estimated.Date of implant has been estimated.The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.Literature attachment: lipid plaque modification during resorption of absorb bioresorbable scaffold: insights from optical coherence tomography the additional 3.0x28 absorb is filed under a separate medwatch report number.The absorb device is currently not commercially available in the u.S.; however, it is similar to a device sold in the us.(b)(4).
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Event Description
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It was reported through a presentation titled: lipid plaque modification during resorption of absorb bioresorbable scaffold: insights from optical coherence tomography that the procedure was to treat a large obtuse marginal branch artery.The patient presented with non-st segment elevation myocardial infarction.Two 3.0x28mm absorb bioresorbable vascular scaffolds were implanted at the lesion.Post-procedural optical coherence tomography (oct) revealed complete strut appostion, good scaffold expansion and the absence of fracture.The underlying vessel wall showed signs of plaque prolapsing.Oct was performed 4.6 years later, and demonstrated complete scaffold resorption, with good lumen area, suggesting a considerable modification in the overall lipid content.No additional information was provided.
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Manufacturer Narrative
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(b)(4).Correction: date of event has been estimated, date of implant has been estimated.The device remains in the anatomy.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot numbers were not provided.Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
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Event Description
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Subsequent to filing the initial mdr, the following additional information was received: the index procedure was performed in 2013.No additional information was provided.
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Search Alerts/Recalls
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