Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Aneurysm (1708)
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Event Date 04/09/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event - estimated.Date of implant - estimated.The scaffold remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The other absorb device referenced is filed under a separate medwatch report.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.
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Event Description
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It was reported that in 2016, the patient underwent a coronary procedure, with implantation of an absorb bioresorbable vascular scaffold (bvs) in the mid right coronary artery (rca) and an absorb bvs in the circumflex (cx) artery.Two years post procedure, the patient presented with symptoms and it was noted that the patient had a significant aneurysm in the mid rca and some aneurysmal appearance in the cx.No additional information was provided.
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Manufacturer Narrative
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(b)(4).The unique device identifier (udi) is unknown because the part and lot numbers were not provided.There was no reported device malfunction and the product was not returned as the scaffold remains in the anatomy.A review of the lot history record could not be conducted because the part and lot numbers were not provided.The reported patient effect of aneurysm as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use is a known adverse event associated with the use of a coronary scaffold in native coronary arteries.A conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined.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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