A patient experienced migration was reported to abbott.The physician reported the patient's anchor had migrated after initial implant.As a result, the cinch anchor was explanted and replaced to address the issue.The product will not be returned as it was discarded and the date of explant is unknown.The results of the investigation are inconclusive since the devices were not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.During processing of this complaint, attempts were made to obtain complete device and event information.
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Per the physician, the ifu was followed when fixating the anchor during the initial implant.After the initial implant, the cinch anchor was confirmed to have migrated which required the patient to undergo a revision where the anchor was replaced to resolve this issue.The physician believes the cinch anchor is the source of the problem.The product will not be returned as it was discarded and the date of explant is unknown.
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