Specific patient information is not available.Complaint was received by xeridiem 10/6/2015 but mdr reportability awareness date is considered to be 12/2/2015 because the latter date is when the complaint trend for valve leakage on 70-0050-xxx triggered further investigation of the issue.Also, the initial complaint report listed a product other than endovive 3s; subsequent information provided by boston on 1/7/2016 indicated that the product was endovive 3s, the product subject to recall as indicated.Xeridiem (legal manufacturer) part number is 70-0050-214; boston (exclusive (b)(4)) part number is m00548350; the boston scientific part number is the one appearing on the device label.Xeridiem is legal manufacturer for the device and (b)(4) is our exclusive distributor.Therefore, the initial reporter to xeridiem is a person associated with (b)(4).The device was not able to be returned for evaluation so a definite cause for the device on this report could not be determined.However, a capa investigation is in process for a trend in valve leakage.This investigation is in process but appears to be pointing towards a design issue with the reflux valve (dome valve).A recall on the 70-0050-xxx devices was initiated on 12/23/2015.Device was not available for evaluation.
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