BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2807649 · Received October 29, 2012

    Report

    Report Number
    2024168-2012-06828
    Event Type
    Injury
    Date Received
    October 29, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 4, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE STENTS REMAIN IN THE PATIENT. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE BMW ELITE GUIDE WIRES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORTS.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING, THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT ALSO COULD NOT BE CONDUCTED BECAUSE THE LOT IDENTIFICATION NUMBERS WERE NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF THROMBOSIS, AS LISTED IN THE XIENCE PRIME INSTRUCTIONS FOR USE (IFU), IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION AT THE BIFURCATION OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND THE DIAGONAL BRANCH. THE VESSEL WAS HEAVILY TORTUOUS, WITH HEAVY CALCIFICATION. TWO BALANCE MIDDLEWEIGHT (BMW) ELITE GUIDE WIRES (LOT#2061801) WERE ADVANCED, WITH ONE IN THE LAD AND ONE IN THE DIAGONAL. THE LAD LESION WAS PRE-DILATED AND A XIENCE PRIME STENT WAS DEPLOYED, THEN POST-DILATED WITH A NON-COMPLIANT BALLOON. A THIRD BMW ELITE GUIDE WIRE (LOT#2062001) WAS ADVANCED ACROSS THE STENT; HOWEVER, THE GUIDE WIRE CAUSED A PERFORATION IN THE DIAGONAL VESSEL. THE PERFORATION RESOLVED ITSELF WITHIN A FEW MINUTES. THE BMW GUIDE WIRE IN THE DIAGONAL VESSEL WAS ATTEMPTED TO BE REMOVED, BUT WAS JAILED BY THE STENT. FORCE WAS USED, BUT THE GUIDE WIRE COULD NOT BE REMOVED. A MICRO-CATHETER WAS ADVANCED BEHIND THE STENT TO REMOVE THE WIRE, WHICH WAS SUCCESSFUL; HOWEVER, THE DIAGONAL VESSEL BECAME OCCLUDED AND THE STENT WAS NO LONGER FULLY APPOSED TO THE VESSEL WALL. IT WAS NOTED THAT THROMBUS WAS FORMING IN THE LAD. THE SAME NON-COMPLIANT BALLOON WAS USED AGAIN TO FULLY APPOSE THE STENT TO THE VESSEL WALL. THE FLOW WAS RESTORED IN BOTH THE LAD AND DIAGONAL VESSELS. THE PATIENT WAS GIVEN MEDICATION AND PUT ON A BALLOON PUMP. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDE CATH: FINECROSS