BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3150676 · Received June 6, 2013

    Report

    Report Number
    2024168-2013-03537
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    March 14, 2013
    Report Date
    May 13, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS. SUBSEQUENT INFORMATION REVEALED THAT THE DEVICE IS NOT RETURNING AND IS NOT AVAILABLE FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. HOWEVER, A CINE REVIEW OF THE PROCEDURE CONFIRMED THE REPORTED DEVICE ISSUE. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEPLOYMENT OF A 3.5X18 RX XIENCE PRIME STENT IN AN UNSPECIFIED VESSEL, THE STENT BALLOON INFLATED UNEQUALLY, EXPANDING THE PROXIMAL STENT STRUTS AND THEN THE DISTAL STENT STRUTS. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. ABBOTT CLINICAL ANALYSIS OF THE PROCEDURAL CINE INDICATES THAT AN UNSPECIFIED STENT WAS DEPLOYED IN THE DIAGONAL ARTERY. THE IMAGES SUGGEST THAT THERE MAY HAVE BEEN SOME PLAQUE SHIFT INTO THE LEFT ANTERIOR DESCENDING ARTERY (LAD). DILATATION IS PERFORMED IN THE LAD AT THE BIFURCATION. A STENT IS POSITIONED IN THE LAD AND THE BALLOON IS INFLATED, TAKING APPROXIMATELY 8 SECONDS TO FULLY EXPAND. THE EXPANSION STARTS AT THE PROXIMAL END OF THE BALLOON EXPANDING FULLY ABOUT MID-WAY AT WHICH POINT THE DISTAL END FULLY EXPANDS FOLLOWED BY THE DISTAL ONE-THIRD OF THE BALLOON. POST-DILATATIONS ARE PERFORMED IN THE LAD AND DIAGONAL INCLUDING KISSING INFLATIONS. ABBOTT CLINICAL ANALYSIS CONCLUDES THAT THE UNUSUAL SEQUENCE OF INFLATION OF THE STENT BALLOON IN THE LAD MAY HAVE BEEN DUE TO RESISTANCE IN THE LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250831 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2061541

    Patients

    Seq Age Sex Outcome Treatment
    1