BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3243892 · Received July 23, 2013

    Report

    Report Number
    2024168-2013-04642
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 28, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: GUIDE WIRE: RUNTHROUGH; INFLATION: INDEFLATOR. (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE INFLATION ISSUE WAS CONFIRMED. THE BALLOON RUPTURE WAS NOT CONFIRMED, HOWEVER, THERE WAS A HOLE/LEAK IN THE OUTER MEMBER. BASED ON VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING AN UNSPECIFIED ARTERY ACCESS APPROACH DURING A PROCEDURE OF THE RIGHT CORONARY ARTERY (RCA), THE 2.5 X 18 MM XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS ADVANCED THROUGH THE STENT STRUTS OF A PREVIOUSLY IMPLANTED 2.75 MM XIENCE PRIME STENT WITHOUT REPORTED ISSUE. IT WAS REPORTED THAT THE 2.75 MM XIENCE PRIME WAS IMPLANTED AND BLOOD FLOW WAS IMPROVED; A FLAP-LIKE DISSECTION WAS CONFIRMED DISTAL TO THE STENT. THE DISSECTION REPORTEDLY WAS NOT CAUSED BY THE 2.75 MM XIENCE PRIME. THE 2.5 X 18 MM XIENCE PRIME SDS WAS POSITIONED AT THE DISSECTION AND USING AN INDEFLATOR THE XIENCE PRIME WAS PRESSURIZED/INFLATED BUT THE BALLOON WOULD NOT INFLATE. THE SDS WAS REMOVED FROM THE ANATOMY AND OUTSIDE THE ANATOMY THE BALLOON WAS NOTED TO BE RUPTURED. THE DEVICE WAS NOT USED. A SECOND XIENCE PRIME STENT WAS USED TO TREAT THE DISSECTION. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342155 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2091341

    Patients

    Seq Age Sex Outcome Treatment
    1 CONCOMITANT MEDICAL DEVICES