BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2911131 · Received January 11, 2013

    Report

    Report Number
    2024168-2013-00236
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 18, 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). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). SERIAL NUMBER CORRECTED FROM (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. DIFFICULT TO DEPLOY/PARTIAL APPOSITION COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BALLOON LEAK/RUPTURE WAS CONFIRMED. BASED ON VISUAL, FUNCTIONAL, AND SCANNING ELECTRON MICROSCOPY (SEM) IMAGING 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. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. SEM LAB RESULTS REVEALED THAT THE RUPTURE MAY BE ATTRIBUTED TO MECHANICAL DAMAGE NOTED ON THE OUTER SURFACE OF THE BALLOON. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING PROCEDURE, A XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION WITHOUT DIFFICULTY. THE BALLOON WAS INFLATED TO 12 ATMOSPHERES FOR FOUR INFLATIONS AND THERE WAS A HOLE FOUND IN THE BALLOON. THE XIENCE PRIME STENT WAS DEPLOYED, BUT NOT FULLY APPOSED TO THE VESSEL WALL. THE XIENCE PRIME SDS WAS REMOVED AND AN UNSPECIFIED NON-COMPLIANT BALLOON WAS USED TO FULLY APPOSE THE STENT TO THE VESSEL WALL SUCCESSFULLY COMPLETING THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT OR NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17419 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2082741

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention