BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2072960 · Received April 29, 2011

    Report

    Report Number
    2024168-2011-03011
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 7, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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. .ADVANCEMENT AGAINST RESISTANCE. THE PRODUCT WAS NOT RETURNED WHICH MAY HAVE ASSISTED IN THE INVESTIGATION. PHYSICAL RESISTANCE DURING ATTEMPTS TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, PRODUCT PLACEMENT TECHNIQUE, PRODUCT SIZE SELECTION AND ACCESSORY PRODUCT SUPPORT. IT SHOULD BE NOTED THAT THE XIENCE V INSTRUCTION FOR USE (IFU) STATES: SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING CORONARY STENT SYSTEM WITHDRAWAL, THE STENT DELIVERY SYSTEM AND GUIDING CATHETER SHOULD BE REMOVED AS A SINGLE UNIT. IN THIS CASE, ADVANCING THE STENT DELIVERY SYSTEM (SDS) AGAINST RESISTANCE MAY HAVE CONTRIBUTED TO THE REPORTED SHAFT SEPARATION. IT IS POSSIBLE THAT BECAUSE THERE WAS RESISTANCE DURING ADVANCEMENT, THIS COULD HAVE RESULTED IN KINKING OF THE PROXIMAL SHAFT WHICH SUBSEQUENTLY LED TO THE SHAFT SEPARATION, THUS FLUID EXITED FROM THE SHAFT SEPARATION. ADDITIONALLY, IT IS POSSIBLE THAT THE BALLOON NEVER RUPTURED AND THE LOSS OF PRESSURE RESULTED FROM THE SHAFT SEPARATION. IN THIS CASE, WITHOUT THE RETURN OF THE SDS, THE BALLOON RUPTURE CAN NOT BE CONFIRMED AND A CONCLUSIVE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. HOWEVER, THE REPORTED PHYSICAL RESISTANCE AND SHAFT SEPARATION APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND NO OTHER INCIDENTS HAVE BEEN REPORTED FOR SHAFT SEPARATION, BALLOON RUPTURE OR PHYSICAL RESISTANCE FOR HIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE SEVERELY CALCIFIED, 1ST OBTUSE MARGINAL OSTIAL LESION, RESISTANCE WAS MET ADVANCING THE XIENCE V STENT DELIVERY SYSTEM (SDS) OVER THE 90 DEGREE BEND FROM THE LEFT MAIN INTO THE CIRCUMFLEX ARTERY. THE SDS WAS DELIVERED TO THE LESION AND THE STENT WAS IMPLANTED, HOWEVER, DURING INFLATION THE BALLOON RUPTURED AT 12-14 ATMOSPHERES. AT THE SAME TIME, FLUID SPRAY OCCURRED FROM THE PORTION OF THE SHAFT THAT WAS OUTSIDE OF THE BODY AND IT WAS SEEN THAT THE SHAFT HAD BROKEN INTO TWO PIECES. THE DISTAL SHAFT AND ENTIRE BALLOON WERE MANUALLY REMOVED WITHOUT DIFFICULTY AND THERE WAS NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0112641

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention