BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2852992 · Received November 30, 2012

    Report

    Report Number
    2024168-2012-07575
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 6, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED DISSECTION IS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) AS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING AND THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE 2.25X8 XIENCE V RX MENTIONED IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER. THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL FILED MEDWATCH REPORT, ADDITIONAL INFORMATION RECEIVED INDICATED THAT AN UNSPECIFIED 3.5 MM STENT WAS EASILY DEPLOYED IN THE DISTAL LEFT MAIN ARTERY, WITH THE DISTAL EDGE OF THE STENT PARTIALLY COVERING THE DISSECTION. THEN TWO UNSPECIFIED GUIDE WIRES WERE USED TO PUSH THE DISLODGED 2.25X8 XIENCE V RX STENT TO THE DISTAL CIRCUMFLEX ARTERY; THE DISLODGED STENT WAS UNABLE TO BE CRUSHED AGAINST THE VESSEL WALL OR RETRIEVED DUE TO THE SMALL SIZE OF THE VESSEL. THE REMAINING UNSEALED PORTION OF THE REPORTED DISSECTION REMAINED UNTREATED AS THE DISSECTION WAS A STABLE TYPE B DISSECTION. THE PATIENT WAS DISCHARGED IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, AFTER EASY ADVANCEMENT OF TWO UNSPECIFIED GUIDE WIRES PAST A MILDLY CALCIFIED LESION IN THE MID CIRCUMFLEX (CX) CORONARY ARTERY, A 1.2X12 TREK BALLOON DILATATION WAS ADVANCED, WITH DIFFICULTY CROSSING THE LESION, AND THE LESION WAS PRE-DILATED USING THE TREK. A 2.5X8 MM XIENCE V RX STENT WAS THEN ADVANCED AND SUCCESSFULLY DEPLOYED IN THE MID CX; HOWEVER, A DISSECTION WAS NOTED POST DEPLOYMENT. A 2.25X8 XIENCE V RX STENT DELIVERY SYSTEM SDS WAS THEN ADVANCED WITH RESISTANCE TO TREAT A DISSECTION LOCATED IN THE PROXIMAL CX AND GENTLE FORCE WAS APPLIED, HOWEVER, DURING RETRACTION THE STENT DISLODGED. THE DISLODGED STENT WAS PUSHED ALL THE WAY DOWN THE DISTAL CX BRANCH. IT COULD NOT BE RETRIEVED OR CRUSHED. ANOTHER UNSPECIFIED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE DISSECTION WAS LOCATED BETWEEN THE MID CX PROXIMAL STENT EDGE AND DISTAL LEFT MAIN STENT PROXIMAL EDGE. PART OF THE DISSECTION TAGGED NICELY WITH STENT. DISTAL TYPE AND DISSECTION COULD NOT BE SEALED DUE TO IMPOSSIBLE BALLOON ADVANCEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY. 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 2020641

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention