BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2853020 · Received November 30, 2012

    Report

    Report Number
    2024168-2012-07576
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JO
    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. (B)(4). THE 2.5X8 XIENCE V RX MENTIONED IS BEING REPORTED UNDER A SEPARATE MANUFACTURING REPORT NUMBER. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT COULD 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. IT SHOULD BE NOTED THAT THE XIENCE V/NANO INSTRUCTIONS FOR USE STATES AN UNEXPANDED STENT MAY BE RETRACTED INTO THE GUIDING CATHETER ONE TIME ONLY. AN UNEXPANDED STENT SHOULD NOT BE REINTRODUCED INTO THE ARTERY ONCE IT HAS BEEN PULLED BACK INTO THE GUIDING CATHETER. SUBSEQUENT MOVEMENT IN AND OUT THROUGH THE DISTAL END OF THE GUIDING CATHETER SHOULD NOT BE PERFORMED AS THE STENT MAY BE DAMAGED WHEN RETRACTING THE UNDEPLOYED STENT BACK INTO THE GUIDING CATHETER. SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING WITHDRAWAL OF THE CORONARY STENT SYSTEM, THE ENTIRE SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    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.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL FILED REPORT, ADDITIONAL INFORMATION RECEIVED INDICATED THAT AN UNSPECIFIED 3.5MM 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.

    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 2011141

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention STENT: XIENCE V (2.5X8 MM)