BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2778507 · Received October 9, 2012

    Report

    Report Number
    2024168-2012-06375
    Event Type
    Injury
    Date Received
    October 9, 2012
    Date of Event
    September 14, 2012
    Report Date
    September 14, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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. GUIDE WIRE: BALANCE MIDDLEWEIGHT, WIGGLE, WHISPER ES, GUIDE CATH: VISTA BRITE 6FR 3.5 CORDIS, STENT: 2.25X18 MM XIENCE NANO, 3.0X18 MM XIENCE V. 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 WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED 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 DUE TO THE HEAVY TORTUOSITY AND HEAVY CALCIFICATION IN THE CIRCUMFLEX (CX) ARTERY, USING A RADIAL APPROACH, THREE GUIDE WIRES WERE PLACED FOR SUPPORT. AS THE LEFT ANTERIOR DESCENDING ARTERY (LAD) ALSO REQUIRED TREATMENT, THE FIRST GUIDE WIRE, A BALANCE MIDDLEWEIGHT, WAS PLACED IN THE LAD. PREDILATATION WAS PERFORMED PRIOR TO STENTING THE LAD AND THE CX. THE LAD WAS SUCCESSFULLY TREATED WITH THE DEPLOYMENT OF A 3.0X18 XIENCE V STENT. A WIGGLE GUIDE WIRE AND A WHISPER ES GUIDE WIRE WERE PLACED IN THE CX ARTERY. A 2.25X18 MM XIENCE NANO STENT WAS PLACED SUCCESSFULLY IN THE FAR DISTAL CX WITHOUT ISSUE. AN ATTEMPT WAS THEN MADE TO ADVANCE THE 2.25X15 MM XIENCE NANO STENT DELIVERY SYSTEM (SDS); HOWEVER, RESISTANCE WAS FELT IN THE SECOND CURVE OF THE GUIDING CATHETER DUE TO THE AMOUNT OF DEVICES IN THE GUIDING CATHETER. THE WHISPER ES GUIDE WIRE WAS PULLED BACK TO ALLOW FOR ADVANCEMENT OF THE SDS; HOWEVER, RESISTANCE WAS STILL FELT. THE DECISION WAS MADE TO REMOVE THE DEVICES AS ONE SYSTEM; HOWEVER, DURING RETRACTION, THE STENT IMPLANT CAUGHT ON THE EDGE OF THE GUIDING CATHETER AND DISLODGED ONTO THE WIGGLE GUIDE WIRE. AN ATTEMPT WAS MADE TO CAPTURE THE DISLODGED STENT WITH A 1.5X6 MM MINI TREK BALLOON; HOWEVER, THIS WAS NOT SUCCESSFUL. A 4FR SNARE DEVICE WAS USED TO SNARE THE DISLODGED STENT SUCCESSFULLY FROM THE PATIENT. AFTER ADVANCING A DIAGNOSTIC CATHETER, THE DECISION WAS MADE TO STOP THE PROCEDURE AS THE PHYSICIAN WAS HAPPY WITH THE RESULT ACHIEVED. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. 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 2020341

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention