BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2842542 · Received November 21, 2012

    Report

    Report Number
    2024168-2012-07370
    Event Type
    Death
    Date Received
    November 21, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 29, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANT DATE - ESTIMATED. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF DEATH IS A KNOWN OBSERVED AND POTENTIAL ADVERSE EVENT AS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. HOWEVER, THE PATIENT WENT INTO CARDIO-RESPIRATORY ARREST AND WAS CONFIRMED TO HAVE EXPIRED. AS THE PATIENT WAS NOT IN A CATH LAB WHEN HER STATUS CHANGED, NO ANGIOGRAPHY WAS PERFORMED. THE PHYSICIAN COMMENTED THAT THE PATIENT DEATH WAS ASSUMED TO HAVE BEEN CAUSED BY THE NON-ABBOTT STENT DISLODGEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THE STENT REMAINS IN THE PATIENT. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE 3.0 X 23 MM PROMUS REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 3.0 X 23 MM PROMUS STENT AND A 2.5 X 23 MM XIENCE V STENT HAD BEEN IMPLANTED IN THE LEFT MAIN (LM) TO PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) DURING A PRIOR PROCEDURE. AN ATTEMPT WAS MADE TO DELIVER AN UNSPECIFIED IVUS CATHETER TO THE PROXIMAL LEFT CIRCUMFLEX (LCX), BUT IT FAILED TO CROSS. AN UNSPECIFIED NON-COMPLIANT BALLOON CATHETER WAS USED TO DILATE THE AREA IN WHICH THE PREVIOUSLY PLACED STENTS WERE IMPLANTED. THE IVUS WAS AGAIN ATTEMPTED; HOWEVER IT STILL DID NOT CROSS. THUS, DIRECT-STENTING OF A NON-ABBOTT STENT WAS ATTEMPTED. HOWEVER, RESISTANCE WAS MET AROUND THE BIFURCATION AT THE LCX, PROBABLY DUE TO THE NON-ABBOTT STENT COMING INTO CONTACT WITH THE IMPLANTED PROMUS STENT. ALTHOUGH THE STENT WAS ABLE TO CROSS THE LESION, AS STRONG RESISTANCE WAS MET DURING ADVANCEMENT, IT WAS DECIDED TO NOT DEPLOY THE NON-ABBOTT STENT, PER THE DEVICE'S INSTRUCTIONS FOR USE (IFU), TO AVOID CAUSING COMPLICATION. SO THE NON-ABBOTT STENT WAS ATTEMPTED TO BE WITHDRAWN, BUT IT BECAME CAUGHT ON THE IMPLANTED PROMUS STENT AND THE NON-ABBOTT STENT BECAME DISLODGED. THE DISLODGED NON-ABBOTT STENT COULD NOT BE DEPLOYED, AS THE EDGE WAS CAUGHT ON THE PROMUS. WHEN PULLED WITH FORCE, THE NON-ABBOTT STENT BECAME ELONGATED AND ALMOST HALF OF THE STENT PROTRUDED INTO THE LM. AN ATTEMPT WAS MADE TO COLLECT THE NON-ABBOTT STENT WITH A SNARE, BUT WAS UNSUCCESSFUL. THE PATIENT WAS TO BE TRANSFERRED TO ANOTHER HOSPITAL TO UNDERGO A SURGICAL PROCEDURE AND WAS MOVED FROM THE CATH LAB TO ANOTHER ROOM. WHILE AWAITING TRANSFER, AN ANOMALY IN BLOOD PRESSURE WAS OBSERVED AND AN INTRA-AORTIC BALLOON PUMP (IABP) WAS INSERTED.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death STENT: 3.0 X 23 MM PROMUS, PROMUS ELEMENT