BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3222806 · Received July 12, 2013

    Report

    Report Number
    2024168-2013-04333
    Event Type
    Death
    Date Received
    July 12, 2013
    Date of Event
    June 15, 2013
    Report Date
    June 16, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCT: STENT: 2.75X38 RX XIENCE PRIME. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE AN 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. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU) STATES: THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEMS ARE INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO (NEW) NATIVE CORONARY ARTERY LESIONS. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CHEST TIGHTNESS AND BREATHING DIFFICULTY, THUS, VASODILATATION AND PERCUTANEOUS CORONARY INTERVENTION (PCI) WERE INITIATED. DURING THE PCI, AFTER SMOOTH ADVANCEMENT AND DEPLOYMENT OF A 3.0X33 RX XIENCE PRIME STENT IN THE PROXIMAL TO MID AREA OF A MILDLY CALCIFIED 90% RESTENOSED LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY, A 2.75X38 RX XIENCE PRIME STENT WAS SMOOTHLY ADVANCED AND DEPLOYED IN THE MID TO DISTAL AREA OF THE LAD. THE LAD WAS THEN POST-DILATED USING A 3.0X20 UNSPECIFIED BALLOON DILATATION CATHETER. NO RESISTANCE WAS FELT DURING ADVANCEMENT OR RETRACTION OF THE RX XIENCE PRIME STENT DELIVERY SYSTEMS OR THE NON-ABBOTT BALLOON. AT THE CONCLUSION OF THE PROCEDURE, WHILE THE PATIENT EXHIBITED NO SYMPTOMS, THE PATIENT WAS THEN TRANSFERRED TO THE CRITICAL CARE UNIT OF THE HOSPITAL AS ROUTINE. ALTHOUGH THE PHYSICIAN BELIEVES THAT STENT IMPLANTATION IS NOT DIRECTLY RELATED, THE FOLLOWING DAY, WHILE IN CCU, THE PATIENT EXPERIENCED CARDIAC ARREST, AND DESPITE APPLIED CARDIAC MASSAGE AND CARDIOPULMONARY RESUSCITATION (CPR), THE PATIENT EXPIRED DUE TO CARDIAC ARREST. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324258 XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2080741

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death CONCOMITANT MEDICAL DEVICES