BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2123463 · Received June 14, 2011

    Report

    Report Number
    2024168-2011-04172
    Event Type
    Death
    Date Received
    June 14, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 20, 2011
    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): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE (B)(4) DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US. THE XIENCE V STENTS ARE BEING FILED UNDER SEPARATE MEDWATCH REPORTS. GUIDE WIRE: RUNTHROUGH. GUIDE CATH: 6F ASAHI INTECC SHEATHLESS AL1.5. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF THROMBOSIS, HYPOTENSION AND DEATH, AS LISTED IN THE PROMUS INSTRUCTIONS FOR USE AND ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, A 2.5X8 XIENCE V STENT AND A NON-ABBOTT STENT WERE IMPLANTED IN THE RIGHT CORONARY ARTERY (RCA). POST PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED AS GOOD. AT A DIFFERENT HOSPITAL ON (B)(6) 2011, A 3.0X15 XIENCE V STENT WAS IMPLANTED IN THE DISTAL RCA PROXIMAL TO THE NON-ABBOTT STENT SLIGHTLY OVERLAPPING, FOR TREATMENT OF A DE NOVO LESION. DURING THE SAME PROCEDURE, A 3.0X12 XIENCE V STENT WAS DEPLOYED IN THE PROXIMAL RCA. POST DILATATION WAS PERFORMED WITH GOOD STENT EXPANSION AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2011, INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED, PRE-DILATATION WAS PERFORMED TWICE AND A 3.0X18 RX PROMUS STENT WAS IMPLANTED IN THE RCA FOR TREATMENT OF A DE NOVO LESION. THE PROMUS STENT WAS NOT OVERLAPPING THE PREVIOUSLY IMPLANTED STENTS. POST IVUS WAS ATTEMPTED; HOWEVER, THE CATHETER COULD NOT ADVANCE. POST-DILATATION WAS NOT PERFORMED. UPON THE COMPLETION OF THE PROCEDURE, NITROGLYCERIN WAS ADMINISTERED. THE PATIENT DEVELOPED A HEADACHE AND MEDICATION WAS ADMINISTERED. THE PATIENT'S BLOOD PRESSURE DECREASED. THE PATIENT ULTIMATELY DIED THE FOLLOWING DAY. CAUSE OF DEATH IS UNKNOWN PENDING AUTOPSY. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 1011241

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death