BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1913198 · Received December 2, 2010

    Report

    Report Number
    2024168-2010-02584
    Event Type
    Death
    Date Received
    December 2, 2010
    Date of Event
    July 8, 2010
    Report Date
    November 10, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE PATIENT. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE RX PROMUS (1009539-12B, (B)(4)) IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER. BALLOON CATHETER: VOYAGER; GUIDE WIRE: TERUMO, WHISPER, PILOT, ALLSTAR.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. RENAL FAILURE, INFECTION AND DEATH ARE ALSO LISTED AS KNOWN ADVERSE EVENTS OF CORONARY STENTING IN THE PROMUS INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP, IF ANY, TO THE DEVICE CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE OR DESIGN.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT STATING, "WHEN THEY EXTUBATED THE PATIENT THEY REALIZED THE CUFF HAD BECOME DISCONNECTED AND MIGRATED DOWN THE ET TUBE." KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE KIMBERLY-CLARK COMPLAINT DATABASE AND IDENTIFIED AS RECORD (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6), 2010, IN THE PRESENCE OF STABLE ANGINA AND NOT IN THE PRESENCE OF ACUTE CORONARY SYNDROME, THE PATIENT UNDERWENT THE INDEX PROCEDURE WITH DEPLOYMENT OF TWO PROMUS STENTS IN THE PROXIMAL LEFT ASCENDING ARTERY. POST STENT DEPLOYMENT RESIDUAL STENOSIS WAS 0%. (THE PATIENT DID NOT RECEIVE A PERI PROCEDURAL LOADING DOSE OF CLOPIDOGREL. ON (B)(6) 2010, THE PATIENT BEGAN 75 MG CLOPIDOGREL DOSING. ON AN UNKNOWN DATE, THE PATIENT BEGAN ASPIRIN 325 MG DOSING.) ON (B)(6), 2010, THE PATIENT WAS DISCHARGED FROM THE INDEX PROCEDURE HOSPITALIZATION. ON (B)(6), 2010, THE PATIENT SUFFERED SUDDEN DEATH. THE CAUSE OF DEATH WAS REPORTED AS HYPERCAPNIC RESPIRATORY FAILURE. AN AUTOPSY WAS NOT PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE (B)(4) DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE US.

    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 9072861

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death RX PROMUS (1009539-12B, (B)(4))