BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1951577 · Received January 6, 2011

    Report

    Report Number
    2024168-2011-00077
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 2, 2010
    Report Date
    December 15, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): FAILURE TO FOLLOW INSTRUCTIONS. THERE WAS NO REPORTED PRODUCT DEFICIENCY. ISCHEMIA AND SHOCK ARE KNOWN ADVERSE EVENTS AS LISTED IN THE PROMUS INSTRUCTIONS FOR USE. 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 OR DESIGN. IT SHOULD BE NOTED THE INSTRUCTIONS FOR USE STATES: EFFECTS OF MULTIPLE STENTING USING PROMUS STENTS COMBINED WITH OTHER DRUG-ELUTING STENTS ARE UNKNOWN. WHEN MULTIPLE DRUG-ELUTING STENTS ARE REQUIRED, USE ONLY PROMUS STENTS IN ORDER TO AVOID POTENTIAL INTERACTIONS WITH OTHER DRUG-ELUTING OR COATED STENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2010, AND THAT AFTER A NON-ABBOTT DRUG ELUTING STENT AND A 3.5 X 12 MM PROMUS STENT WERE DEPLOYED IN AN OVERLAPPING FASHION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD), BEYOND THE STENTS, THE SUBJECT CONTINUED TO HAVE SLOW FLOW. A CATHETER WAS ADVANCED DOWN THE LAD TO GIVE INTRACORONARY ADENOSINE, AS WELL AS SEVEREL FLUSHES OF FRESH BLOOD. THE SUBJECT CONTINUED TO HAVE SLOW FLOW AND ST ELEVATION, WHICH WAS TREATED WITH HEPARIN AND AGGRASTAT AND AN INTRAAORTIC BALLOON PUMP WAS PLACED. ADDITIONALLY, POST PROCEDURE THE SUBJECT WAS EXPERIENCING EPIGASTRIC PAIN AND AN ECHO CARDIOGRAM REVEALED ST ELEVATION. CORONARY ANGIOGRAPHY WAS PERFORMED WHICH REVEALED THE LAD STENTS WERE WIDELY PATENT. THERE WAS AN 85% DISTAL STENOSIS AND A SUBTOTAL OCCLUSION NEAR DISTAL APEX THAT WAS NOTED TO BE TOO SMALL FOR PERCUTANEOUS REVASCULARIZATION. ON (B)(6) 2010, TREATMENT TO A NEW STENOSIS IN THE MID LAD WAS PERFORMED WITH THE PLACEMENT OF A NON-ABBOTT STENT. 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-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention STENT: 3.0 X 24 MM TAXUS LIBERTE