BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3050852 · Received April 10, 2013

    Report

    Report Number
    2024168-2013-02174
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    December 2, 2012
    Report Date
    March 18, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF DEATH IS A KNOWN OBSERVED AND POTENTIAL ADVERSE EVENT AS LISTED IN THE PROMUS 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). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF ISCHEMIA, MYOCARDIAL INFARCTION, AND THROMBOSIS ARE KNOWN OBSERVED AND POTENTIAL ADVERSE EVENTS AS LISTED IN THE PROMUS 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THE DEVICE REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION RECEIVED STATES ON (B)(6) 2013 WHILE UNDER HOSPICE CARE AT HOME THE SUBJECT EXPIRED. PER THE CERTIFICATE OF DEATH THE CAUSE WAS NOTED AS END STAGE HEART DISEASE, CORONARY ARTERY DISEASE-MITRAL REGURGITATION (MR), PERIPHERAL ARTERIAL DISEASE ADN DIABETES. AN AUTOPSY WAS NOT PERFORMED. ADDITIONALLY, THE PHYSICIAN DID NOT CONSIDER THE DEATH RELATED TO THE PROMUS STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE INDEX PROCEDURE, (B)(6) 2011, OF THE PROXIMAL CIRCUMFLEX ARTERY THE SUBJECT RECEIVED A PROMUS RX STENT. ON (B)(6) 2012, IT WAS REPORTED THAT THE SUBJECT EXPERIENCED RECURRENT ISCHEMIC SYMPTOMS LASTING 10 MINUTES OR MORE. CARDIAC ENZYMES, A REPEAT ANGIOGRAPHY, AND AN ECHOCARDIOGRAM WERE PERFORMED. ON (B)(6) 2012, AFTER ANGIOGRAPHY WITH PERIPROCEDURAL MYOCARDIAL INFARCTION THE SUBJECT UNDERWENT REVASCULARIZATION OF THE PROXIMAL LEFT CIRCUMFLEX ARTERY. ON (B)(6) 2013, THE SUBJECT AGAIN EXPERIENCED RECURRENT ISCHEMIC SYMPTOMS LASTING 10 MINUTES OR MORE AND STENT THROMBOSIS WAS SUSPECTED. CARDIAC ENZYMES, REPEAT ANGIOGRAPHY, AND AN ECHOCARDIOGRAM WERE PERFORMED. ON (B)(6) 2013, AFTER ANGIOGRAPHY SHOWING THROMBOSIS THE SUBJECT UNDERWENT REVASCULARIZATION OF THE LEFT CIRCUMFLEX ARTERY; PERIPROCEDURAL MYOCARDIAL INFARCTION WAS NOTED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148250 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death| H| R| S