BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2121698 · Received June 13, 2011

    Report

    Report Number
    2024168-2011-04138
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    December 14, 2010
    Report Date
    May 19, 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. (B)(6). 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. THERE WAS NO REPORTED PRODUCT DEFICIENCY. ENZYME ELEVATION, EKG CHANGES, AND MI 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, COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4). DILATATION CATHETER: SCOREFLEX 3.0X15. GUIDEWIRE: SION BLUE. GUIDE CATH: LUMINA 6F UBS 3.5. THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA AND OCCLUSION 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, DESIGN, OR LABELING.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT FILED, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT AFTER DEPLOYMENT OF THE PROMUS STENT IN THE MILDLY TORTUOUS AND CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY, THE PATIENT EXPERIENCED CHEST SYMPTOMS. ALTHOUGH GOOD BLOOD FLOW WAS CONFIRMED, THE ANGIOGRAM REVEALED THAT THE SEPTAL BRANCHES WERE OCCLUDED DUE TO THE PROMUS STENT JAILING THEM. THE PATIENT SYMPTOMS RESOLVED AFTER TWO MEDICATIONS WERE GIVEN, SIGMART AND CARPERITIDE. THE CARDIAC ENZYMES RETURNED TO NORMAL ON (B)(6) 2010. THOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PROMUS WAS IMPLANTED IN AN UNKNOWN TARGET LESION ON (B)(6) 2010. THE PATIENT WAS FOUND TO HAVE ELEVATED CARDIAC ENZYMES AND THE ECG SHOWED AN ST ELEVATION MYOCARDIAL INFARCTION (MI). THE PATIENT WAS TREATED WITH MEDICATION. THE CONDITION RESOLVED WITHOUT SEQUELA ON (B)(6) 2010 AND THE PATIENT WAS DISCHARGED HOME. THERE WAS NO ADDITIONAL INFORMATION 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 9112041

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| S