BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2211954 · Received August 15, 2011

    Report

    Report Number
    2024168-2011-05739
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    May 9, 2011
    Report Date
    July 21, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED ANEURYSM AND ANGINA ARE KNOWN ADVERSE EVENTS LISTED IN THE PROMUS INSTRUCTIONS FOR USE (IFU). 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. 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

    REPORTEDLY THE PATIENT UNDERWENT AN INDEX PROCEDURE ON (B)(6) 2011 TO TREAT A BIFURCATION DURING WHICH A 3.5 X 28 MM PROMUS STENT WAS IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND A 3.5 X 28 MM NON-ABBOTT STENT WAS IMPLANTED IN THE CIRCUMFLEX WITHOUT INCIDENT. HOWEVER, ON (B)(6) 2011, THE PATIENT RETURNED TO THE HOSPITAL COMPLAINING OF CHEST PAIN AND AN ANEURYSM WAS IDENTIFIED SURROUNDING THE TWO STENTS. AT THIS TIME IT WAS DECIDED THAT NO TREATMENT WOULD BE DONE; HOWEVER, ON (B)(6) 2011 THE PATIENT RETURNED FOR A FOLLOW-UP VISIT AND IT WAS FELT THAT THE ANEURYSM HAD GROWN. CORONARY ARTERY BYPASS GRAFT SURGERY WAS DISCUSSED FOR TREATMENT; HOWEVER, THE PHYSICIAN FELT THAT IT WOULD BE TOO DIFFICULT TO GET TO THE PROXIMAL LAD. AT THIS TIME NO FURTHER MEDICAL TREATMENT HAS BEEN PERFORMED; HOWEVER, THE PATIENT IS SCHEDULED FOR ROUTINE FOLLOW-UP. NO ADDITIONAL EVENT OR PATIENT INFORMATION WAS 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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Disability STENT: 3.5 X 28 MM TAXUS