BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1925476 · Received December 14, 2010

    Report

    Report Number
    2024168-2010-02731
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    August 12, 2010
    Report Date
    November 19, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. 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 WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF ANGINA AND RESTENOSIS AND NAUSEA ARE LISTED IN THE PRODUCTS INSTRUCTION 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. THE LCX WAS TREATED FOR THE IN-STENT RESTENOSIS WITH BALLOON ANGIOPLASTY WITH 20% RESIDUAL STENOSIS REQUIRING ADDITIONAL HOSPITALIZATION.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA CLINICAL TRIAL THAT THE TARGET LESION WAS LOCATED IN THE DISTAL LEFT CIRCUMFLEX (LCX), (B)(4), WITH 75% STENOSIS, A LENGTH OF 14 MM, AND REFERENCE VESSEL DIAMETER OF 2.75 MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 X 18 MM STUDY STENT, WHICH RESULTED IN A GRADE A DISSECTION PROXIMAL TO THE TARGET LESION. THE DISSECTION WAS TREATED WITH PLACEMENT OF A 2.75 X 15 MM NON-STUDY PROMUS STENT. FOLLOWING POST-DILATATION RESIDUAL STENOSIS WAS 0%. ON (B)(6) 2010, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO SUBSTERNAL CHEST DISCOMFORT ASSOCIATED WITH DIAPHORESIS AND MILD NAUSEA. OF NOTE: THE PATIENT TOOK CLOPIDOGREL ON A RATHER SPOTTY BASIS. ON (B)(6) 2010, 466 DAYS POST INDEX PROCEDURE, THE SUBJECT UNDERWENT CORONARY ANGIOGRAPHY WHICH REVEALED THE LMCA FREE OF CRITICAL DISEASE, THE LEFT ASCENDING DIAGONAL (LAD): 20% PROXIMAL STENOSIS; 40% OSTIAL STENOSIS OF DIAGONAL. THE LCX (TARGET VESSEL): 20% OSTIAL STENOSIS; 30% OSTIAL STENOSIS IN 1ST OM; INITIAL STENT IN DISTAL LCX WIDELY PATENT, WITH 60-70% OSTIAL PINCHING AT SITE OF OVERLAP; 60-70% IN-STENT RESTENOSIS AT ORIGINAL LESION SITE COVERED BY THE STUDY STENT. THE RIGHT CORONARY ARTERY (RCA): 70% STENOSIS OF SMALL SUB BRANCH. THE LCX WAS TREATED FOR THE INSTENT RESTENOSIS WITH BALLOON ANGIOPLASTY WITH 20% RESIDUAL STENOSIS. THE SUBJECT WAS DISCHARGED ON (B)(6) 2010, ON ASPIRIN AND CLOPIDOGREL. NO ADDITIONAL 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 8093061

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R