BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2149867 · Received July 5, 2011

    Report

    Report Number
    2024168-2011-04768
    Event Type
    Injury
    Date Received
    July 5, 2011
    Date of Event
    May 12, 2011
    Report Date
    June 10, 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. THE 2.75 X 28 MM PROMUS IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE US. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED ANGINA AND RE-STENOSIS ARE LISTED IN THE INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING AND THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, THE PATIENT PRESENTED WITH STABLE ANGINA. ANGIOGRAPHY WAS PERFORMED WHICH NOTED SEVERAL LESION SITES. A LESION IN THE 1ST DIAGONAL AND ANOTHER IN THE LEFT CIRCUMFLEX (LCX) WERE TREATED WITH THE PLACEMENT OF TWO NON-ABBOTT STENTS. THREE PROMUS STENTS WERE ALSO IMPLANTED IN THIS PROCEDURE. A 2.75 X 18 MM PROMUS STENT WAS IMPLANTED IN THE LEFT ANTERIOR DESCENDING (LAD) REACHING INTO THE DIAGONAL. A 2.75 X 28 MM PROMUS STENT WAS IMPLANTED IN THE MID TO PROXIMAL LAD. AN UNSPECIFIED PROMUS WAS IMPLANTED IN THE LEFT MAIN. THE PATIENT WAS DISCHARGED ON (B)(6) 2010 ON ASPIRIN AND PRASUGREL. ON (B)(6) 2011, 144 DAYS POST INDEX PROCEDURE, THE SUBJECT RETURNED WITH ACUTE SUBSTERNAL CHEST PAIN THAT WAS NOT RELIEVED WITH NITROGLYCERIN, SHORTNESS OF BREATH AND NAUSEA. ECG NOTED SINUS BRADYCARDIA WITH T-WAVE INVERSIONS, BUT NO ST CHANGES. THERE WERE Q WAVES INFERIORLY. INITIAL TROPONIN SHOWED NO SIGNS OF CARDIAC DAMAGE. NO MYOCARDIAL INFARCTION WAS REPORTED. CATHETERIZATION WAS PERFORMED THE FOLLOWING DAY, NOTING RESTENOSIS IN THE TWO NON-ABBOTT STENTS IN THE 1ST DIAGONAL AND THE LCX. A WIDELY PATENT LEFT MAIN CORONARY ARTERY WAS OBSERVED, AND A VERY HIGH GRADE 95% TO 99% STENOSIS WAS NOTED IN THE MID-LAD. THIS WAS TREATED VIA BALLOON ANGIOPLASTY AND PLACEMENT OF A 3.5 X 33 MM NON-ABBOTT STENT. A REPEAT ECG ON (B)(6) 2011 SHOWED NO ACUTE CHANGES AND THE PATIENT WAS DISCHARGED THE SAME DAY. 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 0032541

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R STENT: PROMUS (2.75X28)