BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1932354 · Received December 17, 2010

    Report

    Report Number
    2024168-2010-02811
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    June 3, 2009
    Report Date
    November 22, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. DISSECTION AND MYOCARDIAL INFARCATION (MI) ARE KNOWN ADVERSE EVENTS AS LISTED IN THE PROMUS INSTRUCTIONS FOR USE. THE IFU FURTHER STATES THAT IMPLANTING A STENT MAY LEAD TO DISSECTION OF THE VESSEL DISTAL AND / OR PROXIMAL TO THE STENT AND MAY CAUSE ACUTE CLOSURE OF THE VESSEL REQUIRING ADDITIONAL INTERVENTION (CABG, FURTHER DILATATION, PLACEMENT OF ADDITIONAL STENTS, OR OTHER). THE DISSECTION WAS TREATED WITH AN ADDITIONAL PROMUS 2.5 X 12 MM STENT (ADDITIONAL THERAPY/NONSURGICAL TREATMENT). 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 OR DESIGN.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE STENT REMAINS IN THE PATIENT. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE 2.5X12 PROMUS (1009539-12B, UNK) IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT ATRIAL (RA) LEAD WAS DETERMINED TO BE FRACTURED DURING THE NORMAL DEVICE CHANGE OUT AND DEVICE SYSTEM UPGRADE. THERE WERE NO REPORTED ADVERSE PATIENT SYMPTOMS ASSOCIATED WITH THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INDEX PROCEDURE OCCURRED (B)(6) 2009. THE TARGET LESION WAS LOCATED IN THE DISTAL LEFT CIRCUMFLEX ARTERY (LCX) WITH 95% STENOSIS AND WAS 14 MM LONG WITH A 2.5 MM REFERENCE VESSEL DIAMETER. PRE-DILATATION WAS PREFORMED AND A PROMUS 2.5 X 18 STENT WAS DEPLOYED. FOLLOWING STENT PLACEMENT, IT WAS NOTED THAT THERE WAS A DISTAL EDGE DISSECTION. THE DISSECTION WAS TREATED WITH AN ADDITIONAL PROMUS 2.5 X 12 STENT. FOLLOWING POST-DILATATION RESIDUAL STENOSIS WAS 0%. A NON-TARGET LESION LOCATED IN THE PROXIMAL LAD WAS TREATED WITH PLACEMENT OF A UNKNOWN BARE METAL STENT DURING THE INDEX PROCEDURE. POST PROCEDURE CARDIAC ENZYMES WERE NOTED TO BE ELEVATED. THE SITE REPORTED AN EVENT OF ELEVATED TROPONIN LEVELS AT DISCHARGE OCCURRING ON (B)(6) 2009. THE TROPONIN ELEVATION WAS CONSISTENT WITH PROTOCOL DEFINITION OF MYOCARDIAL INFARCTION (MI) AND ARC DEFINITIONS. THE WAS NO REPORTED TREATMENT FOR THE MI. THE EVENT RESOLVED WITHOUT RESIDUAL EFFECTS AND THE SUBJECT WAS DISCHARGED ON (B)(6) 2009 AND PRESCRIBED ASPIRIN AND CLOPIDOGREL. RELATIONSHIP TO INDEX PROCEDURE PER INVESTIGATOR: HIGHLY PROBABLE. RELATIONSHIP TO INDEX PROCEDURE PER INVESTIGATOR: POSSIBLE. RELATIONSHIP OF MI TO TARGET VESSEL - RELATED. 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.

    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 73 YR Required Intervention| S