BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1923397 · Received December 13, 2010

    Report

    Report Number
    2024168-2010-02705
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    July 15, 2009
    Report Date
    November 18, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE PATIENT. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. OCCLUSION IS A KNOWN ADVERSE EVENT AS LISTED IN THE PROMUS INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 SINGLE USE BIOPSY FORCEPS JUMBO CAPACITY WAS USED DURING A COLONOSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, BIOPSY SAMPLES WERE TAKEN FROM THE TERMINAL ILEUM AND ASCENDING COLON AS PART OF A ROUTINE SCREENING. THE SAME EVENING OF THE PROCEDURE, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO INFECTION (FEVER/SEPSIS) AT THE BIOPSY SITE. THE PATIENT DEVELOPED ILEITIS AND COLITIS AND REMAINED IN THE HOSPITAL FOR FOUR DAYS. IT COULD NOT BE OBTAINED WAS TREATMENTS IF ANY WERE PROVIDED TO THE PATIENT DURING THE HOSPITAL STAY. REPORTEDLY NO ANOMALIES OR DEVICE DAMAGE WAS NOTED DURING THE PROCEDURE AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. THE PATIENT IS IN WELL CURRENT CONDITION AND HAS BEEN DISCHARGED FROM THE HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA CLINICAL TRIAL THAT ON (B)(6) 2009 TWO LESIONS WERE TREATED DURING THE INDEX PROCEDURE, ONE IN THE FIRST DIAGONAL TBAT WAS TREATED WITH A 2.5 X 18 MM PROMUS STENT. ONE IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY THAT WAS TREATED WITH A 3.0X12 MM PROMUS STENT. POST PROCEDURE BASELINE INDEX ANGIO RESULTS FOR THE 1ST DIAGONAL SHOWED NO REFLOW AND ABRUPT CLOSURE POST PROCEDURE. THERE WAS NO REPORTED TREATMENT PERFORMED. THE SUBJECT WAS DISCHARGED ON (B)(6) 2009 ON ASPIRIN AND CLOPIDOGREL. NO ADDITIONAL INFORMATION WAS PROVIDED. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE (B)(4) 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 50 YR Disability