BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2840823 · Received November 20, 2012

    Report

    Report Number
    2134265-2012-07111
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    August 15, 2012
    Report Date
    October 25, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(6). DEVICE EVALUATED BY MANUFACTURER : IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    UPDATE: UPN, DESCRIBE EVENT OR PROBLEM, DEVICE LOT NUMBER, DEVICE EXPIRATION DATE, DEVICE MANUFACTURED DATE. CORRECTION: UPN, DEVICE LOT NUMBER, DESCRIBE EVENT OR PROBLEM, EVENT DATE. CORRECTED - UPN CORRECTED FROM (B)(4) TO (B)(4). CORRECTED - DEVICE LOT NUMBER CORRECTED FROM 14831884 TO 15378986. CORRECTED - EVENT DATE CORRECTED FROM (B)(6) 2012 TO UNKNOWN DATE OF (B)(6) 2012, WITH REGARDS TO THE PROGRESSIVE ANGINA. (B)(4).

    Description of Event or Problem · 1

    (B)(4) STUDY. SAME CASE AS: 2134265-2012-07110, 2134265-2012-07112. SAME PATIENT AS: 2134265-2012-06516, 2134265-2012-06517. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED ANGINA AND RESTENOSIS. A 2.25X16MM PROMUS ELEMENT STENT AND A 2.5X8MM ION STENT WAS IMPLANTED IN THE RAMUS ARTERY. A 2.5X8MM PROMUS ELEMENT STENT WAS IMPLANTED IN THE LEFT CIRCUMFLEX ARTERY. IN (B)(6) 2012, THE PATIENT EXPERIENCED PROGRESSIVE ANGINA AND WAS HOSPITALIZED IN (B)(6) 2012. RESTENOSIS OF THE PREVIOUSLY PLACED STUDY STENTS LOCATED IN THE RAMUS WAS TREATED WITH THE PLACEMENT OF A 2.5X16MM AND 2.25X12MM PROMUS ELEMENT STENTS. RESTENOSIS OF THE PREVIOUSLY PLACED 2.5X8MM ION AND 2.25X16MM PROMUS ELEMENT STENTS LOCATED IN THE RAMUS WAS NOTED. ADDITIONALLY, THE RESTENOSIS OF THE PREVIOUSLY PLACED COMMERCIAL STENT (2.5X8MM PROMUS ELEMENT) LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX (CX) WAS TREATED WITH THE PLACEMENT OF A 2.5X20MM PROMUS ELEMENT STENT. ADDITIONALLY, NON- TARGET VESSEL WAS INTERVENED. MEDICATION WAS GIVEN TO TREAT THE EVENT. THE PATIENT WAS DISCHARGED.

    Description of Event or Problem · 1

    (B)(4) STUDY. SAME CASE AS: 2134265-2012-07110, 2134265-2012-07112. SAME PATIENT AS: 2134265-2012-06516, 2134265-2012-06517. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED ANGINA AND RESTENOSIS. A 2.25X16MM PROMUS ELEMENT STENT AND A 2.5X8MM ION STENT WAS IMPLANTED IN THE RAMUS ARTERY. A 2.5X8MM PROMUS ELEMENT STENT WAS IMPLANTED IN THE LEFT CIRCUMFLEX ARTERY. IN (B)(6) 2012, THE PATIENT EXPERIENCED PROGRESSIVE ANGINA AND WAS HOSPITALIZED IN (B)(6) 2012. RESTENOSIS OF THE PREVIOUSLY PLACED STUDY STENTS LOCATED IN THE RAMUS WAS TREATED WITH THE PLACEMENT OF A 2.5X16MM AND 2.25X12MM PROMUS ELEMENT STENTS. RESTENOSIS OF THE PREVIOUSLY PLACED 2.5X8MM ION AND 2.25X16MM PROMUS ELEMENT STENTS LOCATED IN THE RAMUS WAS NOTED. ADDITIONALLY, THE RESTENOSIS OF THE PREVIOUSLY PLACED COMMERCIAL STENT (2.5X8MM PROMUS ELEMENT) LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX (CX) WAS TREATED WITH THE PLACEMENT OF A 2.5X20MM PROMUS ELEMENT STENT. ADDITIONALLY, NON- TARGET VESSEL WAS INTERVENED. MEDICATION WAS GIVEN TO TREAT THE EVENT. THE PATIENT WAS DISCHARGED.

    Description of Event or Problem · 1

    CORRECTED EVENT DESCRIPTION: SAME PATIENT AS MFR #S: 2134265-2012-06516, 2134265-2012-06517, 2134265-2012-07110, 2134265-2012-07112, 2134265-2013-00190, 2134265-2013-00191, 2134265-2013-00192. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED ANGINA AND RESTENOSIS. THE DE NOVO TARGET LESION BEING TREATED WAS LOCATED IN THE RAMUS. THE LESION WAS 80% STENOSED, 2.5MM IN DIAMETER AND 25MM LONG. THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT USING A 2.25X16MM AND 2.5X16MM ION STENTS IN AN OVERLAPPING FASHION. POST DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2012, THE PATIENT EXPERIENCED CHEST PAIN. IN-STENT RESTENOSIS WAS DISCOVERED IN THE RAMUS. THE PATIENT WAS TREATED WITH CUTTING BALLOON ANGIOPLASTY AND PLACEMENT OF A 2.50X8MM ION STENT, A 2.25X16 PROMUS ELEMENT STENT AND A 2.5X8MM PROMUS ELEMENT STENT. IN (B)(6) 2012, THE PATIENT EXPERIENCED PROGRESSIVE ANGINA. THE PATIENT WAS LATER HOSPITALIZED IN (B)(6) 2012. THE PATIENT HAD IN-STENT RESTENOSIS OF THE RAMUS AND LEFT CIRCUMFLEX (LCX) ARTERY. THE PATIENT WAS TREATED WITH A 2.50X20MM PROMUS ELEMENT STENT IN THE LCX AND TWO ION STENTS (2.25X16MM AND 2.50X16MM) IN THE RAMUS. MEDICATION WAS ALSO GIVEN TO TREAT THE EVENT. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. IN (B)(6) 2012, THE PATIENT AGAIN PRESENTED WITH "CONTINUED ANGINA." ANGIOGRAPHY REVEALED 85% DIFFUSE RESTENOSIS OF THE RAMUS. THE PATIENT WAS TREATED WITH AN UNKNOWN TYPE DRUG ELUTING STENT. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493911408250 0014720867

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention