BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS PREMIER?

    MDR report key: 3926238 · Received July 10, 2014

    Report

    Report Number
    2134265-2014-03915
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 11, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: 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).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2014-04119. (B)(4). IT WAS REPORTED THAT VESSEL DISSECTION OCCURED. IN (B)(6) 2014, THE PATIENT PRESENTED WITH COMPLAINTS OF CHEST PAIN AND WAS DIAGNOSED WITH ANGINA AND NON-ST ELEVATION MYOCARDIAL INFARCTION. THE PATIENT WAS HOSPITALIZED. CARDIAC CATHETERIZATION WAS RECOMMENDED. AT THE TIME OF EVENT, THE PATIENT WAS TAKING ONLY ASPIRIN. THE STUDY DRUG WAS LAST TAKEN ON DECEMBER 2012 AND OTHER ANTIPLATELET MEDICATION WAS NEVER TAKEN. CORONARY ANGIOGRAPHY REVEALED PATENT STUDY STENT IN DISTAL SEGMENT; 80% OSTIAL STENOSIS IN THE FIRST RIGHT POSTERIOR DESCENDING ARTERY (R-PDA), 70% PROXIMAL STENOSIS IN 1ST RIGHT POSTEROLATERAL (RPL). THE PT2 GUIDE WIRE WAS USED IN RPL AND RUN-THROUGH IN R-PDA, AN ATTEMPT WAS MADE TO CROSS 80% OSTIAL STENOSIS IN R-PDA WITH 1.5 EMERGE BALLOON CATHETER. HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION. THE OSTIAL LESION IN R-PDA WAS THEN PRE-DILATED USING A 1.25 MM NON-BSC BALLOON CATHETER FOLLOWING WHICH THE 2.0 MM EMERGE BALLOON WAS ABLE TO CROSS THE LESION AND WAS USED TO DILATE R-PDA. AN ATTEMPT WAS MADE TO CROSS 2.25 X 28 MM PROMUS PREMIER¿ STENT HOWEVER IT WAS UNABLE TO CROSS AND THE LESION WAS FURTHER PRE-DILATED USING 2.25 X 12 MM EMERGE BALLOON CATHETER AT 16 ATMOSPHERES, BUT STILL THE STENT WAS UNABLE TO CROSS. A NON-BSC GUIDE CATHETER WAS USED AND THE GUIDE WIRE WAS PULLED BACK FROM RPL. THE GUIDE CATHETER WAS ADVANCED OVER INFLATED 2.25 X 12 MM EMERGE BALLOON CATHETER, BUT THE STENT WAS STILL UNABLE TO CROSS. AT THIS POINT THERE WAS FLOW LIMITING DISSECTION NOTED WHICH WAS TREATED WITH 2.0MM BALLOON AND PLACEMENT OF 2.25 X 28 MM PROMUS ELEMENT PLUS STENT FROM RCA TO RPL AT 12 ATMOSPHERES. FOLLOWING WHICH, THERE WAS RESIDUAL DISSECTION NOTED AT THE DISTAL EDGE OF THE 2.25 X 28 MM PROMUS PREMIER¿ STENT AND WAS TREATED WITH THE PLACEMENT OF 2.25 X 8 MM PROMUS ELEMENT PLUS STENT AT 12 ATMOSPHERES. POST-DILATION WAS DONE AT 20 ATMOSPHERES. FOLLOWING DILATION, THE PATIENT HAD TIMI FLOW OF 3 IN BOTH BRANCHES AND MINIMAL STENOSIS OF PDA. ONE DAY POST PROCEDURE, THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND WAS DISCHARGED ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404734 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493952828220 16707672

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention