BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2536279 · Received April 16, 2012

    Report

    Report Number
    2134265-2012-02045
    Event Type
    Injury
    Date Received
    April 16, 2012
    Date of Event
    March 19, 2012
    Report Date
    March 19, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4). 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

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE 80% STENOSED LESION WAS LOCATED IN THE NON-CALCIFIED AND MODERATELY TORTUOUS 1ST DIAGONAL (DX) AND A BRANCH OF THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERIES (LAD). THE LESION IN THE 1ST DX WAS DILATED WITH A 2.25 X 8MM APEX BALLOON CATHETER THAT WAS INFLATED TO 12 ATMS. A 2.5 X 20MM PROMUS ELEMENT STENT WAS DEPLOYED IN THE DISTAL 1ST DX. A 3.0 X 12MM PROMUS ELEMENT WAS DEPLOYED IN THE PROXIMAL 1ST DX. NON-BSC GUIDE WIRES WERE INSERTED INTO 1ST DX AND LAD. KISSING BALLOON TECHNIQUE (KBT) WAS PERFORMED USING A 2.75 X 12MM APEX BALLOON CATHETER ADVANCED TO THE LAD AND A 2.5 X 12MM APEX BALLOON CATHETER ADVANCED TO THE 1ST DX AND INFLATED TO12ATMS. A 2.5 X 20MM PROMUS ELEMENT STENT WAS DEPLOYED IN THE LAD OVERLAPPING THE 3.0 X 12MM PROMUS ELEMENT. KBT WAS PERFORMED AT 12 ATMS WITH A 2.75 X 12MM APEX IN THE LAD AND A 2.5 X 12MM APEX IN THE 1ST DX. CONFIRMATION OF THE LAD WAS OBTAINED WITH AN ATLANTIS IVUS CATHETER. IT WAS NOTICED THAT THE LENGTH OF THE PROMUS ELEMENT 2.5 X 20MM WAS 14MM AND ANGIOGRAPHY REVEALED THAT THE STENT APPEARED DEFORMED. THE NON-BSC GUIDE WIRE IN THE LAD WAS EXCHANGED WITH ANOTHER NON-BSC GUIDE WIRE. A 3.5X8MM NON-BSC STENT WAS DEPLOYED AT 8ATMS AND 16 ATMS. KBT WAS PERFORMED AGAIN USING A 2.75X10MM NON-BSC BALLOON CATHETER ADVANCED TO THE LAD AND A 2.5 X 12MM APEX BALLOON CATHETER ADVANCED TO THE 1ST DX AT 8 AND 9 ATMS. CONFIRMATION OF THE LAD AND THE 1ST DX WAS OBTAINED WITH AN ATLANTIS IVUS CATHETER. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320250 14967418

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention PROMUS ELEMENT 3.0 X 12MM: STENT DELIVERY SYSTEM| APEX 2.5X12: BALLOON CATHETER| APEX 2.75X12: BALLOON CATHETER