BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿ LONG

    MDR report key: 2200951 · Received August 11, 2011

    Report

    Report Number
    2134265-2011-03296
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 14, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). 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).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE STENT FRACTURE OCCURRED DURING POST DILATION AND WAS TREATED WITH LOW PROLONGED PRESSURE DILATION OF THE BALLOON. THE PATIENT HAD NO SYMPTOMS UNTIL NOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE STENT FRACTURE OCCURRED. THE 80% STENOSED LESION WAS LOCATED IN A NON CALCIFIED AND NON TORTUOUS PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY. A NON BSC GUIDEWIRE CROSSED THE LESION AND WAS PREDILATED WITH A NON BSC BALLOON OF A NON BSC STENT AT SIX TO EIGHT ATMOSPHERES. THE PHYSICIAN THEN PLACED A 2.75X38MM PROMUS ELEMENT AT FOURTEEN ATMOSPHERES. POST DILATATION STARTED FROM THE DISTAL END OF THE STENT WITH A 3.0X8MM NON BSC BALLOON AND A NC 3.0X16MM BALLOON OF A LIBERTE STENT AND THE PROXIMAL PORTION OF THE STENT FOR WELL APPOSITION. THE PHYSICIAN HAD THEN SUSPECTED A STRUT FRACTURE AT THE PROXIMAL PORTION OF THE PROMUS ELEMENT STENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY (B)(4) APPROVED BUT IT IS SIMILAR TO A MARKETED US DEVICE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT HAD NO SYMPTOMS AT ALL , NOT UNTIL NOW AS PREVIOUSLY REPORTED AND CONTINUES REGULAR FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ LONG STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911338270 13975623

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR 3.0X8MM - PATERA LEO - NC BALLON| 2.5X25MM BALLOON OF AN OPTIMUS STENT| PLUS- 0.014"