BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 4243955 · Received November 11, 2014

    Report

    Report Number
    2134265-2014-07006
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 22, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AE OR PRODUCT PROBLEM: CORRECTED FROM PRODUCT PROBLEM TO REPORTED ISSUE IS BOTH AN ADVERSE EVENT AND PRODUCT PROBLEM. TYPE OF REPORTABLE EVENT: CORRECTED FROM MALFUNCTION TO SERIOUS INJURY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS A COMBINATION PRODUCT. (B)(4). IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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 IMPLANTED 4.00X24MM PROMUS ELEMENT¿ PLUS STENT WAS NOTED TO BE SHORTER IN LENGTH. AN UNSPECIFIED BALLOON CATHETER WAS USED FOR POST DILATION OF THE STENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEPLOYMENT ISSUE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE LEFT MAIN CORONARY ARTERY (LMCA) TO LEFT ANTERIOR DESCENDING ARTERY (LAD). A 7FR 3.5 XB UNSPECIFIED GUIDE CATHETER WAS PLACED. AFTER A NON BSC GUIDE WIRE CROSSED THE LAD, ANOTHER NON BSC GUIDE WIRE WAS PLACED IN THE LEFT CIRCUMFLEX ARTERY. INTRAVASCULAR ULTRASOUND WAS PERFORMED IN THE LMCA TO LAD WHICH REVEALED A MINIMAL LUMEN AREA (MLA) OF 3.1 MMSQ WITH A VESSEL SIZE OF 4.2MM. THE TARGET LESION WAS PREDILATED USING A 2.75X12MM NON BSC BALLOON CATHETER. SUDDENLY, THE PATIENT DEVELOPED BRADYCARDIA AND WENT INTO CARDIAC ARREST. CARDIOPULMONARY RESUSCITATION WAS ADMINISTERED IMMEDIATELY AND THE PATIENT RECOVERED. SOON AFTER, A 4.00MM X 24MM PROMUS ELEMENT¿ PLUS STENT WAS DEPLOYED ACROSS THE LMCA AND LAD AT 12 ATMOSPHERES FOR 10 SECONDS. REDILATION WAS DONE USING THE STENT DELIVERY SYSTEM (SDS) BALLOON AT 16 ATMOSPHERES FOR 10 SECONDS. POST DILATION WAS PERFORMED USING A 4X12MM AND A 5X8MM NON BSC BALLOON CATHETERS. IT WAS THEN NOTED THAT THERE WAS A CHANGE IN STENT "CONFORMITY" ACROSS THE LENGTH. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726120 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918424400

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention BALLOON CATHETER: 2.75X12 MM NC TREK| GUIDE WIRE: RINATO, RUNTHROUGH