BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3243459 · Received July 23, 2013

    Report

    Report Number
    2134265-2013-04934
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    May 10, 2013
    Report Date
    June 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A 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 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, STENT DAMAGE POST-DEPLOYMENT AFTER SECONDARY DEVICE INTERACTION OCCURRED. THE PATIENT PRESENTED WITH UNSTABLE ANGINA, HYPERTENSION AND SEVERE NEPHROPATHY. VASCULAR ACCESS SITE WAS OBTAINED VIA THE FEMORAL ARTERY. THE 99% STENOSED, ECCENTRIC, 30 MM DE NOVO TARGET LESION WAS LOCATED IN THE BIFURCATION IN THE MILDLY CALCIFIED AND MILDLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD) AND SECOND DIAGONAL BRANCH. THE LESION WAS NOTED TO HAVE A SIGNIFICANT BEND <=45 DEGREES. TWO 014" NON BSC GUIDEWIRES WERE POSITIONED. THE FIRST IN THE LAD, THE SECOND IN THE SECOND DIAGONAL BRANCH. AFTER THE 2 TARGET LESIONS WERE PRE-DILATATED WITH A 2.00 X 20 MM EMERGE MR CATHETER BALLOON 3 TIMES AT 12 ATMOSPHERES FOR 6 SECONDS, THE PHYSICIAN IMPLANTED THE FIRST 3.00 X 28 MM PROMUS ELEMENT DRUG ELUTING STENT IN THE LAD. THE PHYSICIAN THEN POST-DILATED THE STENT WITH A 3.5 X 15 MM AND 3.75 X 12 MM NC QUANTUM APEX CATHETER BALLOON FOR 4 TIMES AT 20 ATMOSPHERES IN 12 SECONDS. AFTER CHANGING THE WIRES, THE PHYSICIAN PROCEEDED TO DILATE SOME STRUTS OF THE 3.00 X 28 MM PROMUS ELEMENT DRUG ELUTING STENT IN THE LAD WITH A 2.50 X 12 MM EMERGE AT 10 ATMOSPHERES FOR 10 SECONDS AND IMPLANTED THE SECOND 2.50 X 12 MM PROMUS ELEMENT DRUG ELUTING STENT AT THE ORIGIN OF THE SECOND DIAGONAL BRANCH. THE PHYSICIAN CONTINUED WITH A KISSING BALLOON TECHNIQUE WITH A 3.50 X 12 MM EMERGE MR CATHETER BALLOON IN THE LAD AND PROMUS ELEMENT BALLOON IN SECOND DIAGONAL BRANCH, BUT SHE NOTICED A HIGHER RADIOPACITY AT THE PROXIMAL EDGE OF THE FIRST PROMUS ELEMENT IMPLANTED. THERE WAS LONGITUDINAL SHORTENING OF THE PROXIMAL EDGE OF THE 3.0 0X 28 MM PROMUS ELEMENT DRUG ELUTING STENT. THERE WAS A STENT COMPRESSION AT THE PROXIMAL EDGE OF THE STENT , MORE VISIBLE THAN THE OTHER PARTS OF THE STENT. SO THE PHYSICIAN DECIDED TO STENT THE PROXIMAL EDGE WITH A 4.00 X 8 MM NON BSC STENT. AT THE END OF THE PROCEDURE, THE RESULTS WERE GOOD. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344026 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911328300 15937136

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention EMERGE MR 2.00X20MM| NC QUANTUM APEX 3.75X12MM| 2 GUIDE WIRES (BMW 0,014")| NC QUANTUM APEX 3.5X15MM| EMERGE 2.50X12MM