BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2882647 · Received December 20, 2012

    Report

    Report Number
    2134265-2012-08048
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 20, 2012
    Report Date
    December 3, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#: 2134265-2012-08052. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT HAD SUB-ACUTE STENT THROMBOSIS. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 90% STENOSIS. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF A 3.00 × 28 MM PROMUS ELEMENT STENT. INTRAVASCULAR ULTRASOUND WAS PERFORMED AND THE PROCEDURE WAS COMPLETED. THREE DAYS LATER, ANOTHER TARGET LESION WAS TREATED. THIS LESION WAS LOCATED IN THE 90% STENOSED, MODERATELY TORTUOUS DISTAL LEFT CIRCUMFLEX ARTERY (DIST LCX) WITH PROXIMAL VESSEL DIAMETER OF 3.0 MM AND DISTAL VESSEL DIAMETER OF 2.5 MM. THE PHYSICIAN TREATED THE LESION WITH PLACEMENT OF A 2.50 × 24 MM PROMUS ELEMENT STENT. POST-DILATION WAS PERFORMED USING A 3.0 MM BALLOON CATHETER. EIGHT DAYS POST INITIAL PROCEDURE, THE PATIENT HAD CHEST PAIN. CORONARY ANGIOGRAPHY REVEALED SUB-ACCUTE STENT THROMBOSIS IN THE PROXIMAL TO MID LAD AND DIST LCX. THE PROXIMAL TO MID LAD WAS TREATED WITH PRE-DILATION USING A 2.0 × 15 MM NON-BSC BALLOON CATHETER AND PLACEMENT OF A 3.0 × 22 MM NON-BSC STENT. POST-DILATION WAS PERFORMED USING A 3.0 × 15 MM NON-BSC BALLOON CATHETER. THE DIST LCX WAS TREATED WITH PRE-DILATION USING A 2.0 × 15 MM NON-BSC BALLOON CATHETER AND PLACEMENT OF TWO NON-BSC STENTS OF SIZE 3.0 × 8 MM AND 3.5 × 12 MM. POST-DILATION WAS PERFORMED USING A 3.5 × 15 MM NON-BSC BALLOON CATHETER. THE CURRENT PATIENT CONDITION IS GOOD.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT DURING THE INDEX PROCEDURE, PRE-DILATION WAS PERFORMED PRIOR TO THE STENT PLACEMENT IN THE DIST LCX AND INTRAVASCULAR ULTRASOUND WAS PERFORMED POST STENT PLACEMENT. RESIDUAL STENOSIS FOR BOTH LESIONS IS 0%. TIMI FLOW WAS 3 PRE- AND POST THE PROCEDURE. THE PATIENT WAS DISCHARGED WITH NO COMPLICATIONS REPORTED. THE STENT THROMBOSIS EVENT WAS RESOLVED AND THE PATIENT WAS RECOVERED. THE CAUSE OF THE STENT THROMBOSIS WAS UNKNOWN AS THE PATIENT WAS ADMINISTRATED THE ANTIPLATELET AGENT PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911328300 14990004

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R