BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 4061450 · Received September 4, 2014

    Report

    Report Number
    2134265-2014-05339
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    August 3, 2014
    Report Date
    August 11, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS COMBINATION PRODUCT DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A VISUAL EXAMINATION OF THE CRIMPED STENT FOUND A STENT STRUT 11 ROWS FROM THE DISTAL EDGE OF THE CRIMPED STENT WAS LIFTED UPWARDS FROM THE STENT PROFILE. THE BUMPER TIP OF THE DEVICE SHOWED NO SIGNS OF DAMAGE. THE BALLOON CONES PROFILES WERE REVIEWED AND NO ISSUES WERE NOTED WITH THE OVERALL BALLOON PROFILE. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND TACTILE EXAMINATION FOUND MULTIPLE KINKS ALONG THE HYPOTUBE SHAFT. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. A VISUAL AND TACTILE EXAMINATION FOUND NO ISSUES WITH THE PROFILE OF THE SHAFT POLYMER EXTRUSION. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL. THE 70% STENOSED, DE-NOVO, CONCENTRIC SHAPED, 35MM IN LENGTH TARGET LESION WAS LOCATED IN THE NON-TORTUOUS, MILDLY CALCIFIED, 2.5MM IN DIAMETER LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS PRE-DILATED. A 2.50X38MM PROMUS ELEMENT¿ PLUS DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT; HOWEVER, DURING THE PROCEDURE THE STENT STRUTS BECAME DAMAGED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A 2.5X38MM LIBERTE STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT IS LISTED IN STABLE CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL. THE 70% STENOSED, DE-NOVO, CONCENTRIC SHAPED, 35MM IN LENGTH TARGET LESION WAS LOCATED IN THE NON-TORTUOUS, MILDLY CALCIFIED, 2.5MM IN DIAMETER LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS PRE-DILATED. A 2.50X38MM PROMUS ELEMENT¿ PLUS DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT; HOWEVER DURING THE PROCEDURE THE STENT STRUTS BECAME DAMAGED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A 2.5X38MM LIBERTE STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT IS LISTED IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541520 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918438250 16786177

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR PT2 LS GUIDE WIRE