BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3012787 · Received March 20, 2013

    Report

    Report Number
    2134265-2013-01574
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: (B)(6). DEVICE IS A 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 - RETURNED PRODUCT CONSISTED OF A PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM (SDS) WITH A SYRINGE ATTACHED TO THE MANIFOLD AND THE PROMUS ELEMENT PLUS STENT ATTACHED TO A GUIDEWIRE AND SNARE. THE BALLOON WAS TIGHTLY FOLDED WITH STENT IMPRESSIONS ON THE SURFACE OF THE BALLOON BETWEEN THE MARKERBANDS. THE STENT WAS INSPECTED AND MAJORITY OF THE STRUTS WERE BENT, FLARED AND STRETCHED. INSPECTION OF THE DEVICE PRESENTED NO DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE REPORTED EVENT. 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).

    Additional Manufacturer Narrative · 1

    UPDATED: AGE AT TIME OF EVENT, DESCRIBE EVENT OR PROBLEM, OTHER RELEVANT HISTORY, THERAPY DATES AND DESC, COMPLAINT SOURCE. CITATION: IVAN HANSON, MD, JUSTIN TRIVAX, MD, GEORGE HANZEL, MD. 2014. SNARE REMOVAL OF A DEFORMED CORONARY STENT VIA RADIAL ARTERY DURING PERCUTANEOUS INTERVENTION FOR ACUTE MYOCARDIAL INFARCTION. THE JOURNAL OF INVASIVE CARDIOLOGY® VOL. 26, NO. 1, JANUARY 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, STENT DAMAGE AND DISLODGEMENT OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED RIGHT CORONARY ARTERY (RCA). THE LESION WAS PRE-DILATED RESULTING IN 80% RESIDUAL STENOSIS. AS THE 4.0X32MM PROMUS ELEMENT PLUS STENT WAS ADVANCED PAST THE GUIDE CATHETER TIP THE DEVICE WOULD ENCOUNTER RESISTANCE AND BE PUSHED BACK INTO THE GUIDE CATHETER LUMEN. DUE TO INTERACTION WITH THE TIP OF THE GUIDE CATHETER THE STENT WAS SHORTENED AND FLARED AND WOULD NO LONGER ENTER TO GUIDE CATHETER LUMEN. THE GUIDE CATHETER AND STENT SYSTEM WERE REMOVED WITH THE WIRE IN PLACE, HOWEVER THE STENT DISLODGED BUT REMAINED ON THE WIRE. THE DISLODGED STENT WAS SNARED AND REMOVED FROM THE PATENT. THE PROCEDURE WAS COMPLETED WITH TWO ADDITIONAL PROMUS ELEMENT STENTS. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, STENT DAMAGE AND DISLODGEMENT OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED RIGHT CORONARY ARTERY (RCA). THE LESION WAS PRE-DILATED RESULTING IN 80% RESIDUAL STENOSIS. AS THE 4.0X32MM PROMUS ELEMENT PLUS STENT WAS ADVANCED PAST THE GUIDE CATHETER TIP THE DEVICE WOULD ENCOUNTER RESISTANCE AND BE PUSHED BACK INTO THE GUIDE CATHETER LUMEN. DUE TO INTERACTION WITH THE TIP OF THE GUIDE CATHETER THE STENT WAS SHORTENED AND FLARED AND WOULD NO LONGER ENTER TO GUIDE CATHETER LUMEN. THE GUIDE CATHETER AND STENT SYSTEM WERE REMOVED WITH THE WIRE IN PLACE, HOWEVER THE STENT DISLODGED BUT REMAINED ON THE WIRE. THE DISLODGED STENT WAS SNARED AND REMOVED FROM THE PATENT. THE PROCEDURE WAS COMPLETED WITH TWO ADDITIONAL PROMUS ELEMENT STENTS. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS FINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED VIA JOURNAL ARTICLE. ASPIRATION THROMBECTOMY AND BALLOON DILATATION WERE PERFORMED, RESULTING IN TIMI GRADE-3 FLOW AND IDENTIFICATION OF UNDERLYING RUPTURED PLAQUE IN THE PROXIMAL TO MID RCA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116459 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493911432400 15224599

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention GUIDEWIRE: SHORT PROWATER| GUIDE CATHETER: 6F AR FORCE MEDTRONIC