BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3202587 · Received July 2, 2013

    Report

    Report Number
    2134265-2013-04624
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: ONLY THE STENT OF THIS DEVICE WAS RETURNED. THERE WAS LIMITED DAMAGE TO THE STENT. STRUTS ON ONE ROW AT THE CENTER OF THE STENT WERE BUNCHED UP. SOME STRUTS ON ANOTHER ROW TOWARDS THE CENTER OF THE STENT WERE MISALIGNED. 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

    SAME CASE AS 2134265-2013-04627. IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, STENT DISLODGMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX AND OBTUSE MARGINAL (OM). AN UNSPECIFIED STENT HAD ALREADY BEEN PLACED IN THE CIRCUMFLEX ARTERY CROSSED OVER THE OBTUSE MARGINAL. THE PHYSICIAN WAS IN THE PROCESS WHERE HE ALREADY REWIRED THE OM THROUGH THE STENT STRUTS AND HE HAD BALLOONED IT OPEN. A 4.00 X 16 MM PROMUS ELEMENT PLUS WAS ADVANCED INTO THE OSTIUM OF THE OM USING A MINI CRUSH STENT TECHNIQUE INTO THE OM. THEY WERE USING TWO WIRES (ONE WIRE DOWN THE CIRCUMFLEX AND ONE WIRE DOWN THE OM) AND AN UNSPECIFIED BALLOON ON THE CIRCUMFLEX WIRE, ALL IN A 6F SYSTEM. AS THE PHYSICIAN WAS PASSING THE 4 X 16 STENT THROUGH THE GUIDE INTO THE ARTERY AND AS THE STENT DELIVERY SYSTEM CAME OUT OF THE GUIDE AND INTO THE ARTERY, HE NOTICED THAT THERE WAS NO STENT ON THE STENT DELIVERY SYSTEM, IT CAME OFF IN THE GUIDE CATHETER. EVERYTHING WAS IN THE BODY AND INSIDE THE GUIDE CATHETER, SO THE DOCTOR HAD TO REMOVE THE GUIDE AND THE 2 WIRES WITH THE STENT DELIVERY SYSTEM AND THE BALLOON CATHETER, ALL AT ONE TIME TO PREVENT THE STENT FROM COMING OUT OF THE GUIDE AND KEEPING THE STENT IN THE GUIDE CATHETER. NO INFORMATION IF THE STENT WAS PULLED OUT FROM THE GUIDE OR THROWN AWAY. THEY HAD TO RE-ACCESS THE ARTERY WITH AN UNSPECIFIED GUIDE CATHETER, REWIRED THE OM ARTERY AND THE CIRCUMFLEX ARTERY AND WAS ABLE TO USED ANOTHER STENT OF THE SAME SIZE AND MODEL WITH NO PATIENT COMPLICATION. AT THIS POINT IN TIME, THE DOCTOR WAS STENTING THE OSTIUM OF THE CIRCUMFLEX ARTERY, PROXIMAL TO THE TWO STENTS THAT HE PREVIOUSLY PLACED. AS THEY REMOVED THE STYLET, THEY PULLED OFF THE 3.5 X 8 PROMUS ELEMENT PLUS STENT WITH THE STYLET. THE STENT CAME OFF IN THE DELIVERY SYSTEM, IT NEVER WENT INTO THE PATIENT'S BODY. USED A SECOND 3.5 X 8 PROMUS ELEMENT TO STENT THE PROXIMAL CIRCUMFLEX THEN COMPLETED THE CASE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    SAME CASE AS 2134265-2013-04627. IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, STENT DISLODGMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX AND OBTUSE MARGINAL (OM). AN UNSPECIFIED STENT HAD ALREADY BEEN PLACED IN THE CIRCUMFLEX ARTERY CROSSED OVER THE OBTUSE MARGINAL. THE PHYSICIAN WAS IN THE PROCESS WHERE HE ALREADY REWIRED THE OM THROUGH THE STENT STRUTS AND HE HAD BALLOONED IT OPEN. A 4.00 X 16 MM PROMUS ELEMENT¿ PLUS WAS ADVANCED INTO THE OSTIUM OF THE OM USING A MINI CRUSH STENT TECHNIQUE INTO THE OM. THEY WERE USING TWO WIRES (ONE WIRE DOWN THE CIRCUMFLEX AND ONE WIRE DOWN THE OM) AND AN UNSPECIFIED BALLOON ON THE CIRCUMFLEX WIRE, ALL IN A 6F SYSTEM. AS THE PHYSICIAN WAS PASSING THE 4 X 16 STENT THROUGH THE GUIDE INTO THE ARTERY AND AS THE STENT DELIVERY SYSTEM CAME OUT OF THE GUIDE AND INTO THE ARTERY, HE NOTICED THAT THERE WAS NO STENT ON THE STENT DELIVERY SYSTEM, IT CAME OFF IN THE GUIDE CATHETER. EVERYTHING WAS IN THE BODY AND INSIDE THE GUIDE CATHETER, SO THE DOCTOR HAD TO REMOVE THE GUIDE AND THE 2 WIRES WITH THE STENT DELIVERY SYSTEM AND THE BALLOON CATHETER, ALL AT ONE TIME TO PREVENT THE STENT FROM COMING OUT OF THE GUIDE AND KEEPING THE STENT IN THE GUIDE CATHETER. NO INFORMATION IF THE STENT WAS PULLED OUT FROM THE GUIDE OR THROWN AWAY. THEY HAD TO RE-ACCESS THE ARTERY WITH AN UNSPECIFIED GUIDE CATHETER, REWIRED THE OM ARTERY AND THE CIRCUMFLEX ARTERY AND WAS ABLE TO USED ANOTHER STENT OF THE SAME SIZE AND MODEL WITH NO PATIENT COMPLICATION. AT THIS POINT IN TIME, THE DOCTOR WAS STENTING THE OSTIUM OF THE CIRCUMFLEX ARTERY, PROXIMAL TO THE TWO STENTS THAT HE PREVIOUSLY PLACED. AS THEY REMOVED THE STYLET, THEY PULLED OFF THE 3.5 X 8 PROMUS ELEMENT¿ PLUS STENT WITH THE STYLET. THE STENT CAME OFF IN THE DELIVERY SYSTEM, IT NEVER WENT INTO THE PATIENT'S BODY. USED A SECOND 3.5 X 8 PROMUS ELEMENT TO STENT THE PROXIMAL CIRCUMFLEX THEN COMPLETED THE CASE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301168 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911416400 15865367

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention