BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3202540 · Received July 2, 2013

    Report

    Report Number
    2134265-2013-04627
    Event Type
    Malfunction
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE FOUND THE DEVICE WAS RETURNED TO THE COMPLAINT INVESTIGATION SITE WITH THE STENT DISLODGED FROM THE BALLOON AND RESTING ON THE LUMEN OF THE DEVICE. THE BALLOON WAS FOUND TO HAVE THE STENT IMPRESSIONS ON IT AND PILLOWING OF THE BALLOON INDICATING THAT THE STENT WAS CRIMPED PER PROCESS IN THE CORRECT LOCATION DURING MANUFACTURING. THE STENT WAS SEVERELY DAMAGED ALONG ITS LENGTH. THE BALLOON WAS TIGHTLY WRAPPED AND DID NOT APPEAR TO HAVE BEEN SUBJECTED TO POSITIVE PRESSURE. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    SAME CASE AS 2134265-2013-04624. 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 2134265-2013-04624. 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
    301458 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911408350 0015928939

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR