BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3180098 · Received June 20, 2013

    Report

    Report Number
    2134265-2013-04523
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT VASCULAR ACCESS WAS GAINED VIA THE RIGHT FEMORAL ARTERY WITH AN 8 FR INTRODUCER SHEATH. THE ARTERY WAS PRE-DILATED WITH A 3.0X20MM EMERGE BALLOON, AND POST-DILATION WAS PERFORMED WITH A 3.0X15MM EMERGE BALLOON.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2013-04519, 2134265-2013-04524. IT WAS REPORTED THAT DURING A CTO PROCEDURE, A VESSEL PERFORATION OCCURRED. THE CHRONIC TOTAL OCCLUSION (CTO) TARGET LESION WAS LOCATED IN THE CALCIFIED RIGHT CORONARY ARTERY (RCA). THE NON-BSC CTO CATHETER WAS INTRODUCED INTO THE ARTERY ON AN UNSPECIFIED GUIDE WIRE, AND THE GUIDE WIRE WAS RETRACTED BACK INTO THE DISTAL END OF THE CATHETER AND VIA THE SPINNING TECHNIQUE THE ATTEMPT WAS MADE TO INTRODUCE THE CATHETER INTO THE POXIMAL CAP OF THE LESION. IT WAS NOTED THAT THE CATHETER WAS TRACKING INTO A SIDE BRANCH OF THE VESSEL. A NON BSC GUIDE WIRE WAS INTRODUCED INTO THE CATHETER IN AN ATTEMPT TO REDIRECT THE CATHETER TO THE MAIN VESSEL LUMEN. NUMEROUS ATTEMPTS WERE MADE WITH THE CATHETER AND TWO NON-BSC GUIDE WIRES (IN A KNUCKLE FASHION), AND ULTIMATELY THE CATHETER TRACKED TO THE DISTAL VESSEL PAST THE CTO LESION VIA THE SUB-INTIMAL SPACE. AT THIS TIME A RETROGRADE ANGIOGRAM WAS PERFORMED FOR DEVICE PLACEMENT, THIS SHOWED A SMALL CONTAINED STAIN AT THE AREA OF THE SIDE BRANCH. THE PATIENT WAS STABLE AND WITH THIS BEING A SMALL CONTAINED STAIN THE DECISION WAS MADE TO CONTINUE THE PROCEDURE. THE CATHETER WAS EXCHANGED FOR ANOTHER NON-BSC CTO CATHETER AND USING A NON-BSC CTO GUIDE WIRE RE-ENTRY WAS MADE TO THE TRUE LUMEN OF THE VESSEL. DURING POSITIONING OF THE CATHETER AND RE-ENTRY, RETROGRADE CONTRAST INJECTIONS WERE PERFORMED FOR DEVICE PLACEMENT, THERE WAS NO NOTICE DURING THESE INJECTIONS OF THE STAIN THAT WAS SEEN BEFORE. AFTER TRUE LUMEN PLACEMENT OF A GUIDE WIRE WAS ACHIEVED, THE ARTERY WAS PRE-DILATED WITH AN UNSPECIFIED BALLOON IN PREPARATION FOR STENT PLACEMENT AND 3 PROMUS ELEMENT PLUS STENTS WERE DEPLOYED FROM THE PROXIMAL ARTERY TO THE DISTAL ARTERY. AT THIS TIME AN ANTEGRADE CONTRAST INJECTION WAS PERFORMED WHICH SHOWED A LARGE PERFORATION WITH CONTRAST EXTRAVASATION IN THE GENERAL AREA OF THE STAIN THAT WAS NOTED EARLIER IN THE PROCEDURE. A DILATATION BALLOON WAS POSITIONED AT THE PERFORATION SITE AND INFLATED TO TAMPONADE THE PERFORATION AFTER THIS A 3.0 NON-BSC COVERED STENT WAS DEPLOYED WITH DIFFICULTY TO THE SITE WHICH SEALED THE PERFORATION. AN ECHOCARDIOGRAPHY PERFORMED WAS INCONCLUSIVE FOR ANY EFFUSION. DURING THE EVENT THE PATIENT REMAINED STABLE WITH NO ADVERSE EFFECTS NOTED. THE PATIENT HAD REMAINED STABLE POST-PROCEDURE AND OVERNIGHT AND WAS SCHEDULED FOR DISCHARGE TO HOME ON THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280625 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911438300 0015938478

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PILOT 200 GUIDE WIRE| FIELDER XT GUIDE WIRE| BRIDGEPOINT CROSSBOSS CATHETER