BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2862312 · Received December 10, 2012

    Report

    Report Number
    2134265-2012-07432
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 7, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER: DEVICE WAS NOT RECEIVED FOR 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 DURING A CORONARY STENTING TREATMENT PROCEDURE, STENT DISLODGEMENT OCCURRED. ACCESS WAS OBTAINED VIA FEMORAL ARTERY. THE SEVERELY TORTUOUS AND CALCIFIED LESION WAS LOCATED IN THE PROXIMAL CIRCUMFLEX (CX) AND ACCESSED VIA A SEVERELY CALCIFIED LEFT MAIN CORONARY ARTERY (LMCA). USING A NON-BSC GUIDE CATHETER, THE LESION WAS PRE-DILATED WITH A NON-BSC BALLOON CATHETER BUT THE 4.00 X16 MM PROMUS ELEMENT PLUS STENT WOULD NOT CROSS THE LESION. SEVERAL ATTEMPTS WERE MADE TO CROSS THE LESION BUT THEY DID NOT HAVE GOOD SUPPORT. USING A DIFFERENT GUIDE CATHETER, THEY MADE SEVERAL MORE ATTEMPTS TO CROSS THE LESION BUT WERE UNSUCCESSFUL. WHILE REMOVING THE 4.00 X16 MM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM, CALCIUM PULLED THE STENT OFF THE DELIVERY BALLOON BUT THE STENT REMAINED ON THE GUIDEWIRE. THE DELIVERY BALLOON WAS REMOVED WITH THE GUIDEWIRE LEFT IN PLACE. THEY ADVANCED A NON-BSC BALLOON CATHETER JUST PAST THE DISLODGED STENT, EXPANDED THE BALLOON, AND SUCCESSFULLY PULLED THE BALLOON BACK ENOUGH TO BRING THE DISLODGED STENT TO THE MID-FOREARM INSIDE THE GUIDE CATHETER. THE STENT GOT STUCK IN THE GUIDE CATHETER. THEY REMOVED THE GUIDE CATHETER AND THE SHEATH. USING A 2.0 X 8 MM EMERGE BALLOON CATHETER, THEY ADVANCED THE BALLOON CATHETER PAST THE STENT AND INFLATED IT IN AN ATTEMPT TO PULL THE STENT BACK OUT THROUGH THE ARTERY, HOWEVER THEY WERE UNSUCCESSFUL. THE DISLODGED STENT REMAINS IN THE PATIENT'S DISTAL WRIST, ALMOST TO THE HAND, UNINFLATED. VASCULAR SURGEON STATED, DURING CONSULT, THAT "IT IS BETTER TO LEAVE IT IN THE BODY. THE PHYSICIAN SCHEDULED ANOTHER PROCEDURE THAT AFTERNOON, TO TREAT THE PROXIMAL CX LESION. PATIENT RETURNED TO THE CATH LAB LATER THE SAME DAY. ACCESS WAS OBTAINED VIA FEMORAL ARTERY AND A 4.00 X16 MM PROMUS ELEMENT PLUS STENT WAS ADVANCED BUT UNABLE TO CROSS THE PROXIMAL CX LESION. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911416400 14941267

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BALLOON CATHETER: 2.0X8 EMERGE| GUIDE CATHETER: EBU 3.75 LAUNCHER - MEDTRONIC| BALLOON CATHETER: 1.5X10 SPRINTER| BALLOON CATHETER: 3.0X12 SPRINTER LEGEND