BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2220655 · Received August 23, 2011

    Report

    Report Number
    2134265-2011-03575
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 PROXIMAL STENT DAMAGE. STRUTS AT THE PROXIMAL END OF THE STENT WERE MISALIGNED AND DAMAGED. THE HYPOTUBE WAS BROKEN 145MM DISTAL TO THE CATHETER STRAIN RELIEF. THE HYPOTUBE WAS KINKED ALONG ITS ENTIRE LENGTH. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE SYSTEM. SOLIDIFIED BLOOD WAS PRESENT WITHIN THE GUIDEWIRE LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN USED IN VIVO. THE TIP AND BALLOON SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. A PRODUCT MANDREL WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. 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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE A SHAFT BREAK OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE COMPLETE TOTALLY OCCLUDED RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN ADVANCED A NON-BSC GUIDE WIRE AND A NON-BSC GUIDE CATHETER TO THE TARGET LESION. SEVERAL BALLOON INFLATIONS WERE PERFORMED FOR 10 SECONDS EACH AT 10 TO 14 ATMS IN THE PROXIMAL AND MID RCA USING 2.0X20MM AND 2.5X30MM MAVERICK BALLOON CATHETERS. THE PHYSICIAN DEPLOYED A 1.25X10MM NON-BSC STENT IN THE MID RCA AT 14ATMS FOR 10 SECONDS, FOLLOWED BY A 1.5X15MM NON BSC STENT DEPLOYED AT 10ATMS FOR 10 SECONDS. SEVERAL MORE BALLOON INFLATIONS WERE PERFORMED FOR 10 SECONDS EACH AT 10 TO 22 ATMS IN THE MID RCA USING 2.5X15MM, 2.5X20MM AND 2.75X15MM QUANTUM MAVERICK BALLOON CATHETERS AND 1.2X15MM AND 2.0X12MM NON-BSC BALLOON CATHETERS. THE PHYSICIAN TRIED TO ADVANCE A 2.25X32MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) TO THE MID RCA, HOWEVER THERE WAS DIFFICULTY CROSSING THE LESION AND THE SDS SHAFT BROKE OUTSIDE OF THE GUIDE CATHETER. THE SDS WAS SUCCESSFULLY REMOVED AND A 2.5X38MM PROMUS ELEMENT SDS WAS DEPLOYED. SEVERAL MORE BALLOON INFLATIONS AND 6 MORE PROMUS ELEMENT STENTS SIZES 3.5X16MM, 3.5X28MM, 2.5X38MM, 3.0X16MM, 3.5X8MM AND A 4.0X12MM WERE DEPLOYED IN THE PROXIMAL AND MID RCA. THE PATIENT WAS PLACED ON ASA AND PLAVIX FOR 12 MONTHS. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A SHAFT BREAK OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE COMPLETE TOTALLY OCCLUDED RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN ADVANCED A NON-BSC GUIDE WIRE AND A NON-BSC GUIDE CATHETER TO THE TARGET LESION. SEVERAL BALLOON INFLATIONS WERE PERFORMED FOR 10 SECONDS EACH AT 10 TO 14 ATMS IN THE PROXIMAL AND MID RCA USING 2.0X20MM AND 2.5X30MM MAVERICK BALLOON CATHETERS. THE PHYSICIAN DEPLOYED A 1.25X10MM NON-BSC STENT IN THE MID RCA AT 14ATMS FOR 10 SECONDS, FOLLOWED BY A 1.5X15MM NON BSC STENT DEPLOYED AT 10ATMS FOR 10 SECONDS. SEVERAL MORE BALLOON INFLATIONS WERE PERFORMED FOR 10 SECONDS EACH AT 10 TO 22 ATMS IN THE MID RCA USING 2.5X15MM, 2.5X20MM AND 2.75X15MM QUANTUM MAVERICK BALLOON CATHETERS AND 1.2X15MM AND 2.0X12MM NON-BSC BALLOON CATHETERS. THE PHYSICIAN TRIED TO ADVANCE A 2.25X32MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) TO THE MID RCA, HOWEVER, THERE WAS DIFFICULTY CROSSING THE LESION AND THE SDS SHAFT BROKE OUTSIDE OF THE GUIDE CATHETER. THE SDS WAS SUCCESSFULLY REMOVED AND A 2.5X38MM PROMUS ELEMENT SDS WAS DEPLOYED. SEVERAL MORE BALLOON INFLATIONS AND 6 MORE PROMUS ELEMENT STENTS SIZES 3.5X16MM, 3.5X28MM, 2.5X38MM, 3.0X16MM, 3.5X8MM AND A 4.0X12MM WERE DEPLOYED IN THE PROXIMAL AND MID RCA. THE PATIENT WAS PLACED ON ASA AND PLAVIX FOR 12 MONTHS. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911332220 0014349959

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR 2.0X12MM MINI TREK BALLOON CATHETER| 2.5X20MM MAVERICK BALLOON CATHETER| TANZUNA 1.25X10MM STENT| 2.75X15MM QUANTUM MAVERICK BALLOON CATHETER| 2.0X20MM MAVERICK BALLOON CATHETER| 2.5X30MM MAVERICK BALLOON CATHETER| 1.2X15MM MINI TREK BALLOON CATHETER| TANZUNA 1.2X15MM STENT| 2.5X15MM QUANTUM MAVERICK BALLOON CATHETER| FINECROSS GUIDE CATHETER| FIELDER XT GUIDE WIRE