BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 3002143 · Received March 13, 2013

    Report

    Report Number
    2134265-2013-01396
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE FOUND THE DEVICE WAS RETURNED WITH THE STENT DISLODGED FROM THE BALLOON. THE STENT WAS NOT RETURNED. THE DEVICE WAS RETURNED IN A CURLED UP LIKE SHAPE. FROM THE CONDITION OF THE BALLOON IT WAS NOT POSSIBLE TO SEE THE CRIMP MARKS CLEARLY. SOLIDIFIED CONTRAST MEDIA /BLOOD WAS PRESENT WITHIN THE ENTIRE LENGTH OF THE INFLATION LUMEN AND THE BALLOON, THEREFORE INDICATING THE DEVICE HAD BEEN PREPPED FOR USE. THE BALLOON WAS NOT TIGHTLY WRAPPED AND WAS SUBJECTED TO POSITIVE PRESSURE. THE HYPOTUBE WAS KINKED AT 320MM AND 520MM DISTAL TO THE STRAIN RELIEF. SEVERAL SMALLER KINKS WERE ALSO NOTED ALONG THE LENGTH OF THE DEVICE. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED TIP DAMAGE (JAGGED LIKE EDGE). THIS TYPE OF DAMAGE IS CONSISTENT WITH THE TIP BEING PUSHED UP AGAINST A RESTRICTION, DURING ATTEMPTS TO CROSS THE LESION. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. 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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED DISTAL RIGHT CORONARY ARTERY. A NON BSC GUIDE WIRE WAS ADVANCED TO THE TARGET LESION AND PRE DILATION WAS PERFORMED WITH AN UNKNOWN BALLOON CATHETER, TO UNKNOWN ATMS. A 2.50X16MM PROMUS ELEMENT - STENT DELIVERY SYSTEM WAS ADVANCED TO THE TARGET LESION, CAME INTO CONTACT WITH THE TORTUOUS REGION OF THE RCA AND WAS UNABLE TO CROSS THE TARGET LESION. WITH THE PROMUS ELEMENT SDS REMAINING AT THE TARGET LESION, A BUDDY GUIDE WIRE WAS ADVANCED VIA A 7F 1.5 NON BSC GUIDE CATHETER. THE PROMUS ELEMENT SDS WAS THEN ADVANCED TO THE TARGET LESION. THE PROMUS ELEMENT STENT WAS DILATED AND THE PHYSICIAN BELIEVED THAT THE STENT HAD DISLODGED. THE PROMUS ELEMENT SDS WAS REMOVED. AN ATLANTIS SR IMAGING CATHETER WAS INSERTED BUT ENCOUNTER RESISTANCE AT THE Y THE CONNECTOR AND THE DEVICE WAS UNABLE TO ADVANCE. THE ATLANTIS SR WAS REMOVED AND IT WAS NOTED THAT THE TIP WAS BENT. ANOTHER ATLANTIS SR IMAGING CATHETER WAS ADVANCED TO THE TARGET LESION AND IT WAS NOTED THAT THE PROMUS ELEMENT STENT HAD DETACHED IN THE PROXIMAL RCA AND THE LENGTH WAS SHORTEN HALFWAY. AN ATTEMPT TO RETRIEVE THE PROMUS ELEMENT STENT WAS UNSUCCESSFUL. A 2.5-12MM AND A 3.5-12MM NON BSC BALLOON CATHETER WERE ADVANCED AND DILATED TO "CRUSH" THE STENT INSIDE THE PROXIMAL RCA. NEXT, A 3.5X12MM NON BSC STENT WAS IMPLANTED AT THE PROXIMAL RCA. TO COMPLETE THE PROCEDURE, A 3.5X12MM NON BSC STENT WAS IMPLANTED AT THE TARGET LESION. AN IVUS WAS PERFORMED AND THE PROCEDURE WAS COMPLETED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED A FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED DISTAL RIGHT CORONARY ARTERY. A NON BSC GUIDE WIRE WAS ADVANCED TO THE TARGET LESION AND PRE DILATION WAS PERFORMED WITH AN UNKNOWN BALLOON CATHETER, TO UNKNOWN ATMS. A 2.50X16MM PROMUS ELEMENT - STENT DELIVERY SYSTEM WAS ADVANCED TO THE TARGET LESION, CAME INTO CONTACT WITH THE TORTUOUS REGION OF THE RCA AND WAS UNABLE TO CROSS THE TARGET LESION. WITH THE PROMUS ELEMENT SDS REMAINING AT THE TARGET LESION, A BUDDY GUIDE WIRE WAS ADVANCED VIA A 7F 1.5 NON BSC GUIDE CATHETER. THE PROMUS ELEMENT SDS WAS THEN ADVANCED TO THE TARGET LESION. THE PROMUS ELEMENT STENT WAS DILATED AND THE PHYSICIAN BELIEVED THAT THE STENT HAD DISLODGED. THE PROMUS ELEMENT SDS WAS REMOVED. AN ATLANTIS SR IMAGING CATHETER WAS INSERTED BUT ENCOUNTER RESISTANCE AT THE Y THE CONNECTOR AND THE DEVICE WAS UNABLE TO ADVANCE. THE ATLANTIS SR WAS REMOVED AND IT WAS NOTED THAT THE TIP WAS BENT. ANOTHER ATLANTIS SR IMAGING CATHETER WAS ADVANCED TO THE TARGET LESION AND IT WAS NOTED THAT THE PROMUS ELEMENT STENT HAD DETACHED IN THE PROXIMAL RCA AND THE LENGTH WAS SHORTEN HALFWAY. AN ATTEMPT TO RETRIEVE THE PROMUS ELEMENT STENT WAS UNSUCCESSFUL. A 2.5-12MM AND A 3.5-12MM NON BSC BALLOON CATHETER WERE ADVANCED AND DILATED TO "CRUSH" THE STENT INSIDE THE PROXIMAL RCA. NEXT, A 3.5X12MM NON BSC STENT WAS IMPLANTED AT THE PROXIMAL RCA. TO COMPLETE THE PROCEDURE, A 3.5X12MM NON BSC STENT WAS IMPLANTED AT THE TARGET LESION. AN IVUS WAS PERFORMED AND THE PROCEDURE WAS COMPLETED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED A FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105565 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911316250 14981168

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDE CATHETER, BRITETIP 7FR 1.5SH