BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS¿ LD VASCULAR

    MDR report key: 2838308 · Received November 19, 2012

    Report

    Report Number
    2134265-2012-06956
    Event Type
    Injury
    Date Received
    November 19, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 25, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    UPN-SEARCH CORRECTED FROM UNK143 TO H74938162620750. BRAND NAME CORRECTED FROM EXPRESS LD ILIAC/BILIARY PREMOUNTED STENT SYSTEM TO EXPRESS- LD VASCULAR. COMMON DEVICE NAME CORRECTED FROM STENT, ILIAC TO CATHETER, BILIARY, DIAGNOSTIC. PRODUCT CODE CORRECTED FROM NIO TO FGE. PMA # OF 510K # CORRECTED FROM P090003 TO SIMILAR. (B)(4).

    Additional Manufacturer Narrative · 1

    UPDATED: DEVICE AVAIL. FOR EVAL., RETURNED TO MFR ON, DEVICE RETURNED TO MFR, DEVICE EVALUATED BY MFR, EVAL. SUMMARY ATTACHED, METHOD CODES, RESULT CODES, CONCLUSION CODES. DEVICE EVALUATED BY MFR: EXAMINATION OF THE RETURNED DEVICE NOTED THAT ONLY THE DELIVERY DEVICE WAS RETURNED FOR ANALYSIS. IT WAS NOTED THAT THE STENT HAD DETACHED FROM THE BALLOON AND WAS NOT RETURNED FOR ANALYSIS. IT WAS NOTED THAT THE BALLOON MATERIAL WAS FULLY DEFLATED AND CORRECTLY WRAPPED. MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL SHOWS CRIMP MARKS WHERE THE STENT HAD BEEN CRIMPED IN THE CORRECT LOCATION. A VISUAL AND TACTILE EXAMINATION OF THE SHAFT OF THE DEVICE FOUND NO ISSUES. 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 STENTING TREATMENT PROCEDURE THE STENT DISLODGED. DURING THE PROCEDURE, THE PHYSICIAN FIRST IMPLANTED TWO NON-BSC SELF EXPANDING STENTS ON THE FEMORAL ARTERY. THEN HE WANTED TO PUT AN EXPRESS LD STENT AT THE END OF THE 2 STENTS. THE EXPRESS LD STENT WENT THROUGH THE 2 OTHER STENTS WITHOUT ANY ISSUES. BUT WHEN THE PHYSICIAN TRIED TO ADJUST THE STENT PLACEMENT, IT DISLODGED. THE STENT MIGRATED (UNOPENED) TO THE POPLITEAL ARTERY. THE PHYSICIAN HAS MANAGED TO STABILIZE AND THEN OPEN IT WITH AN UNSPECIFIED BALLOON. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE STENT DISLODGED. DURING THE PROCEDURE, THE PHYSICIAN FIRST IMPLANTED TWO NON-BSC SELF EXPANDING STENTS ON THE FEMORAL ARTERY. THEN HE WANTED TO PUT AN EXPRESS LD STENT AT THE END OF THE 2 STENTS. THE EXPRESS LD STENT WENT THROUGH THE 2 OTHER STENTS WITHOUT ANY ISSUES. BUT WHEN THE PHYSICIAN TRIED TO ADJUST THE STENT PLACEMENT, IT DISLODGED. THE STENT MIGRATED (UNOPENED) TO THE POPLITEAL ARTERY. THE PHYSICIAN HAS MANAGED TO STABILIZE AND THEN OPEN IT WITH AN UNSPECIFIED BALLOON. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE THE STENT DISLODGED. DURING THE PROCEDURE, THE PHYSICIAN FIRST IMPLANTED TWO NON-BSC SELF EXPANDING STENTS ON THE FEMORAL ARTERY. THEN HE WANTED TO PUT AN EXPRESS LD STENT AT THE END OF THE 2 STENTS. THE EXPRESS LD STENT WENT THROUGH THE 2 OTHER STENTS WITHOUT ANY ISSUES. BUT WHEN THE PHYSICIAN TRIED TO ADJUST THE STENT PLACEMENT, IT DISLODGED. THE STENT MIGRATED (UNOPENED) TO THE POPLITEAL ARTERY. THE PHYSICIAN HAS MANAGED TO STABILIZE AND THEN OPEN IT WITH AN UNSPECIFIED BALLOON. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS¿ LD VASCULAR CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74938162620750 14189662

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 2 NON-BSC SELF EXPANDABLE STENTS