BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS LD ILIAC/BILIARY PREMOUNTED STENT SYSTEM

    MDR report key: 2020270 · Received March 16, 2011

    Report

    Report Number
    2134265-2011-00686
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIO
    PMA / PMN Number
    P090003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED DEVICE ANALYSIS REVEALED THE STENT WAS NOT ON THE BALLOON. THERE WAS NO DAMAGE NOTED TO THE SHAFT OF THE DEVICE. THE BALLOON WAS FOLDED AND WRAPPED AROUND THE SHAFT. A CLEAR IMPRESSION OF WHERE THE STENT WAS ORIGINALLY CRIMPED WAS VISIBLE ON THE BALLOON MATERIAL. THERE WERE TRACES OF BLOOD VISIBLE ON THE STENT. VISUAL AND MICROSCOPIC EXAMINATION OF THE STENT OBSERVED THAT SOME OF THE STRUTS ON ONE END OF THE STENT WERE PUSHED APART AND LIFTED UP AND THE STENT WAS FLATTENED ON THE OTHER END. THERE WAS A SMALL SECTION OF HUMAN TISSUE WRAPPED AROUND THE STENT. NO FURTHER PRODUCT ANALYSIS WAS PERFORMED AT THIS TIME. 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

    AGE AT TIME OF EVENT: (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL STENTING TREATMENT PROCEDURE, THE STENT BECAME DISLODGED FROM THE DELIVERY SYSTEM. VASCULAR ACCESS WAS OBTAINED NEAR LIVER. THE TARGET LESION WAS A STRICTURE LOCATED IN THE LOWER BILE DUCT. A NON BSC GUIDE WIRE WAS PLACED INSIDE THE PATIENT. THE 8.0X60MM EXPRESS LD STENT DELIVERY SYSTEM (SDS) WAS ADVANCED OVER THE WIRE. WHEN THE SDS WAS APPROXIMATELY 15CM FROM THE DISTAL TIP OF THE WIRE, IT WAS NOTED THAT THE WIRE WAS BENT. THE EXPRESS LD SDS WAS REMOVED AND REINSERTED FROM ANOTHER ANGLE VIA THE SAME ACCESS SITE. WHILE REINSERTING, THE EXPRESS LD STENT DISLODGED FROM THE SDS INSIDE THE PATIENT AND REMAINED ON THE GUIDE WIRE. A FORCEPS WAS USED TO REMOVE THE STENT FROM THE PATIENT. A SMALL AMOUNT OF BLEEDING WAS NOTED AT THE ACCESS SITE, BUT DID NOT REQUIRE TREATMENT. AS ORIGINALLY PLANNED, A PERCUTANEOUS TRANSHEPATIC CHOLANGIODRAINAGE (PTCD) TUBE WAS IMPLANTED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS NOTED AND THE PHYSICIAN HAD DECIDED TO TAKE A WAIT AND SEE APPROACH. FIVE DAYS POST PROCEDURE, A SECOND PTCD TUBE WAS IMPLANTED AND THE ORIGINAL STRICTURE WAS TREATED WITH IMPLANTATION OF A 8.0X60MM EXPRESS LD STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL STENTING TREATMENT PROCEDURE, THE STENT BECAME DISLODGED FROM THE DELIVERY SYSTEM. VASCULAR ACCESS WAS OBTAINED 'NEAR LIVER'. THE TARGET LESION WAS A STRICTURE LOCATED IN THE LOWER BILE DUCT. A NON BSC GUIDE WIRE WAS PLACED INSIDE THE PATIENT. THE 8.0X60MM EXPRESS LD STENT DELIVERY SYSTEM (SDS) WAS ADVANCED OVER THE WIRE. WHEN THE SDS WAS APPROXIMATELY 15CM FROM THE DISTAL TIP OF THE WIRE, IT WAS NOTED THAT THE WIRE WAS BENT. THE EXPRESS LD SDS WAS REMOVED AND REINSERTED FROM 'ANOTHER ANGLE' VIA THE SAME ACCESS SITE. WHILE REINSERTING, THE EXPRESS LD STENT DISLODGED FROM THE SDS INSIDE THE PATIENT AND REMAINED ON THE GUIDE WIRE. A FORCEPS WAS USED TO REMOVE THE STENT FROM THE PATIENT. A SMALL AMOUNT OF BLEEDING WAS NOTED AT THE ACCESS SITE, BUT DID NOT REQUIRE TREATMENT. AS ORIGINALLY PLANNED, A PERCUTANEOUS TRANSHEPATIC CHOLANGIODRAINAGE (PTCD) TUBE WAS IMPLANTED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS NOTED AND THE PHYSICIAN HAD DECIDED TO TAKE A 'WAIT AND SEE APPROACH'. FIVE DAYS POST PROCEDURE, A SECOND PTCD TUBE WAS IMPLANTED AND THE ORIGINAL STRICTURE WAS TREATED WITH IMPLANTATION OF A 8.0X60MM EXPRESS LD STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS LD ILIAC/BILIARY PREMOUNTED STENT SYSTEM STENT, ILIAC NIO BOSTON SCIENTIFIC - GALWAY H74938046860750 13416588

    Patients

    Seq Age Sex Outcome Treatment
    1 Other COOK MEDICAL AMPLATZ GUIDE WIRE