BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND DELIVERY SYSTEM

    MDR report key: 7084707 · Received December 5, 2017

    Report

    Report Number
    3005099803-2017-03575
    Event Type
    Injury
    Date Received
    December 5, 2017
    Date of Event
    November 9, 2017
    Report Date
    November 9, 2017
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    PCU
    UDI-DI
    08714729904588
    PMA / PMN Number
    K150692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A HOT AXIOS DELIVERY SYSTEM WAS RECEIVED FOR ANALYSIS; THE STENT WAS NOT RETURNED. A VISUAL EVALUATION OF THE DEVICE NOTED THAT THE STENT DEPLOYMENT HUB WAS LOCKED AT STEP 2, AND THE OUTER SHEATH WAS NOTED TO BE KINKED. THERE WERE NO OTHER ISSUES WITH THE DEVICE. THE INVESTIGATION CONCLUDED THAT THE CAUSE OF THE REPORTED EVENT AND THE NOTED DEVICE DEFECTS WAS MOST PROBABLY DUE TO ANATOMICAL OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, WHICH LIMITED THE PERFORMANCE OF THE DEVICE. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A SEARCH OF THE COMPLAINT DATABASE CONFIRMED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2017-03575 PERTAINS TO THE FIRST AXIOS DEVICE AND MANUFACTURER REPORT # 3005099803-2017-03576 PERTAINS TO THE SECOND AXIOS DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HOT AXIOS STENT WAS TO BE IMPLANTED IN A TRANSDUODENAL POSITION TO TREAT A PANCREATIC PSEUDOCYST DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST AXIOS STENT WAS INADVERTENTLY FULLY DEPLOYED IN THE PATIENT'S DUODENUM. THE STENT WAS REMOVED FROM THE PATIENT WITH FORCEPS. PLACEMENT OF A SECOND AXIOS STENT WAS THEN ATTEMPTED; HOWEVER, THE SECOND AXIOS STENT WAS ALSO INADVERTENTLY FULLY DEPLOYED IN THE PATIENT'S DUODENUM. THE STENT WAS REMOVED FROM THE PATIENT WITH FORCEPS AND THE PROCEDURE WAS COMPLETED BY DRAINING THE PSEUDOCYST WITH A FINE NEEDLE ASPIRATION (FNA) NEEDLE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE OKAY.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2017-03575 PERTAINS TO THE FIRST AXIOS DEVICE AND MANUFACTURER REPORT # 3005099803-2017-03576 PERTAINS TO THE SECOND AXIOS DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HOT AXIOS STENT WAS TO BE IMPLANTED IN A TRANSDUODENAL POSITION TO TREAT A PANCREATIC PSEUDOCYST DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST AXIOS STENT WAS INADVERTENTLY FULLY DEPLOYED IN THE PATIENT'S DUODENUM. THE STENT WAS REMOVED FROM THE PATIENT WITH FORCEPS. PLACEMENT OF A SECOND AXIOS STENT WAS THEN ATTEMPTED; HOWEVER, THE SECOND AXIOS STENT WAS ALSO INADVERTENTLY FULLY DEPLOYED IN THE PATIENT'S DUODENUM. THE STENT WAS REMOVED FROM THE PATIENT WITH FORCEPS AND THE PROCEDURE WAS COMPLETED BY DRAINING THE PSEUDOCYST WITH A FINE NEEDLE ASPIRATION (FNA) NEEDLE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864222 AXIOS STENT AND DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC - GALWAY M00553640 20222652 08714729904588

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention