BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOS

    MDR report key: 20750387 · Received November 21, 2024

    Report

    Report Number
    3005099803-2024-05763
    Event Type
    Malfunction
    Date Received
    November 21, 2024
    Date of Event
    October 25, 2024
    Report Date
    December 2, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    UDI-DI
    08714729951179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B5 HAS BEEN UPDATED WITH THE ADDITIONAL INFORMATION RECEIVED ON NOVEMBER 8, 2024. BLOCK D2B: PRO CODE (PRODUCT CODE): KNS, PCU; REPORTED HERE AS THE PRODUCT CODE EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G4: PREMARKET/510(K): K163272, K181905, K220112, K233318; REPORTED HERE AS THE PRODUCT CODE EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A0106 CAPTURES THE REPORTABLE EVENT OF STENT OBSTRUCTION WITHIN DEVICE. IMDRF DEVICE CODE A04 CAPTURES THE REPORTABLE EVENT OF STENT COVER DAMAGED.

    Additional Manufacturer Narrative · 0

    BLOCK D2B: PRO CODE (PRODUCT CODE): KNS, PCU; REPORTED HERE AS THE PRODUCT CODE EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G4: PREMARKET/510(K): K163272, K181905, K220112, K233318; REPORTED HERE AS THE PRODUCT CODE EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A0106 CAPTURES THE REPORTABLE EVENT OF STENT OBSTRUCTION WITHIN DEVICE. IMDRF DEVICE CODE A04 CAPTURES THE REPORTABLE EVENT OF STENT COVER DAMAGED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS IMPLANTED IN THE PANCREAS FOR THE TREATMENT OF WALLED-OFF-NECROSIS (WON) DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ON (B)(6) 2024, APPROXIMATELY 4 WEEKS POST STENT PLACEMENT PROCEDURE, THE REMOVAL OF THE AXIOS STENT WENT SMOOTHLY, ALTHOUGH THERE WAS SLIGHT RESISTANCE THAN USUAL. THE STENT WAS REMOVED WITH A SMALL AMOUNT OF TISSUE INGROWTH WHICH WAS FOUND NEAR THE EDGE OF THE FLANGE ON THE FLUID COLLECTION SIDE, AND THERE WAS EVIDENCE OF DEGRADATION OF THE STENT COVER. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON NOVEMBER 8, 2024. IT WAS REPORTED THAT THE AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS IMPLANTED TRANSGASTRIC TO THE PANCREAS DURING A CYSTGASTROSTOMY PROCEDURE. ADDITIONALLY, THE STENT REMOVAL PROCEDURE WAS A SCHEDULED REMOVAL, AND THE INDICATION WAS RESOLVED AT THE TIME OF REMOVAL. A GRASPER FORCEPS WAS USED TO REMOVE THE STENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS IMPLANTED IN THE PANCREAS FOR THE TREATMENT OF WALLED-OFF-NECROSIS (WON) DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ON (B)(6) 2024, APPROXIMATELY 4 WEEKS POST STENT PLACEMENT PROCEDURE, THE REMOVAL OF THE AXIOS STENT WENT SMOOTHLY, ALTHOUGH THERE WAS SLIGHT RESISTANCE THAN USUAL. THE STENT WAS REMOVED WITH A SMALL AMOUNT OF TISSUE INGROWTH WHICH WAS FOUND NEAR THE EDGE OF THE FLANGE ON THE FLUID COLLECTION SIDE, AND THERE WAS EVIDENCE OF DEGRADATION OF THE STENT COVER. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1787182 AXIOS UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION M00553660 0034261802 08714729951179

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown