BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVIFLEX RX PUSHER

    MDR report key: 10385623 · Received August 10, 2020

    Report

    Report Number
    3005099803-2020-03259
    Event Type
    Injury
    Date Received
    August 10, 2020
    Date of Event
    February 1, 2016
    Report Date
    August 10, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RANGE OF AGES IN THE PLASTIC STENT GROUP WAS 32-78 YEARS OLD. IN THE PLASTIC STENT GROUP THERE WERE 13 FEMALES AND 16 MALES. IN THE PLASTIC STENT GROUP THERE WERE 1 BLACK PATIENTS, 3 HISPANIC PATIENTS, AND 25 WHITE PATIENTS. THE EVENT DATES ARE UNKNOWN. THE PROCEDURES WERE PERFORMED BETWEEN FEBRUARY 2016 AND MARCH 2017. APPROXIMATED BASED ON THE MONTH AND YEAR OF THE FIRST PROCEDURE. THE UPNS AND LOT NUMBERS WERE NOT REPORTED; THEREFORE, THE MANUFACTURE DATES AND EXPIRATION DATES ARE UNKNOWN. LITERATURE SOURCE: BANG, JI YOUNG, ET AL. "NON-SUPERIORITY OF LUMEN-APPOSING METAL STENTS OVER PLASTIC STENTS FOR DRAINAGE OF WALLED-OFF NECROSIS IN A RANDOMISED TRIAL" GUT, VOL. 68, NO. 7, 1 JUNE 2018, PP. 1200-1209, DOI HTTP:// DX.DOI.ORG/10.1136/GUTJNL- 2017- 315335. (B)(4). THE DEVICES HAVE NOT BEEN RECEIVED FOR ANALYSIS; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICES COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES REFERENCED IN THE LITERATURE ARTICLE. REFER TO MANUFACTURER REPORT NUMBER 12610876 FOR THE FIRST HOT AXIOS AND 12667063 FOR THE SECOND ADVANIX PANCREATIC. BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF MULTIPLE EVENTS INVOLVING ADVANIX PANCREATIC STENTS THROUGH THE ARTICLE "NON-SUPERIORITY OF LUMEN-APPOSING METAL STENTS OVER PLASTIC STENTS FOR DRAINAGE OF WALLED-OFF NECROSIS IN A RANDOMISED TRIAL" WRITTEN BY JI YOUNG BANG, ET AL. (SEE CITATION IN BLOCK H10). ACCORDING TO THE LITERATURE, THE AIM OF THE STUDY WAS TO COMPARE EFFICACY OF LUMEN-APPOSING METAL STENTS (LAMS) (HOT AXIOS) AND PLASTICS STENTS (ADVANIX PANCREATIC) FOR DRAINAGE OF WALLED-OFF NECROSIS (WON) AS LAMS ADVANTAGE OVER PLASTIC STENTS IS UNCLEAR. BETWEEN FEBRUARY 2016 AND MARCH 2017, 80 PATIENTS WERE SCREENED AND 60 PATIENTS WITH WON UNDERWENT RANDOMIZATION: 31 PATIENTS IN THE LAMS GROUP AND 29 PATIENTS IN THE PLASTIC GROUP. THE PLASTIC STENT USED WAS REPORTED TO BE A 7FR 4CM BOSTON SCIENTIFIC DOUBLE PIGTAIL STENT. THE ETIOLOGY OF PANCREATITIS FOR THE PATIENTS WHO RECEIVED A PLASTIC STENT IS AS FOLLOWS: 5% ALCOHOL, 34.5% GALLSTONES, IDIOPATHIC (41.4%), OTHER (6.9%) AND A MEDIAN DEGREE OF NECROSIS OF 50%. THE WON WAS LOCATED IN THE HEAD/UNCINATE OF THE PANCREAS IN 20.7% OF CASES AND IN THE BODY/TAIL IN 79.3% OF CASES. THE PLASTIC STENT WAS PLACED TRANSESOPHAGEAL IN 3.4% OF CASES, TRANSGASTRICALLY IN 82.8% OF CASES AND TRANSDUODENALLY IN 13.8% OF CASES. PLASTIC STENT RELATED EVENTS WERE ENCOUNTERED IN 2 OUT OF 29 PATIENTS, COMPRISING MIGRATION OF THE STENTS INTO THE JEJUNUM IN BOTH CASES. ALL MIGRATED PLASTIC STENTS WERE RETRIEVED AT ENDOSCOPY USING RAT-TOOTH FORCEPS. CLINICAL ADVERSE EVENTS WERE ENCOUNTERED IN 4 OF 29 PATIENTS THAT WERE MANAGED SUCCESSFULLY. ONE PATIENT PRESENTED WITH BLEEDING FROM THE TRANSMURAL TRACT; THIS PATIENT BLED FROM A PREVIOUSLY TREATED SPLENIC ARTERY PSEUDOANEURYSM (PRIOR TO INDEX INTERVENTION) AND REQUIRED A REPEAT COIL EMBOLISATION. RESPIRATORY EVENTS OCCURRED IN THREE PATIENTS THAT INCLUDED ASPIRATION PNEUMONIA IN TWO AND PULMONARY EMBOLISM IN ONE. PANCREATOGRAPHY REVEALED A NORMAL MAIN PANCREATIC DUCT IN 9, DPDS IN 17, PARTIAL DUCT DISRUPTION IN 2 AND DUCTAL STATUS WAS UNKNOWN IN 1 PATIENT. A TRANSPAPILLARY PANCREATIC DUCT STENT BRIDGING THE LEAK WAS PLACED IN ALL PATIENTS WITH PARTIAL DISRUPTION, RESULTING IN SUCCESSFUL RESOLUTION OF THE LEAK. THE INDWELLING PLASTIC ENDOPROSTHESES WERE LEFT IN SITU INDEFINITELY IN ALL PATIENTS WITH DPDS. THE STUDY CONCLUDED, THEY DID NOT OBSERVE ANY SIGNIFICANT DIFFERENCE IN THE PRIMARY OR SECONDARY OUTCOMES BETWEEN PATIENTS TREATED WITH LAMS OR PLASTIC STENTS EXCEPT FOR INITIAL PROCEDURE, DURATION WITH LAMS BEING SHORTER, AND THE RATE OF STENT-RELATED ADVERSE EVENTS PRIOR TO PROTOCOL CHANGE. ADDITIONALLY, THE STUDY FOUND THAT GIVEN THE FASTER RESOLUTION OF WON, TO MINIMIZE ADVERSE EVENTS, PATIENTS UNDERGOING LAMS PLACEMENT SHOULD UNDERGO FOLLOW-UP IMAGING AT 3 WEEKS WITH STENT REMOVAL IF THE FLUID COLLECTION HAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850216 NAVIFLEX RX PUSHER CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention