BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND DELIVERY SYSTEM

    MDR report key: 5983093 · Received September 28, 2016

    Report

    Report Number
    3005099803-2016-02990
    Event Type
    Injury
    Date Received
    September 28, 2016
    Report Date
    September 1, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    PCU
    PMA / PMN Number
    K140561
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIFIC UPN AND LOT WERE NOT REPORTED; THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. THE CORRESPONDING AUTHOR FOR THIS ARTICLE IS LISTED AS MICHAEL KAHALEH, MD, FASGE, AT WEILL CORNELL MEDICAL COLLEGE, NEW YORK, NEW YORK, USA, AS PROVIDED IN BLOCK E1. THE FOLLOWING INSTITUTIONS ALSO TOOK PART IN THIS STUDY: GASTROENTEROLOGY DEPARTMENT, HOSPITAL UNIVERSITARIO RIO HORTEGA, VALLADOLID, SPAIN PAUL MAY AND FRANK STEIN INTERVENTIONAL ENDOSCOPY CENTER, CALIFORNIA, PACIFIC MEDICAL CENTER, SAN FRANCISCO, CALIFORNIA, USA DIVISION OF GASTROENTEROLOGY AND HEPATOLOGY, UNC SCHOOL OF MEDICINE, CHAPEL HILL, NORTH CAROLINA, USA. LITERATURE JOURNAL ARTICLE: TYBERG, AMY, ET AL.. "ENDOSCOPIC ULTRASOUND-GUIDED GASTROJEJUNOSTOMY WITH A LUMEN-APPOSING METAL STENT: A MULTICENTER, INTERNATIONAL EXPERIENCE." ENDOSCOPY INTERNATIONAL OPEN 2016; 04: E276¿E281. DOI HTTP://DX.DOI.ORG/10.1055/S-0042-101789. THE DEVICES HAVE NOT BEEN RECEIVED FOR ANALYSIS; THEREFORE 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

    BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF MULTIPLE EVENTS THROUGH THE ARTICLE "ENDOSCOPIC ULTRASOUND-GUIDED GASTROJEJUNOSTOMY WITH A LUMEN-APPOSING METAL STENT: A MULTICENTER, INTERNATIONAL EXPERIENCE" WRITTEN BY AMY TYBERG, ET AL. THE ADVERSE EVENTS REPORTED IN THE ARTICLE ARE CAPTURED IN MANUFACTURER REPORT # 3005099803-2016-02990 AND MANUFACTURER REPORT # 3005099803-2016-02991. THE ONE EVENT OF DEATH IS CAPTURED IN MANUFACTURER REPORT # 3005099803-2016-02989. ACCORDING TO THE LITERATURE, HOT AND COLD AXIOS STENTS AND DELIVERY SYSTEMS WERE USED TO TREAT GASTRIC OUTLET OBSTRUCTION (GOO) DURING ENDOSCOPIC ULTRASOUND GASTROJEJUNOSTOMY (EUS-GJ) PROCEDURES PERFORMED BETWEEN MARCH 2014 AND SEPTEMBER 2015. A TOTAL OF 29 PATIENTS WERE INCLUDED IN THE STUDY, OF WHOM 11 WERE MALE (42%) AND WHOSE MEAN AGE WAS 66.2 YEARS (RANGE 34-90). THE INDICATIONS FOR EUS-GJ INCLUDED 17 CASES OF MALIGNANT GOO AND 9 CASES OF BENIGN GOO. A HOT AXIOS STENT AND DELIVERY SYSTEM WAS USED IN 9 PATIENTS (35%), AND A COLD AXIOS STENT AND DELIVERY SYSTEM WAS USED IN THE REMAINING PATIENTS. IN 25 PATIENTS (96 %), A 15-MM DIAMETER AXIOS STENT WAS USED, AND IN 1 PATIENT, A 10-MM-DIAMETER AXIOS STENT WAS PLACED. DURING STENT PLACEMENT, IF THE CAUTERY-TIPPED LAMS DELIVERY SYSTEM WAS NOT AVAILABLE, THE FISTULOUS TRACT WAS SERIALLY DILATED WITH A NEEDLE-KNIFE AND A BALLOON. CONVERSELY, IF THE CAUTERY-TIPPED LAMS WAS AVAILABLE, THE DELIVERY SYSTEM WAS INSERTED IN ONE STEP WITHOUT PRIOR DILATION, EITHER OVER THE WIRE OR FREEHAND. TECHNICAL SUCCESS WAS DEFINED AS THE SUCCESSFUL PLACEMENT OF A GASTROJEJUNAL AXIOS STENT. CLINICAL SUCCESS WAS DEFINED AS THE ABILITY OF THE PATIENT TO TOLERATE AN ORAL DIET FOLLOWING THE PROCEDURE. TECHNICAL SUCCESS WAS ACHIEVED IN 24 PATIENTS (92%), AND CLINICAL SUCCESS WAS ACHIEVED IN 22 PATIENTS (85%). THE ARTICLE REPORTED THAT 1 PATIENT DEVELOPED PERITONITIS AND DIED BEFORE THE INITIATION OF AN ORAL DIET (CAPTURED IN MANUFACTURER REPORT # 3005099803-2016-02989), 7 PATIENTS HAD STENT MISPLACEMENT, 2 HAD PERSISTENT NAUSEA AND VOMITING DESPITE A PATENT EUS-GJ AND REQUIRED ENTERAL FEEDING FOR NUTRITION, 1 SUFFERED POST-PROCEDURE ABDOMINAL PAIN AND UNDERWENT SURGERY FOR SUSPECTED PERFORATION, AND 1 EXPERIENCED POST-PROCEDURAL BLEEDING REQUIRING TRANSFUSION (CAPTURED IN MANUFACTURER REPORT # 3005099803-2016-02990 AND MANUFACTURER REPORT # 3005099803-2016-02991.) OF THE 7 PATIENTS WITH STENT MISPLACEMENT, 3 HAD MISPLACEMENT OF THE PROXIMAL FLANGE AND 4 HAD MISPLACEMENT OF THE DISTAL FLANGE. IN ALL 3 PATIENTS WITH MISPLACEMENT OF THE PROXIMAL FLANGE BEYOND THE GASTRIC WALL, THE TRACT WAS SUCCESSFULLY BRIDGED WITH A TELESCOPING FULLY-COVERED SELF-EXPANDING METAL STENT. IN 2 OF THE 4 PATIENTS WITH DISTAL FLANGE MISPLACEMENT THE TRACT WAS SALVAGED WITH NATURAL ORIFICE TRANSLUMINAL ENDOSCOPIC SURGERY (NOTES) PLACEMENT OF A BRIDGING AXIOS STENT. OF THE OTHER 2 DISTAL FLANGE MISPLACEMENTS, THE FIRST IS CAPTURED BY MANUFACTURER REPORT # 3005099803-2016-02989. THE LAST CASE OF DISTAL FLANGE MISPLACEMENT INVOLVED A PATIENT WHO LATER SUFFERED POST-PROCEDURAL BLEEDING. THE DISTAL FLANGE OF THE AXIOS STENT WAS MISPLACED AND THE STENT WAS PULLED BACK INTO THE PATIENT'S STOMACH. AN ENTERAL SELF-EXPANDING METAL STENT WAS THEN PLACED THROUGH THE LUMINAL STRICTURE WITHOUT FISTULA CLOSURE. POST-PROCEDURAL BLEEDING REQUIRING TRANSFUSION DEVELOPED, THOUGH THERE WAS NO PERITONITIS OR PERFORATION. THIS PATIENT DIED OF DISEASE PROGRESSION 4 MONTHS AFTER STENT IMPLANTATION. THE ONE PATIENT WHO SUFFERED POST-PROCEDURAL ABDOMINAL PAIN WAS TAKEN TO SURGERY BEFORE CONSULTATION WITH THE ENDOSCOPIST DUE TO THE APPEARANCE OF FREE AIR ON IMAGING. SURGICAL EVALUATION REVEALED A CORRECTLY DEPLOYED AXIOS STENT WITH A BRIDGING FULLY-COVERED SELF-EXPANDING METAL STENT, BUT SURGICAL GASTROJEJUNOSTOMY WAS PERFORMED AT THE DISCRETION OF THE SURGEON. BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THESE EVENTS TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. NOTE: THE AXIOS STENT WAS IMPLANTED TRANSGASTRIC TO THE JEJUNUM TO TREAT GASTRIC OUTLET OBSTRUCTION; HOWEVER THE AXIOS STENT AND DELIVERY SYSTEM IS NOT INDICATED FOR GASTROJEJUNOSTOMY (EUS-GJ) PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635616 AXIOS STENT AND DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC - MARLBOROUGH UNK894

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention