BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOUBLE PIGTAIL BILIARY STENT

    MDR report key: 12452200 · Received September 10, 2021

    Report

    Report Number
    3001845648-2021-00660
    Event Type
    Malfunction
    Date Received
    September 10, 2021
    Date of Event
    October 6, 2018
    Report Date
    October 6, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K851962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DOUBLE PIGTAIL STENT OF UNKNOWN LOT NUMBER AND RPN INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE. COMPARISON OF CLINICAL OUTCOMES BETWEEN PLASTIC STENT AND NOVEL LUMEN-APPOSING METAL STENT FOR ENDOSCOPIC ULTRASOUND-GUIDED DRAINAGE OF PERIPANCREATIC FLUID COLLECTIONS (SHIN ET AL 2018). THIS COMPLAINT COVERS OFF LABEL USE BY PLACEMENT OF STENTS THROUGH EUS, USED TRANSMURALLY FOR THE DRAINAGE OF PERIPANCREATIC FLUID COLLECTION AND OFF LABEL PLACEMENT OF DOUBLE PIGTAIL IN PFC'S, USED TRANSMURALLY FOR THE DRAINAGE OF PERIPANCREATIC FLUID COLLECTIONS. DOCUMENT REVIEW: AS THE RPN AND LOT NUMBER OF THE COMPLAINT DEVICES ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL COTTON-LEUNG BILIARY STENT DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. THE INSTRUCTIONS FOR USE WHICH WOULD ACCOMPANY THIS DEVICE (IFU0055-4 ) INSTRUCTS THE USER TO ¿VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE.¿ IT SHOULD BE NOTED THAT THE DEVICE WAS USED OFF-LABEL, OUTSIDE ITS INTENDED USE STATED IN THE INSTRUCTIONS FOR USE (IFU0055-4 ) "THIS DEVICE IS USED TO DRAIN OBSTRUCTED PANCREATIC DUCTS" AND IN THE NOTES SECTION ¿DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED INTENDED USE.¿ 27 PATIENTS WERE INVOLVED IN THIS STUDY AND ACCORDING TO THE INFORMATION RECEIVED DOUBLE PIGTAIL STENTS WERE USED FOR ALL THE PATIENTS. STENTS WERE PLACED THROUGH EUS FOR DRAINAGE OF PERIPANCREATIC FLUID COLLECTION, THIS IS REGARDED AS OFF LABEL USE AS THE DEVICE WAS USED TRANSMURALLY. ACCORDING TO OUR CLINICAL ADVISER THE PNEUMOPERITONEUM AND INTRAPROCEDURAL HEMORRHAGE WERE NOT RELATED TO THE COOK DEVICE. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THE OFF-LABEL USE OF THE DEVICE, WHEN THE DEVICE IS OUTSIDE ITS STATED INTENDED USE IT MAY LEAD TO OUTCOMES THAT WERE NEVER INTENDED TO HAPPEN AND WERE NEVER STUDIED. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INFORMATION REPORTED, FOLLOW UP SURGERY AND EUS DRAINAGE WAS REQUIRED AND SPONTANEOUS REGRESSION OCCURRED. ACCORDING TO THE INFORMATION RECEIVED THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    SHIN ET AL, 2018, UNKNOWN DOUBLE PIGTAIL PLASTIC STENT, COMPARISON OF CLINICAL OUTCOMES BETWEEN PLASTIC STENT AND NOVEL LUMEN-APPOSING METAL STENT FOR ENDOSCOPIC ULTRASOUND-GUIDED DRAINAGE OF PERIPANCREATIC FLUID COLLECTIONS A TOTAL OF 27 PATIENTS (MEDIAN AGE, 56 YEARS) WITH PFCS UNDERWENT EUS-GUIDED TRANSMURAL DRAINAGE BETWEEN JANUARY 2011 AND DECEMBER 2017. OF THESE, 17 UNDERWENT PS PLACEMENT AND 10 UNDERWENT LAMS PLACEMENT. ALL ENDOSCOPIC PROCEDURES WERE PERFORMED UNDER CONSCIOUS SEDATION USING MEPERIDINE, PROPOFOL, AND/OR MIDAZOLAM AFTER OBTAINING WRITTEN INFORMED CONSENT FOR THE PROCEDURE. EUS PROCEDURES WERE PERFORMED BY 2 EXPERIENCED ENDOSCOPISTS (MKJ AND CMC), WHO HAD PERFORMED OVER 200 PROCEDURES OF EUS-GUIDED TISSUE SAMPLING, WITH A LINEAR ECHOENDOSCOPE (GF-UCT240; OLYMPUS MEDICAL SYSTEMS, TOKYO, JAPAN) AND FLUOROSCOPY. AFTER AVOIDING INTERVENING BLOOD VESSELS WITH COLOR DOPPLER AND ENSURING A SHORT DISTANCE BETWEEN THE WALL OF THE COLLECTION AND BOWEL WALL, PUNCTURE FOR PFCS WAS ACCOMPLISHED USING A 19 G NEEDLE (BOSTON SCIENTIFIC CO., NATICK, MA, USA), FOLLOWED BY ADVANCEMENT OF A LONG 0.035-INCH GUIDEWIRE INTO THE FLUID COLLECTION AND COILING UNDER FLUOROSCOPIC GUIDANCE. AFTER REMOVING THE NEEDLE, THE TRACT WAS THEN DILATED WITH A NEEDLE KNIFE CATHETER, BALLOON DILATOR, OR CYSTOTOME AT THE DISCRETION OF THE ENDOSCOPIST. THE PARTICIPATING ENDOSCOPIST DETERMINED THE TYPE, SIZE, AND NUMBER OF STENTS. BEFORE THE INTRODUCTION OF LAMS (SPAXUS; TAEWOONG MEDICAL, SEOUL, KOREA) IN OCTOBER 2016 (FIG. 1), DOUBLE-PIGTAIL PSS (7 OR 10 FR; COOK MEDICAL, WINSTON-SALEM, NC, USA) WERE USED FOR TRANSMURAL DRAINAGE. AES INCLUDED PNEUMOPERITONEUM IN 3 PATIENTS, INTRAPROCEDURAL BLEEDING IN 2, AND ABDOMINAL PAIN IN 1. PATIENTS WITH PNEUMOPERITONEUM HAD NO SYMPTOMS AND SPONTANEOUS RESOLUTION WITHOUT SPECIFIC MANAGEMENT. INTRAPROCEDURAL HEMORRHAGE WAS OBSERVED IN 2 PATIENTS IN THE PS GROUP DURING TRACT DILATION USING A NEEDLE KNIFE CATHETER AND WAS SELF-LIMITED AFTER STENT PLACEMENT. THERE WAS NO PROCEDURE-RELATED MORTALITY. PER CLINICAL INPUT THESE AES WERE NOT RELATED TO THE COOK DEVICE. AS PER TABLE 2 OF THE LITERATURE PAPER THE AVERAGE LENGTH OF STENT STAY WAS 232.7±412.9. AS PER THE IFU THESE STENTS SHOULD NOT EXCEED INDWELLING TIME OF 3 MONTHS. THIS FILE IS CAPTURING THE OFF LABEL USE OF THE DOUBLE PIGTAIL BILIARY STENTS IN PFCS AND USER ERROR FOR EXCEEDING THE INDWELLING TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1349497 DOUBLE PIGTAIL BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR