BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 17821451 · Received September 26, 2023

    Report

    Report Number
    3010757606-2023-00663
    Event Type
    Injury
    Date Received
    September 26, 2023
    Report Date
    September 25, 2023
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE NUMBER (B)(4). CATALOG NUMBER IN D4 IS THE INTERNATIONAL LIST NUMBER WHICH IS SIMILAR TO US LIST NUMBER OF 062918. THE DEVICE MANUFACTURER AND LOT NUMBER OF THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT PROVIDED. THEREFORE, IT IS UNKNOWN IF THE DEVICE INVOLVED WAS ABBVIE BRANDED TUBING. CONSERVATIVELY, ABBVIE HAS CHOSEN TO REPORT THIS COMPLAINT DUE TO THE POTENTIAL THAT THE DEVICE INVOLVED COULD HAVE BEEN ABBVIE BRANDED TUBING. THE DEVICE INVOLVED IN THE EVENT WAS NOT RETURNED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. BOWEL OBSTRUCTION, FISTULA, AND INTUSSUSCEPTION ARE KNOWN ARE KNOWN COMPLICATIONS OF A PEG- J TUBE PLACEMENT. HEALTH EFFECT CLINICAL CODE OF 4581 WAS CHOSEN TO CAPTURE THE EVENT OF A INTUSSUSCEPTION. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    LITERATURE ARTICLE RECEIVED FROM INDIA: ON AN UNKNOWN DATE, A 86 YEAR OLD FEMALE UNDERWENT A REVISION DUE TO AN UNSPECIFIED OBSTRUCTION. THE PATIENT BEGAN TO HAVE INTERMITTENT CRAMPING, ABDOMINAL PAIN, AND LEAKAGE FROM THE GJ TUBE SITE. AT THAT TIME, PATIENT UNDERWENT A CT SCAN OF THE ABDOMEN AND PELVIS WHICH REVEALED NO OBSTRUCTION OR SIGNIFICANT ABNORMALITIES. SYMPTOMS HAD IMPROVED SOMEWHAT. ON AN UNKNOWN DATE 6 TO 8 MONTHS LATER, THE PATIENT FELT THE SYMPTOMS HAD RETURNED AND NOTED THAT THE GJ TUBE WAS LEAKING AND THE STOMA WAS IRRITATED. ABDOMINAL PAIN AT THE TIME WAS SIGNIFICANT ENOUGH TO REQUIRE NARCOTICS AND EPIDURAL PAIN TREATMENT. A REPEAT CT WAS DONE WHICH SHOWED A CLOVERLEAF FIGURATION SHOWING THE GJ TUBE BYPASSING THE DUODENUM AND LEADING INTO THE JEJUNUM, RAISING CONCERN FOR ONGOING SEALED PERFORATION OR FISTULIZATION AND A GJ TUBE WITH AN INTRALUMINAL ANCHOR APPLIED TO THE GASTRIC WALL. ADDITIONALLY, A SMALL BOWEL OBSTRUCTION INVOLVING THE LONG-SEGMENT JEJUNAL¿JEJUNAL INTUSSUSCEPTION WAS ASSOCIATED WITH THE JEJUNOSTOMY LIMB OF THE GJ TUBE. THE CT ALSO SHOWED SUPERIOR MESENTERIC VENOUS OCCLUSION (SMV), WHICH WAS NOT PRESENT IN PREVIOUS IMAGING. THROUGHOUT THIS TIME, THE PATIENT HAS HAD PARKINSON'S MEDICATIONS ACTIVELY MANAGED AND CHRONIC CONSTIPATION AND ELECTROCARDIOGRAM ABNORMALITIES MANAGED BY A RESPECTIVE SPECIALIST TEAM. ON PRESENTATION TO THE EMERGENCY ROOM (ER), PATIENT FELT FINE AND NO ABDOMINAL PAIN. PATIENT HAD A NORMAL APPETITE, BUT HAS NOT EATEN RECENTLY. BOWEL HABITS HAVE NOT CHANGED FROM ROUGHLY ONCE EVERY OTHER DAY OF SOFT AND NOT FULLY FORMED STOOL. PATIENT DENIED NAUSEA, VOMITING, HEADACHE, CHEST PAIN, AND SHORTNESS OF BREATH OR ANY URINARY CHANGES IN FREQUENCY, COLOR, OR SMELL. IN ADDITION, LABORATORY TESTS WERE NORMAL. IMAGING FOR CHRONIC ABDOMINAL PAIN SINCE THE EXCHANGE OF THE GJ TUBE DEMONSTRATED A LIKELY GASTRO-ENTERIC FISTULA, JEJUNAL¿JEJUNAL LONG-SEGMENT INTUSSUSCEPTION, AND SMV OCCLUSION WITH DISTAL RECONSTITUTION. SURGERY WAS CONSULTED BY GASTROENTEROLOGY FOR ASSISTANCE WITH THE MANAGEMENT OF JEJUNAL¿JEJUNAL INTUSSUSCEPTION, LIKELY CAUSED BY THE JEJUNAL PORTION OF THE GJ TUBE ACTING AS A LEAD POINT. NO ACUTE SURGICAL INTERVENTION WAS REQUIRED FOR INTUSSUSCEPTION AS THE PATIENT WAS WITHOUT SIGNS OF BOWEL ISCHEMIA ON IMAGING OR LABORATORIES, HAD NORMAL VITAL SIGNS, HAD CHRONIC ABDOMINAL SYMPTOMS WITHOUT ANY NEW COMPLAINTS, AND WAS NOT PERITONITIC ON EXAMINATION BECAUSE OF THE ABSENCE OF WORSENING ABDOMINAL PAIN OR TENDERNESS, NEW-ONSET NAUSEA AND EMESIS/OBSTRUCTIVE SYMPTOMS, TACHYCARDIA, AND HYPOTENSION. THE PLAN WAS MADE TO REMOVE THE JEJUNOSTOMY PORTION OF THE GJ TUBE ENDOSCOPICALLY, AND THE PATIENT WAS NIL PER ORAL (NPO). THE PATIENT RESPONDED WELL TO THE TREATMENT GIVEN AND WAS DISCHARGED FOR FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018929 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Required Intervention| O PEG TUBE, UNKNOWN MANUFACTURER