BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEPATIC ARTERY INFUSION PUMP

    MDR report key: 16630134 · Received March 28, 2023

    Report

    Report Number
    3015537318-2023-00012
    Event Type
    Injury
    Date Received
    March 28, 2023
    Report Date
    March 28, 2023
    Manufacturer
    INTERA ONCOLOGY
    Product Code
    LKK
    PMA / PMN Number
    P890055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE IS ASSUMED TO BE AN INTERA 3000 HEPATIC ARTERY INFUSION PUMP OR INTERA TAPERED CATHETER; HOWEVER THE DEVICE NAME WAS NOT REPORTED. THE INTERA 3000 IFU LISTS MIGRATION AND EXTRAVASATION AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE DEVICE. BLANK FIELDS IN THE MDR FORM REPRESENTS UNKNOWN INFORMATION. IF FURTHER INFORMATION IS RECEIVED AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    CASE ABSTRACT: JOHNSON, DT, BALDWIN N, AHMED AM. S2856 POKE THE BEAR AND GET THE CLAWS: LIFE-THREATENING BLEEDING BY HEPATIC ARTERY INFUSION PUMP FISTULA MANAGED BY OVER THE SCOPE CLIP CLOSURE. AM J GASTROENTEROLOGY. OCTOBER 2022. 117(10S):P E1863-E1864. INTRODUCTION: HEPATIC ARTERY INFUSION (HAI) PUMPS MAY BE USED FOR REGIONAL DELIVERY OF CHEMOTHERAPY FOR TREATMENT OF COLORECTAL CANCER LIVER METASTASES. COMPLICATIONS ARE RARE, BUT CAN INCLUDE ARTERIAL THROMBUS AND CATHETER DISLOCATION. WE PRESENT A CASE OF DUODENAL FISTULA ASSOCIATED WITH HEPATIC ARTERY INFUSION PUMP AND SUBSEQUENT CLOSURE WITH OVER THE SCOPE CLIP. CASE DESCRIPTION/METHODS: WE PRESENT THE CASE OF A 57-YEAR-OLD MALE WITH STAGE IV COLON ADENOCARCINOMA AND LIVER METASTASIS WHO UNDERWENT PLACEMENT OF HEPATIC ARTERY INFUSION (HAI) PUMP FOR LOCAL CHEMOTHERAPY. 6 MONTHS LATER, HE PRESENTED WITH 3 DAYS OF MELENA AND FATIGUE WITH VITALS DEMONSTRATING HEART RATE 129 BPM AND BLOOD PRESSURE WAS 111/69 MMHG. NOTABLY, HEMOGLOBIN WAS 9.1 G/DL, DOWN FROM A BASELINE OF 14.4 G/DL. HE WAS ADMITTED TO THE SURGICAL ONCOLOGY SERVICE AND GASTROENTEROLOGY WAS CONSULTED FOR SUSPECTED UPPER GI BLEED. ESOPHAGOGASTRODUODENOSCOPY (EGD) PERFORMED THE DAY AFTER ADMISSION REVEALED SUSPECTED FISTULA IN THE DUODENAL BULB. BLEEDING RESOLVED WITH PROTON PUMP INHIBITOR THERAPY ALONE WITH PLAN FOR OUTPATIENT REPEAT ENDOSCOPY. 1 MONTH LATER THE PATIENT PRESENTED WITH ANEMIA, MELENA AND ACUTE BLOOD LOSS. REPEAT EGD DEMONSTRATED A BLEEDING DUODENAL BULB LESION AND HEMOSTASIS WAS ACHIEVED BY PLACEMENT OF A 12/6T OVER THE SCOPE CLIP PLACEMENT. SUBSEQUENT CTA SCAN IDENTIFIED THE HEPATIC ARTERY INFUSION PUMP TIP ADJACENT TO OVER THE SCOPE CLIP IN THE PROXIMAL DUODENUM WITH NO EXTRAVASATION SUGGESTING RESOLUTION OF BLEEDING AFTER CLIP PLACEMENT. (FIGURE). DISCUSSION: WE PRESENT A RARE CASE OF DUODENAL BLEEDING DUE TO HEPATIC ARTERY INFUSION CATHETER TIP DISLOCATION. A LARGE SINGLE CENTER EXPERIENCE OF 544 PATIENTS OVER A 15-YEAR PERIOD DEMONSTRATED THE MOST COMMON COMPLICATIONS FROM HAI TO INCLUDE ARTERIAL THROMBOSIS (6%), CATHETER OCCLUSION/DISLODGEMENT (6%) AND EXTRAHEPATIC PERFUSION (3%)1. FURTHERMORE, LITERATURE SEARCH FOR CASES FROM 1975-2022 REVEALS FEWER THAN 10 CASES WITH THIS BLEEDING COMPLICATION. IN THIS CASE WE DEMONSTRATE THE SUCCESSFUL USE OF AN OTSC TO MANAGE BLEEDING ASSOCIATED FROM THE FISTULA CREATED BY THE INFUSION PUMP CATHETER BETWEEN HEPATIC ARTERY AND DUODENAL BULB.POKE THE BEAR AND GET THE CLAWS: LIFE-THREATENING BLEEDING BY HEPATIC ARTERY INFUSION PUMP FISTULA MANAGED BY OVER THE SCOPE CLIP CLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555431 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Life Threatening| R