BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 2614614 · Received June 13, 2012

    Report

    Report Number
    3007566237-2012-01337
    Event Type
    Injury
    Date Received
    June 13, 2012
    Date of Event
    October 12, 2011
    Report Date
    May 16, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P990034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATES WERE NOT PROVIDED. DATE IS BASED ON THE DATE THE ARTICLE WAS RECEIVED FOR PUBLICATION. IT WAS NOT POSSIBLE TO MATCH THESE EVENTS WITH PREVIOUSLY REPORTED EVENTS. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PATIENT. (B)(4). BILOMA.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    ITO, K., ITO, H., KEMENY, N., GONENN M., ALLEN, P. J., PATY, P. B., FONG, Y., DEMATTEO, R. P., BLUMGART, L. H., JARNAGIN, W. R., D ANGELICA, M. I. BILIARY SCLEROSIS AFTER HEPATIC ARTERIAL INFUSION PUMP CHEMOTHERAPY FOR PATIENTS WITH COLORECTAL CANCER LIVER METASTASIS: INCIDENCE, CLINICAL FEATURES, AND RISK FACTORS. ANNALS OF SURGICAL ONCOLOGY. 2012;19(5):1609-1617. HEPATIC ARTERIAL INFUSION PUMP CHEMOTHERAPY (HAIPC) CONTRIBUTES TO THE PROLONGED SURVIVAL OF SELECTED PATIENTS WITH COLORECTAL CANCER LIVER METASTASES (CRCLM). THE MOST CLINICALLY IMPORTANT ADVERSE EVENT AFTER HAIPC WITH FLOXURIDINE (FUDR) IS BILIARY SCLEROSIS (BS). LITTLE IS KNOWN ABOUT THE ETIOLOGY OF BS. HAIPC WAS ADMINISTERED TO 475 CONSECUTIVE PATIENTS WHO RECEIVED HAIPC ON PROSPECTIVE PROTOCOLS FROM 1991 TO 2008. THE INCIDENCE, CLINICAL FEATURES, VARI- ABLES RELATED TO DEMOGRAPHICS, COMORBIDITY, MEDICAL HISTORY, CRCLM, SURGERY, CHEMOTHERAPY, AND LABORATORY DATA WERE REVIEWED. AN ANALYSIS OF FACTORS POTENTIALLY ASSOCIATED WITH BS, DEFINED AS A BILIARY STRICTURE RELATED TO HAIPC REQUIRING STENT PLACEMENT, WAS PERFORMED. THE INCIDENCE OF BS WAS 5.5% (16 OF 293) IN PATIENTS RECEIVING HAIPC AS AN ADJUVANT THERAPY AFTER HEPATECTOMY, AND 2% (2 OF 100) IN PATIENTS RECEIVING HAIPC WITH FUDR FOR UNRESECTABLE DISEASE. THE COMMON HEPATIC DUCT WAS THE SITE MOST FREQUENTLY AFFECTED (87.5%). IN PATIENTS RECEIVING ADJUVANT HAIPC, BS WAS ASSOCIATED WITH ABNORMAL POSTOPERATIVE FLOW SCANS (18.8% VS. 1.8%, P = 0.006), POSTOPERATIVE INFECTIOUS COMPLICATIONS (50.0% VS. 14.8%, P = 0.002), AND LARGER DOSE/CYCLE/WEIGHT OF FUDR (2.6 VS. 2.0 MG/CYCLE/KG, P = 0.025) THAN PATIENTS WITHOUT BS. NO PATIENT DIED DIRECTLY OF BS. MEDIAN SURVIVAL WAS NOT COMPROMISED BY THE DEVELOPMENT OF BS (BS VS. NON-BS: 61.0 MONTHS [RANGE 6.2-171.6 MONTHS] VS. 47.2 MONTHS [RANGE 2.4-200.8 MONTHS], P = 0.316, RESPECTIVELY). CONCLUSIONS. BS IS AN UNCOMMON COMPLICATION AFTER HAIPC AND DOES NOT COMPROMISE SURVIVAL IF ADEQUATELY SALVAGED BY STENTING OR DILATATION. SURGICAL COMPLICATIONS AS WELL AS TYPE AND DOSE OF INTRA-ARTERIAL CHEMOTHERAPY MAY CONTRIBUTE TO THE DEVELOPMENT OF BS. REPORTED EVENTS: 16 PATIENTS WITH FUDR ALONE PROTOCOL AND HEPATECTOMY DEVELOPED BILIARY SCLEROSIS REQUIRING STENT PLACEMENT. ONE PATIENT IN THE UNRESECTABLE GROUP WITH FUDR ALONE PROTOCOL DEVELOPED BILIARY SCLEROSIS REQUIRING STENT PLACEMENT. THE PATIENT HAD BILOBAR DISEASE AND VARIANT HEPATIC ARTERIAL ANATOMY. AN ACCESSORY LEFT HEPATIC ARTERY WAS LIGATED. ONE PATIENT IN THE UNRESECTABLE GROUP WITH FUDR ALONE PROTOCOL DEVELOPED BILIARY SCLEROSIS. THE PATIENT HAD BILOBAR DISEASE AND VARIANT HEPATIC ARTERIAL ANATOMY. THERE WAS A TRIFURCATION OF THE COMMON HEPATIC ARTERY INTO THE GDA WHICH REQUIRED LIGATION OF THE LEFT HEPATIC ARTERY. ELEVEN PATIENTS WITH FUDR AND MITOMYCIN PROTOCOL DEVELOPED BILIARY SCLEROSIS REQUIRING STENT PLACEMENT. ALL PATIENTS WERE MANAGED SUCCESSFULLY WITH BILIARY STENTING AND/OR DILATION. THERE WAS NO MORTALITY DUE TO BILIARY SCLEROSIS. THREE PATIENTS WITH BILIARY SCLEROSIS DEVELOPED WOUND INFECTION. ONE PATIENT WITH BILIARY SCLEROSIS DEVELOPED A PUMP POCKET INFECTION. ONE PATIENT WITH BILIARY SCLEROSIS DEVELOPED A CATHETER INFECTION. ONE PATIENT WITH BILIARY SCLEROSIS DEVELOPED AN INFECTED BILOMA. ONE PATIENT WITH BILIARY SCLEROSIS DEVELOPED A URINARY TRACT INFECTION. ADDITIONAL INFORMATION IS BEING REQUESTED AT THIS TIME; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    REPORTED EVENT: 62 PATIENTS DEVELOPED HYPERBILIRUBINEMIA DUE TO HAIPC. IN THESE PATIENTS, FUDR WAS HELD AND STEROIDS CONTINUED THROUGH THE PUMP. HYPERBILIRUBINEMIA RESOLVED WITH THESE TREATMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHETER MODEL UNK, LOT # UNK