BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 4164724 · Received October 10, 2014

    Report

    Report Number
    3007566237-2014-02928
    Event Type
    Injury
    Date Received
    October 10, 2014
    Report Date
    September 12, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED SEX REFLECTS THAT OF THE MAJORITY OF THE PATIENTS REPORTED IN THE LITERATURE ARTICLE. IT WAS NOT POSSIBLE TO MATCH THESE EVENTS WITH ANY PREVIOUSLY REPORTED EVENTS. CONCOMITANT PRODUCT: PRODUCT ID NEU_UNKNOWN_CATH, LOT # UNKNOWN, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    PEREZ, D.R., KEMENY, N.E., BROWN, K.T., GEWIRTZ, A.N., PATY, P.B., JARNAGIN, W.R., D'ANGELICA, M.I. ANGIOGRAPHIC IDENTIFICATION OF EXTRAHEPATIC PERFUSION AFTER HEPATIC ARTERIAL PUMP PLACEMENT: IMPLICATIONS FOR SURGICAL PREVENTION. HPB. 2014; 16(8):744-748. SUMMARY: HEPATIC ARTERIAL INFUSION (HAI) CHEMOTHERAPY IS AN EFFECTIVE TREATMENT FOR PATIENTS WITH LIVER MALIGNANCY. EXTRAHEPATIC PERFUSION (EHP) AFTER HAI PUMP PLACEMENT REQUIRES CORRECTION PRIOR TO STARTING CHEMOTHERAPY. THE AIM OF THIS STUDY WAS TO DEFINE THE ORIGIN OF ARTERIAL BRANCHES CAUSING EHP IN ORDER TO DETERMINE IF ALTERATIONS IN SURGICAL TECHNIQUE DURING PUMP PLACEMENT MIGHT PREVENT EHP. A PROSPECTIVELY MAINTAINED, SINGLE-CENTRE HAI DATABASE WAS REVIEWED FOR ALL PATIENTS (2008¿2011) WITH EHP. THE ORIGIN OF ARTERIAL BRANCHES CAUSING EHP WAS CLASSIFIED ANATOMICALLY AND PATIENT OUTCOMES WERE ANALYSED. REPORTED EVENTS: HAI PUMPS WERE PLACED IN 327 PATIENTS DURING THE 3-YEAR STUDY PERIOD. POST-OPERATIVELY AND BEFORE USING THE PUMP, 24 (7.3%) PATIENTS HAD EVIDENCE OF EHP ON NUCLEAR LIVER SCINTIGRAPHY. TWENTY-ONE OF THE 24 PATIENTS HAD STANDARD CELIAC AND HEPATIC VASCULAR ANATOMY. THE PATIENTS WITH ACCESSORY HEPATIC ARTERY BRANCHES HAD THOSE LIGATED AT THE TIME OF OPERATION. ONE PATIENT HAD AN ACCESSORY RHA ORIGINATING FROM THE GDA BEYOND THE TAKE OFF OF THE LHA; IN THIS PATIENT, THE LHA WAS LIGATED AND THE HAI CATHETER WAS PLACED IN THE GDA UP TO THE ORIGIN OF THE RHA. THE HAI CATHETER WAS INSERTED INTO THE GDA IN ALL BUT ONE OF THE PATIENTS. IN ONE PATIENT, THE HAI CATHETER WAS PLACED INTO A LARGE RIGHT GASTRIC ARTERY, WHICH WAS JUDGED TO BETTER ACCOMMODATE THE CATHETER THAN THE GDA. THE GDA AND RIGHT GASTRIC ARTERY WERE LIGATED IN THIS PATIENT. THE DUODENUM (N = 19), PANCREAS (N = 12) AND STOMACH (N = 7) WERE THE SITES OF EHP. THREE OUT OF 24 PATIENTS HAD SIMULTANEOUS PERFUSION OF ALL THREE AREAS. NINE OUT OF 24 PATIENTS HAD SIMULTANEOUS PERFUSION OF TWO AREAS, WHICH INCLUDED EITHER THE PANCREAS AND STOMACH (N = 5) OR THE DUODENUM AND STOMACH (N = 4). THE BRANCH RESPONSIBLE FOR EHP AROSE FROM THE PHA, 1ST, 2ND, AND 3RD ORDER HEPATIC ARTERY BRANCHES IN 7, 10, 5 AND 2 OF THE 24 PATIENTS, RESPECTIVELY. IT IS NOTEWORTHY THAT IN 17 OF THESE PATIENTS THE VESSEL RESPONSIBLE FOR EHP WAS RELATIVELY PROXIMAL AND ORIGINATED FROM THE PHA OR 1ST ORDER BRANCHES (LHA OR RHA). OF THE 17 VESSELS DISTAL TO THE PHA RESPONSIBLE FOR EHP, 13 AROSE FROM THE RHA. THE DISTANCE BETWEEN THE TIP OF THE HAI CATHETER AND THE ORIGIN OF THE ABERRANT VESSEL WAS ESTIMATED TO BE >2 CM IN 15 PATIENTS AND =2 CM IN 9 PATIENTS. IN RETROSPECT, AFTER SPECIFIC REVIEW, 3 OUT OF 24 PATIENTS HAD AN ABERRANT ARTERIAL BRANCH THAT WAS APPARENT ON PREOPERATIVE CTA. OF THE 24 PATIENTS WITH EHP: EIGHTEEN PATIENTS UNDERWENT SUCCESSFUL EMBOLIZATION OF THE ABERRANT ARTERIAL BRANCH AND THE HAI PUMPS WERE SUCCESSFULLY USED FOR CHEMOTHERAPY. TWO WERE SUCCESSFULLY TREATED WITH SURGICAL LIGATION OF ABERRANT ARTERIAL BRANCHES AFTER A FAILURE OF EMBOLIZATION. IN ONE PATIENT, THERE WAS A PERMANENT INABILITY TO ADMINISTER PUMP CHEMOTHERAPY BECAUSE THE BRANCH RESPONSIBLE FOR EHP COULD NOT BE EMBOLIZED. IN ONE PATIENT, THERE WAS A PERMANENT INABILITY TO ADMINISTER PUMP CHEMOTHERAPY BECAUSE THERE WAS A CELIAC STENOSIS THAT WAS RESPONSIBLE FOR EHP THOUGHT TO BE SECONDARY TO THE MEDIAN ARCUATE LIGAMENT. THE COLLATERAL FLOW FROM THE SUPERIOR MESENTERIC ARTERY TO THE CELIAC TERRITORY RESULTED IN REVERSAL OF FLOW IN THE COMMON HEPATIC ARTERY (CHA) WITH PERFUSION FROM THE PUMP CATHETER OF THE STOMACH, PANCREAS AND SPLEEN. THERE HAD BEEN A FAILURE TO EMBOLIZE AND THE CAUSE OF THE EHP COULD NOT BE REMEDIED. IN ONE PATIENT, THERE WAS A PERMANENT INABILITY TO ADMINISTER PUMP CHEMOTHERAPY BECAUSE THE PATIENT DEVELOPED PERFORATION OF THE PUMP CATHETER INTO THE DUODENUM WITH ACTIVE BLEEDING FOUND DURING ANGIOGRAPHY. THERE HAD BEEN A FAILURE TO EMBOLIZE. IN ONE PATIENT, THERE WAS A PERMANENT INABILITY TO ADMINISTER PUMP CHEMOTHERAPY BECAUSE THERE HAD BEEN A DISSECTION OF THE PHA OCCURRED DURING ANGIOGRAPHY. THERE HAD BEEN A FAILURE TO EMBOLIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639472 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention