BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFUSION PUMP

    MDR report key: 2462277 · Received February 21, 2012

    Report

    Report Number
    3007566237-2012-00368
    Event Type
    Death
    Date Received
    February 21, 2012
    Report Date
    February 1, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DATES OF DEATH WERE NOT PROVIDED. THIS DATE IS AN ESTIMATE BASED ON THE DATE THE ARTICLE WAS RECEIVED FOR PUBLICATION. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PATIENT. THE PATIENT INFORMATION PROVIDED IS THE AVERAGE FOR ALL THE PATIENTS. AT THE TIME OF THIS REPORT, NO ADDITIONAL INFORMATION WAS AVAILABLE, ADDITIONAL INFORMATION REGARDING THE PATIENT, EVENT, INTERVENTIONS, AND OUTCOME HAS BEEN REQUESTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RAUT, V., MORI, A., KAIDO, T., OGURA, Y., TAKU, I., NAGAI, K., SASAKI, N., ENDO, K., HATA, T, YAGI, S., EGAWA, H., UEMOTO, S. SPLENECTOMY DOES NOT OFFER IMMUNOLOGICAL BENEFITS IN ABO-INCOMPATIBLE LIVER TRANSPLANTATION WITH A PREOPERATIVE RITUXIMAB. TRANSPLANTATION 2012; 93: 99-105. DOI: 10.1097/TP.0BO13E318239E8E4. SUMMARY: PREFORMED ANTI-ABO ANTIBODIES ARE PRIMARILY RESPONSIBLE FOR ANTIBODY-MEDIATED REJECTION (AMR) AFTER ABO INCOMPATIBLE(ABO-I) LIVER TRANSPLANTATION (LT) RESULTING IN LETHAL HEPATIC NECROSIS AND BILIARY COMPLICATIONS. SPLENECTOMY, AN INTEGRAL PART OF PROTOCOL FOR ABO-I LT, DECREASES ANTI-ABO ANTIBODIES. WITH THE PREOPERATIVE RITUXIMAB PROPHYLAXIS, ROLE OF THE SPLENECTOMY FOR ABO-I LT IS NOW UNDER DEBATE. WE INVESTIGATED THE NECESSITY OF SPLENECTOMY BY RETROSPECTIVE ANALYSES OF THE SHORT-TERM ANTI-ABO ANTIBODY RESPONSE AND LONG-TERM OUTCOMES OF ABO-I LT. THIRTY-SEVEN ABO-I LTS PERFORMED FROM (B)(6) 2006 THROUGH (B)(6) 2009, AT (B)(6) HOSPITAL, WERE RETROSPECTIVELY ANALYZED. TWENTY-SEVEN PATIENTS WHO UNDERWENT SPLENECTOMY (SPLENECTOMY GROUP) RECEIVED 329.6+/-35.8 MG RITUXIMAB 17.7+/-11.9 DAYS BEFORE LIVING DONOR LT. TEN PATIENTS WITHOUT SPLENECTOMY (NONSPLENECTOMY GROUP) RECEIVED 320.0+/-10.3 MG RITUXIMAB 26.6_21.3 DAYS BEFORE TRANSPLANTATION. ALL PATIENTS RECEIVED A POST-TRANSPLANT HEPATIC ARTERY INFUSION WITH PROSTAGLANDIN E1 AND METHYLPREDNISOLONE. FOR ALL PATIENTS, HEPATIC ARTERY INFUSION STARTED DURING OPERATION AFTER THE RECONSTRUCTION OF HEPATIC ARTERY, USING PROSTAGLANDIN E1 AT THE INITIAL DOSE OF .005MCG/KG/MIN AND A MAINTENANCE DOSE OF .01MCG/KG/MIN FROM POST-OPERATIVE DAY 1 TO 21 AND 125MG/DAY METHYLPREDNISOLONE FOR FIRST 7 DAYS. PERIOPERATIVE ANTI-ABO IMMUNOGLOBULIN M AND IMMUNOGLOBULIN G ANTIBODY TITERS, REJECTIONS, BILIARY COMPLICATIONS, INFECTIONS, AND SURVIVAL RESULTS WERE COMPARED. PREOPERATIVE RITUXIMAB WITH PLASMA EXCHANGE EFFECTIVELY REDUCED ANTI-ABO ANTIBODIES IN BOTH PATIENT GROUPS AT THE TIME OF LT. THERE WAS NO STATISTICALLY SIGNIFICANT DIFFERENCE OBSERVED IN ANTI-ABO IMMUNOGLOBULIN M AND IMMUNOGLOBULIN G ANTIBODY TITERS BETWEEN THE "SPLENECTOMY" AND "NONSPLENECTOMY" GROUPS DURING THE INITIAL 8 WEEKS. THE CLINICAL OUTCOMES, INCLUDING AMR, BILIARY COMPLICATIONS, INFECTIONS, AND SURVIVAL, WERE SIMILAR IN BOTH THE GROUPS. PREOPERATIVE RITUXIMAB EFFECTIVELY DECREASED THE ANTI-ABO ANTIBODIES SUFFICIENTLY TO PREVENT THE AMR IRRESPECTIVE OF SPLENECTOMY. SPLENECTOMY DOES NOT OFFER ANY IMMUNOLOGICAL BENEFIT IN ABO-I LT WITH PREOPERATIVE RITUXIMAB. REPORTED EVENTS: TWO PATIENTS IN THE NON-SPLENECTOMY GROUP EXPERIENCED BLEEDING RELATED TO CATHETER REMOVAL, RESULTING IN DEATH. TWO PATIENTS IN THE NON-SPLENECTOMY GROUP EXPERIENCED BLEEDING RELATED TO THE CATHETER AND REQUIRED RE-EXPLORATION. ONE PATIENT IN THE NON-SPLENECTOMY GROUP DIED AS A RESULT OF BOWEL PERFORATION. TWO PATIENTS IN THE SPLENECTOMY GROUP DIED AS A RESULT OF SEPSIS. THREE PATIENTS IN THE NON-SPLENECTOMY GROUP EXPERIENCED CATHETER-RELATED SEPSIS. TWO PATIENTS IN THE NON-SPLENECTOMY GROUP EXPERIENCED WOUND INFECTION. SIX PATIENTS IN THE NON-SPLENECTOMY GROUP EXPERIENCED CHOLANGITIS. SIXTEEN PATIENTS IN THE SPLENECTOMY GROUP EXPERIENCED CHOLANGITIS. THREE PATIENTS IN THE SPLENECTOMY GROUP EXPERIENCED PRIMARY BACTEREMIA. TWO PATIENTS IN THE SPLENECTOMY GROUP EXPERIENCED WOUND INFECTION ONE PATIENT WHO HAD INTRACEREBRAL HEMORRHAGE ON POST-OP DAY 3 AND DIED ON POST-OP DAY 14 WAS EXCLUDED FROM THE STUDY. FURTHER INFORMATION HAS BEEN REQUESTED AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    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 00048 YR Death| R CATHETER MODEL NEU_UNKNOWN_CATH LOT# UNKNOWN