BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN

    MDR report key: 4383558 · Received December 31, 2014

    Report

    Report Number
    1037905-2014-00518
    Event Type
    Death
    Date Received
    December 31, 2014
    Report Date
    December 5, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    MND
    PMA / PMN Number
    K944220
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD FROM THIS LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSIONS: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. SLIPPAGE OF THE BAND FORM THE VARIX CAN OCCUR IF THE ENDOSCOPE IS ADVANCED BEYOND THE BANDED SITE. THE INSTRUCTIONS FOR USE ADVISED THE USER THAT PASSING THE ENDOSCOPE OVER A PREVIOUSLY PLACED BAND MAY DISLODGE THE BAND. THE INSTRUCTIONS FOR USE CAUTION THE USER NOT TO APPLY ALCOHOL TO THE DEVICE. APPLICATION OF AN ALCOHOL-BASED LUBRICANT OR OTHER SUBSTANCE COULD HAVE CONTRIBUTED TO THE REPORTED OCCURRENCE. PRIOR TO DISTRIBUTION, ALL SAEED MULTI-BAND LIGATORS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: THE NEED FOR CORRECTIVE ACTIONS IS STILL TO BE DETERMINED. WE ARE IN THE PROCESS OF GATHERING MORE INFORMATION REGARDING THE DESCRIPTION OF THE EVENT AND PT OUTCOME IN ORDER TO DETERMINE IF CORRECTIVE ACTIONS ARE REQUIRED. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THAT INFORMATION IS RECEIVED. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    INFORMATION PROVIDED FORM THE FOLLOWING CLINICAL LITERATURE: VANBIERVLIET G., GUIDICELLI-BORNARD S., PICHE T., ET AL. PREDICTIVE FACTOR OF BLEEDING RELATED TO POST-BANDING ULCER FOLLOWING ENDOSCOPIC VARICEAL LIGATION IN CIRRHOTIC PTS: A CARE-CONTROL STUDY. ALIMENTARY PHARMACOLOGY AND THERAPEUTICS 2010; 32: 225-232. CASE CONTROL STUDY OF PTS WHO UNDERWENT ESOPHAGEAL VARICEAL LIGATION (EVL) BETWEEN THE TIMEFRAME 2002 TO 2007: AMONG SIX HUNDRED AND FIVE (605) CIRRHOTIC PTS, 21 PTS (MEAN AGE 56.6 YEARS +/- 13.5 YEARS) DEVELOPED 23 SPONTANEOUS BAND SLIPPAGES WITH BLEEDING ON POST BANDING ULCER, AS CONFIRMED BY ENDOSCOPY. BLEEDING OCCURRED 13.5 DAYS +/- 7.3 (2-29) FOLLOWING LIGATION. CASES WERE DEFINED AS CIRRHOTIC PTS WHO DEVELOPED A DIGESTIVE BLEEDING RELATED TO ULCERS AFTER SPONTANEOUS SLIPPAGE OF RUBBER BAND FOLLOWING A FIRST EVL PERFORMED IN EMERGENCY OR PROPHYLACTIC SITUATION. TWENTY ONE PTS (17 MEN AND 4 WOMEN, PRESENTED 23 BLEEDING EPISODES FOLLOWING EVL IN RELATION TO ULCERS AFTER SLIDING OF RUBBER BAND, BUT ONLY 17 PTS (81 PERCENT) THE HEMORRHAGE DEVELOPED FOLLOWING A FIRST LIGATION [AND IN FOUR PTS (19 PERCENT) FOLLOWING A SECOND SESSION OF LIGATION]. TREATMENT OF THE BLEEDING RELATED TO POST BANDING ULCER AFTER SPONTANEOUS SLIPPAGE OF RUBBER BAND: IN ALL CASE PTS, OCTREOTIDE (25 MICROGRAM PER HOUR) AND PPI (PROTEIN PUMP INHIBITOR) DOSE INFUSION (ESOMEPRAZOLE - 40 MG PER DAY) WERE GIVEN FOR FIVE DAYS AFTER THE BLEEDING COMPLICATION. ALL PTS RECEIVED PROPHYLACTIC ANTIBIOTHERAPY (OFLOXACINE - ANTIBIOTIC) AND THE GASTROSCOPY WAS PERFORMED IN THE SIX FIST HOURS AFTER ADMISSION. CYANOACRYLATE ENDOSCOPIC INJECTIONS WERE PERFORMED IN 10 PTS (43 PERCENT), FIVE PTS (24 PERCENT) HAD OESOPHAGEAL BALLOON TAMPONADE (FOR CONTROLLED AND MASSIVE BLEEDING WITH HAEMODYNAMIC DEFICIENCY) AND 2 PTS HAD AN EMERGENCY TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNTS (TIPPS). THE 11 PTS DIED FOLLOWING THE BLEEDING COMPLICATION. IN CONCLUSION, THE BLEEDING OF ULCER BECAUSE OF SPONTANEOUS SLIPPAGE OF RUBBER BAND AFTER EVL IS A SERIOUS COMPLICATION IN WHICH FATAL OUTCOME SEEMS TO BE INFLUENCED IN THE MAJORITY OF CASES BY A SEPSIS. ETIOLOGY OF DEATHS: 5 = SEPSIS, 3 = HEPATIC INSUFFICIENCY, 3 = UNCONTROLLED BLEED. THE 11 OF THE 21 PTS DYING WITHIN A FEW DAYS AND IN THE MAJORITY OF CASES (FIVE PTS), SECONDARY TO A SEPSIS (ONE SPONTANEOUS BACTERIAL PERITONITIS, TWO PNEUMONIA AND TWO SEPTICAEMIA. SEVEN OF THE 11 PTS WHO DIED DID NOT RECEIVE PROPHYLACTIC ANTIBIOTHERAPY DURING THE EVL SESSION INDUCING THE POST BANDING ULCER. IN UNIVARIABLE ANALYSIS, THE DEVELOPMENT OF A SEPSIS DURING THE EVOLUTION WAS THE ONLY PREDICTIVE FACTOR OF FATAL OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862408 UNKNOWN MND, LIGATOR, ESOPHAGEAL MND WILSON-COOK MEDICAL INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death ENDOSCOPE (UNK MODEL NUMBER)