BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRONOVA BLUE SUTURE UNKNOWN PRODUCT

    MDR report key: 7490350 · Received May 7, 2018

    Report

    Report Number
    2210968-2018-72624
    Event Type
    Death
    Date Received
    May 7, 2018
    Report Date
    April 13, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K001625
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS AND PATIENT DEATHS DESCRIBED IN THE ARTICLE? WAS HEMORRHAGE DUE TO ANY DEFICIENCY IN THE SUTURE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? PLEASE CONTACT THE AUTHOR/ SURGEON TO OFFER A CONVERSATION WITH ETHICON MEDICAL AND ENGINEERING. CITATION: WORLD J SURG (2012) 36:1858¿1865, DOI 10.1007/S00268-012-1567-3; PUBLISHED ONLINE: 27 MARCH 2012. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: PREOPERATIVE PANCREAS CT/MRI CHARACTERISTICS PREDICT FISTULA RATE AFTER PANCREATICODUODENECTOMY AUTHORS: F. FROZANPOR, L. LOIZOU, C. ANSORGE, R. SEGERSVA¨RD, L. LUNDELL AND N. ALBIIN CITATION: WORLD J SURG (2012) 36:1858¿1865, DOI 10.1007/S00268-012-1567-3; PUBLISHED ONLINE: 27 MARCH 2012. THE AIM OF THIS STUDY WAS TO TEST THE HYPOTHESIS THAT THE PANCREATIC REMNANT VOLUME (PRV), PREOPERATIVELY ESTIMATED, COULD BE AN IMPORTANT DETERMINANT OF PANCREATIC FISTULA (PF) RATE AFTER PANCREATICODUODENECTOMY (PD). A TOTAL OF 182 PATIENTS (88 MALES AND 94 FEMALES) AGED 22 TO 87 WITH BMI RANGE OF 15.0 TO 47.4 UNDERGOING PD BETWEEN SEPTEMBER 2007 AND NOVEMBER 2010 WERE INCLUDED IN THE STUDY. THE DIAGNOSIS WAS MALIGNANT IN 144 PATIENTS (79.1 %) AND BENIGN IN 38 (20.9 %). PANCREATIC FISTULA DEFINED ACCORDING TO THE INTERNATIONAL STUDY GROUP ON PANCREATIC FISTULA (ISGPF) CRITERIA WAS DIAGNOSED IN 37 PATIENTS (20.3 %). DURING THE PROCEDURE, AN END-TO-SIDE DUCT-TO-MUCOSA PANCREATICOJEJUNOSTOMY WAS COMPLETED, WITH THE INNER LAYER OF THE ANASTOMOSIS COMPLETED WITH 5-0 OR 6-0 SUTURES (PRONOVA, ETHICON, (B)(4)). THE OUTER LAYER, CONSISTING OF THE REMNANT PANCREAS PARENCHYMA AND THE SEROMUSCULAR LAYER OF THE JEJUNUM, WERE COATED WITH 4-0 OR 5-0 SUTURES. ALL DRAIN FLUIDS AND OTHER COLLECTIONS WERE ANALYZED DAILY FOR HEMOGLOBIN, BILIRUBIN, AND AMYLASE. IN TOTAL, 120 PATIENTS (65.9 %) EXPERIENCED POSTOPERATIVE COMPLICATIONS AND 31 (17 %) OF THEM HAD A SEVERE COMPLICATION. THE MOST COMMON SURGICAL COMPLICATION WAS A PF, WHICH WAS OBSERVED IN 38 PATIENTS (20.9 %) AND 14 OF THESE WERE GRADE C FISTULAS. EIGHT OF 24 PATIENTS WITH INTRA-ABDOMINAL ABSCESSES HAD NO APPARENT PANCREATIC LEAKAGE (NO DRAINAGE OF AMYLASE-CONTAINING FLUID). THE OCCURRENCE OF A PF INCREASED THE MEAN PERIOD OF HOSPITAL CARE FROM 14.3 ± 7.6 TO 30 ± 27.7 DAYS (OR 1.07, 95% CI 1.03¿1.10, P\0.01). TWENTY-FOUR (13 %) PATIENTS REQUIRED REOPERATION. ELEVEN WERE RE-OPERATED DUE TO A GRADE C FISTULA AND SEVEN OF THESE REQUIRED SEVERAL PROCEDURES. THE OTHER 14 WERE EARLY REOPERATIONS FOR BILE LEAKAGE (4), INTRA-ABDOMINAL BLEEDING (3), INTRALUMINAL BLEEDING (4), AND LATER WOUND DEHISCENCE (3). THREE (1.6 %) PATIENTS DIED ON THE 9TH, 10TH, AND 23RD POSTOPERATIVE DAY, RESPECTIVELY. TWO HAD A PF WITH UNCONTROLLABLE HEMORRHAGE, AND ONE DIED SUDDENLY AFTER MYOCARDIAL INFARCTION WITHOUT POSTOPERATIVE COMPLICATIONS. IN CONCLUSION, THE PRESENT STUDY SHOWS THAT IT IS POSSIBLE AND RELEVANT TO CALCULATE THE PRV AND THE PANCREATIC DUCT WIDTH (PDW) PREOPERATIVELY, BY USING COMPUTED TOMOGRAPHY (CT) AND MAGNETIC RESONANCE IMAGING (MRI), AND THEREBY PREDICT PF FORMATION AFTER PD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333738 PRONOVA BLUE SUTURE UNKNOWN PRODUCT SUTURE, NON ABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death