BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERISET

    MDR report key: 7670822 · Received July 9, 2018

    Report

    Report Number
    1219930-2018-03698
    Event Type
    Injury
    Date Received
    July 9, 2018
    Report Date
    October 3, 2018
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    LMG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCES 1. NATHAN H, SEGEV DL, MAYO SC, CHOTI MA, CAMERON AM, WOLFGANG CL ET AL. (2012) NATIONAL TRENDS IN SURGICAL PROCEDURES FOR HEPATOCELLULAR CARCINOMA: 1998¿2008. CANCER 118:1838¿1844. 2. BOUCHER BA, TRAUB O. (2009) ACHIEVING HAEMOSTASIS IN THE SURGICAL FIELD. PHARMACOTHERAPY 29 (SUPPL. 7 PT 2):2¿7. 3. CARSON JL, POSES RM, SPENCE RK, BONAVITA G. (1988) SEVERITY OF ANAEMIA AND OPERATIVE MORTALITY AND MORBIDITY. LANCET 1:727¿729. 4. DE BOER MT, MOLENAAR IQ, PORTE RJ. (2007) IMPACT OF BLOOD LOSS ON OUTCOME AFTER LIVER RESECTION. DIG SURG 24:259¿264. 5. FARID SG, ALDOURI A, MORRIS-STIFF G, KHAN AZ, TOOGOOD GJ, LODGE JP ET AL. (2010) CORRELATION BETWEEN POSTOPERATIVE INFECTIVE COMPLICATIONS AND LONGTERM OUTCOMES AFTER HEPATIC RESECTION FOR COLORECTAL LIVER METASTASIS. ANN SURG 251:91¿100. 6. SPOTNITZ WD, BURKS S. (2010) STATE-OF-THE-ART REVIEW: HAEMOSTATS, SEALANTS, AND ADHESIVES II: UPDATE AS WELL AS HOW AND WHEN TO USE THE COMPONENTS OF THE SURGICAL TOOLBOX. CLIN APPL THROMB HEMOST 16:497¿ 514. 7. HOWK K, POSTON R, ROUSSELLE S, GROTH D, LISOWSKI M, EDS. EVALUATION OF A NOVEL HAEMOSTATIC PATCH (VERISET¿) FOR USE ON ACTIVELY BLEEDING ANASTOMOSES IN A PORCINE CABG MODEL. INTERACTIVE CARDIOVASCULAR AND THORACIC SURGERY, 20¿22 MAY 2011, MOSCOW. 8. HOWK K, LISOWSKI M, CAWTHRA J, ROUSSELLE S, GARLICK D, ESPAT N, EDS. ASSESSMENT OF ACUTE AND CHRONIC HEPATIC HAEMOSTASIS USING VERISET¿ HAEMOSTATIC PATCH VERSUS SURGICEL¿ NU-KNIT¿ ABSORBABLE HAEMOSTAT IN A PORCINE MODEL. 10TH WORLD CONGRESS OF THE INTERNATIONAL HEPATO- PANCREATO-BILIARY ASSOCIATION, 1¿5 JULY 2012, PARIS. 9. FRILLING A, STAVROU GA, MISCHINGER HJ, DE HEMPTINNE B, ROKKJAER M, KLEMPNAUER J ET AL. (2005) EFFECTIVENESS OF A NEW CARRIER-BOUND FIBRIN SEALANT VERSUS ARGON BEAMER AS HAEMOSTATIC AGENT DURING LIVER RESECTION: A RANDOMIZED PROSPECTIVE TRIAL. LANGENBECKS ARCH SURG 390:114¿120. 10. TORO A, MANNINO M, REALE G, DI CARLO I. (2011) TACHOSIL USE IN ABDOMINAL SURGERY: A REVIEW. J BLOOD MED 2:31¿36. 11. BROOKMEYER R, CROWLEY J. (1982) A CONFIDENCE INTERVAL FOR THE MEDIAN SURVIVAL TIME. BIOMETRICS 38:29¿41. 12. SUISSA S, SHUSTER J. (1985) EXACT UNCONDITIONAL SAMPLE SIZES FOR THE 2 ¥ 2 BINOMIAL TRIAL. J R STAT SOC (SER A) 148:317¿327. 13. KATZ SC, SHIA J, LIAU KH, GONEN M, RUO L, JARNAGIN WR ET AL. (2009) OPERATIVE BLOOD LOSS INDEPENDENTLY PREDICTS RECURRENCE AND SURVIVAL AFTER RESECTION OF HEPATOCELLULAR CARCINOMA. ANN SURG 249:617¿623. 14. YANG T, ZHANG J, LU JH, YANG GS, WU MC, YU WF. (2011) RISK FACTORS INFLUENCING POSTOPERATIVE OUTCOMES OF MAJOR HEPATIC RESECTION OF HEPATOCELLULAR CARCINOMA FOR PATIENTS WITH UNDERLYING LIVER DISEASES. WORLD J SURG 35:2073¿2082. 15. ARIKAWA T, KUROKAWA T, OHWA Y, ITO N, KOTAKE K, NAGATA H ET AL. (2011) RISK FACTORS FOR SURGICAL SITE INFECTION AFTER HEPATECTOMY FOR HEPATOCELLULAR CARCINOMA. HEPATOGASTROENTEROLOGY 58:143¿146. 16. KAIBORI M, ISHIZAKI M, MATSUI K, KWON AH. (2011) POSTOPERATIVE INFECTIOUS AND NON-INFECTIOUS COMPLICATIONS AFTER HEPATECTOMY FOR HEPATOCELLULAR CARCINOMA. HEPATOGASTROENTEROLOGY 58:1747¿1756. 17. DE SANTIBANES E, FERNANDEZ D, VACCARO C, QUINTANA GO, BONADEO F, PEKOLJ J ET AL. (2010) SHORT-TERM AND LONGTERM OUTCOMES AFTER SIMULTANEOUS RESECTION OF COLORECTAL MALIGNANCIES AND SYNCHRONOUS LIVER METASTASES. WORLD J SURG 34:2133¿2140. 18. FONG Y, FORTNER J, SUN RL, BRENNAN MF, BLUMGART LH. (1999) CLINICAL SCORE FOR PREDICTING RECURRENCE AFTER HEPATIC RESECTION FOR METASTATIC COLORECTAL CANCER: ANALYSIS OF 1001 CONSECUTIVE CASES. ANN SURG 230:309¿318; DISCUSSION 318¿321. 19. HOWK K, LISOWSKI M, CAWTHRA J, ROUSSELLE S, GARLICK D, ESPAT N, EDS. IMPROVED HEPATIC HAEMOSTASIS USING VERISET¿ HAEMOSTATIC PATCH VS. SURGICEL¿ NU-KNIT¿ ABSORBABLE HAEMOSTAT. 97TH ANNUAL MEETING OF THE AMERICAN COLLEGE OF SURGEONS, 23¿27 NOVEMBER 2011, SAN FRANCISCO, CA. 20. FRANTZ VK. (1943) ABSORBABLE COTTON, PAPER AND GAUZE: (OXIDIZED CELLULOSE). ANN SURG 118:116¿126. 21. SPANGLER D, ROTHENBURGER S, NGUYEN K, JAMPANI H, WEISS S, BHENDE S. (2003) IN VITRO ANTIMICROBIAL ACTIVITY OF OXIDIZED REGENERATED CELLULOSE AGAINST ANTIBIOTIC-RESISTANT MICROORGANISMS. SURG INFECT (LARCHMT) 4:255¿ 262. 22. VYTRASOVA J, TYLSOVA A, BROZKOVA I, CERVENKA L, PEJCHALOVA M, HAVELKA P. (2008) ANTIMICROBIAL EFFECT OF OXIDIZED CELLULOSE SALTS. J IND MICROBIOL BIOTECHNOL 35:1247¿1252. 23. KUCHTA N, DINEEN P. (1983) EFFECTS OF ABSORBABLE HAEMOSTATS ON INTRAABDOMINAL SEPSIS. INFECT IN SURG 2:441¿444. 24. DILIGENCE M. WORLDWIDE SURGICAL SEALANTS, GLUES AND WOUND CLOSURE MARKET, 2007¿2011. AVAILABLE AT HTTP://WWW.MEDILIGENCE.COM/RPT/RPTS145. HTM (LAST ACCESSED 10 DECEMBER 2012). 25. GILLISS BM, LOONEY MR, GROPPER MA. (2011) REDUCING NON-INFECTIOUS RISKS OF BLOOD TRANSFUSION. ANESTHESIOLOGY 115:635¿649. 26. SHANDER A. (2007) FINANCIAL AND CLINICAL OUTCOMES ASSOCIATED WITH SURGICAL BLEEDING COMPLICATIONS. SURGERY 142 (4 SUPPL.):20¿25. 27. KAPOOR S, NUNDY S. (2012) BILE DUCT LEAKS FROM THE INTRAHEPATIC BILIARY TREE: A REVIEW OF ITS AETIOLOGY, INCIDENCE, AND MANAGEMENT. HPB SURG 2012:752932. 28. NIRAJ P, MICHAEL M, LOBAT H, AMEER A. RESOURCE UTILIZATION AND COSTS ASSOCIATED WITH PERIOPERATIVE BLOOD LOSS DURING LIVER SURGERIES. A RETROSPECTIVE DATA ANALYSIS IN THE UNITED STATES. 10TH WORLD CONGRESS OF THE INTERNATIONAL HEPATO-PANCREATO-BILIARY ASSOCIATION, 1¿5 JULY 2012, PARIS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, A STUDY WAS MADE REGARDING THE SAFETY AND EFFECTIVENESS OF A SYNTHETIC HEMOSTATIC PATCH FOR SOFT TISSUE BLEEDING DURING A VARIETY OF SURGICAL PROCEDURES. TIME TO HEMOSTASIS WAS MONITORED, AND ADVERSE EVENTS WERE ASSESSED DURING THE 90 DAYS AFTER SURGERY. WITHIN THE PRESENTED SUBJECTS, ONE WAS LOST TO FOLLOW-UP AND THE OTHER DIED DURING THE STUDY FROM EMBOLIC COMPLICATIONS OF A PRE-EXISTING ATRIAL THROMBUS THAT WAS UNRELATED TO THE TEST OF DEVICE. IN ONE SUBJECT WITH ANEMIA, THE ADVERSE EVENT WAS ADJUDICATED BY THE INDEPENDENT MEDICAL MONITOR AS HAVING AN UNKNOWN OR IMPOSSIBLE TO DETERMINE RELATIONSHIP WITH THE DEVICE. ANOTHER SUBJECT DOES NOT ACHIEVED HEMOSTASIS AFTER 2 MINUTES AND AN ALTERNATIVE TOPICAL AGENT WAS ADMINISTERED. IN ANOTHER SUBJECT, HEMOSTASIS WAS ACHIEVED BUT LATER IN THE PROCEDURE, IT DETACHED DURING A GASTRIC PULL-UP MANEUVER. NO TISSUE DAMAGE WAS OBSERVED IN THESE TWO SUBJECTS. ANOTHER SUBJECT, THE PATCH WAS LATER REMOVED WHEN THE INITIAL TBS WAS EXTRACTED ALONG WITH AN ORGAN BECAUSE OF A PROCEDURAL COMPLICATIONS UNRELATED TO THE USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513563 VERISET AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG COVIDIEN LP LLC NORTH HAVEN UNKNOWN VERISET

    Patients

    Seq Age Sex Outcome Treatment
    1 Other