BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSORBATACK

    MDR report key: 7664908 · Received July 5, 2018

    Report

    Report Number
    1219930-2018-03632
    Event Type
    Injury
    Date Received
    July 5, 2018
    Report Date
    July 5, 2018
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCES 1. BOSANQUET D, ABOELRAHMAN T, ANSELL J, CORNISH J, DAVIES L, FREWER K, FREWER N, GLASBEY J, HARRIES R, STIMPSON A, RUSSELL D, RUSSELL I, TORKINGTON J. SYSTEMATIC REVIEW AND META REGRESSION OF FACTORS AFFECTING MIDLINE INCISIONAL HERNIA RATES: AN ANALYSIS OF 14,618 PATIENTS. HERNIA 2014; 18(SUPPL 2):S12¿S15. 2. ALNASSAR S, BAWAHAB M, ABDOH A, GUZMAN R, AL TUWAIJIRI T, LOURIDAS G. INCISIONAL HERNIA POSTREPAIR OF ABDOMINAL LAPAROSCOPIC INCISIONAL HERNIA REPAIR 391 AORTIC OCCLUSIVE AND ANEURYSMAL DISEASE: FIVE-YEAR INCIDENCE. VASCULAR 2012;20:273¿277. 3. POULOSE BK, SHELTON J, PHILLIPS S, MOORE D, NEALON W, PENSON D, BECK W, HOLZMAN MD. EPIDEMIOLOGY AND COST OF VENTRAL HERNIA REPAIR: MAKING THE CASE FOR HERNIA RESEARCH. HERNIA 2012;16:179¿183. 4. SAUERLAND S, WALGENBACH M, HABERMALZ B, SEILER CM, MISEREZ M. LAPAROSCOPIC VERSUS OPEN SURGICAL TECHNIQUES FOR VENTRAL OR INCISIONAL HERNIA REPAIR. COCHRANE DATABASE SYST REV 2011;3:CD007781. 5. MUYSOMS FE, MISEREZ M, BERREVOET F, CAMPANELLI G, CHAMPAULT GG, CHELALA E, DIETZ UA, EKER HH, EL NAKADI I, HAUTERS P, HIDALGO PASCUAL M, HOEFERLIN A, KLINGE U, MONTGOMERY A, SIMMERMACHER RK, SIMONS MP, SMIETAN ´SKI M, SOMMELING C, TOLLENS T, VIERENDEELS T, KINGSNORTH A. CLASSIFICATION OF PRIMARY AND INCISIONAL ABDOMINAL WALL HERNIAS. HERNIA 2009;13:407¿414. 6. LEBLANC KA, BOOTH WV. LAPAROSCOPIC REPAIR OF INCISIONAL ABDOMINAL HERNIAS USING EXPANDED POLYTETRAFLUOROETHYLENE: PRELIMINARY FINDINGS. SURG. LAPAROSC ENDOSC 1993;3:39¿41. 7. LEBLANC KA, BOOTH WV, WHITAKER JM. LAPAROSCOPIC INCISIONAL AND VENTRAL HERNIORRHAPHY: OUR INITIAL 100 PATIENTS. AM J SURG 2000;180:193¿197. 8. AL CHALABI H, LARKIN J, MEHIGAN B, MCCORMICK P. A SYSTEMATIC REVIEW OF LAPAROSCOPIC VERSUS OPEN ABDOMINAL INCISIONAL HERNIA REPAIR, WITH META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS. INT J SURG 2015;20:65¿74. 9. WORMER BA, WALTERS AL, BRADLEY JF 3RD, WILLIAMS KB, TSIRLINE VB, AUGENSTEIN VA, HENIFORD BT. DOES VENTRAL HERNIA DEFECT LENGTH, WIDTH, OR AREA PREDICT POSTOPERATIVE QUALITY OF LIFE? ANSWERS FROM A PROSPECTIVE, INTERNATIONAL STUDY. J SURG RES 2013;184:169¿177. 10. ROSS SW, WORMER BA, KIM M, OOMMEN B, BRADLEY JF, LINCOURT AE, AUGENSTEIN VA, HENIFORD BT. DEFINING SURGICAL OUTCOMES AND QUALITY OF LIFE IN MASSIVE VENTRAL HERNIA REPAIR: AN INTERNATIONAL MULTICENTER PROSPECTIVE STUDY. AM J SURG 2015;210:801¿813. 11. FINAN KR, VICK CC, KIEFE CI, NEUMAYER L, HAWN MT. PREDICTORS OF WOUND INFECTION IN VENTRAL HERNIA REPAIR. AM J SURG 2005;190:676¿681. 12. KAAFARANI HM, KAUFMAN D, REDA D, ITANI KM. PREDICTORS OF SURGICAL SITE INFECTION IN LAPAROSCOPIC AND OPEN VENTRAL INCISIONAL HERNIORRHAPHY. J SURG RES 2010;163:229¿234. 13. DUNNE JR, MALONE DL, TRACY JK, NAPOLITANO LM. ABDOMINAL WALL HERNIAS: RISK FACTORS FOR INFECTION AND RESOURCE UTILIZATION. J SURG RES 2003;111:78¿84. 14. THE´RIN M, MUTTER D, DIEMUNSCH P, RODEHEAVER GT. PRECLINICAL EVALUATION OF A NEW COMPOSITE MESH (COLLAGENPOLYESTER) FOR INTRAPERITONEAL HERNIA REPAIR WITH THE SELECTIVE PROPERTY OF TISSUE INCORPORATION ON ONE SIDE WITHOUT ADHESION FORMATION ON THE OPPOSITE SIDE (ABSTRACT 22). HERNIA 1998;2(SUPPL 2):S27. 15. MCGINTY JJ, HOGLE NJ, MCCARTHY H, FOWLER DL. A COMPARATIVE STUDY OF ADHESION FORMATION AND ABDOMINAL WALL INGROWTH AFTER LAPAROSCOPIC VENTRAL HERNIA REPAIR IN A PORCINE MODEL USING MULTIPLE TYPES OF MESH. SURG ENDOSC 2005; 19:786¿790. 16. BEN-HAIM M, KURIANSKY J, ZMORA O, MINTZ Y, ROSIN D, AYALON A, SHABTAI M. PITFALLS AND COMPLICATIONS WITH LAPAROSCOPIC INTRAPERITONEAL EXPANDED POLYTETRAFLUOROETHYLENE PATCH REPAIR OF POSTOPERATIVE VENTRAL HERNIA. SURG ENDOSC 2002;16:785¿788. 17. BERGER D, BIENTZLE M, MULLER A. POST-OPERATIVE COMPLICATIONS AFTER LAPAROSCOPIC INCISIONAL HERNIA REPAIR. INCIDENCE AND TREATMENT. SURG ENDOSC 2002;16:1720¿1723. 18. DUMANIAN GA, DENHAM W. COMPARISON OF REPAIR TECHNIQUES FOR MAJOR INCISIONAL HERNIAS. AM J SURG 2003;185: 61¿65. 19. KOEHLER RH, VOELLER G. RECURRENCES IN LAPAROSCOPIC INCISIONAL HERNIA REPAIRS: A PERSONAL SERIES AND REVIEW OF THE LITERATURE. J SOC LAPAROENDOSC SURG 1999;3:293¿304. 20. OLMI S, ERBA L, MAGNONE S, BERTOLINI A, CROCE E. PROSPECTIVE CLINICAL STUDY OF LAPAROSCOPIC TREATMENT OF INCISIONAL AND VENTRAL HERNIA USING A COMPOSITE MESH: INDICATIONS, COMPLICATIONS AND RESULTS. HERNIA 2006;10:243¿247. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, IN LAPAROSCOPIC INCISIONAL HERNIA REPAIR, A HIGHER RATE OF RECURRENCE WAS OBSERVED IN THE TACK GROUP (10.0%) THAN IN THE NON-ABSORBABLE FIXATION DEVICES, FOR THIS REASON, THEY¿VE LIMITED THE NUMBER OF PATIENTS TREATED WITH THE TACK. REGARDING THE FIXATION DEVICES, THE TACK SYSTEM SEEMED TO BE LESS RELATED TO POSTOPERATIVE NEURALGIA, BUT WAS RELATED TO A HIGHER RATE OF RECURRENCE THAN NON-ABSORBABLE SYSTEMS. THE DEVICE WAS USED ON 30 PATIENTS. THE RECURRENCE RATE WAS 2.4% (12 PATIENTS) WITH THE MAJORITY OBSERVED IN THE ABSORBABLE TACK GROUP (10%).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504969 ABSORBATACK STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN ABSORBATACK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other