BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 12541465 · Received September 28, 2021

    Report

    Report Number
    2210968-2021-08911
    Event Type
    Injury
    Date Received
    September 28, 2021
    Date of Event
    August 19, 2020
    Report Date
    September 10, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: TECHNIQUES IN COLOPROCTOLOGY (2020) 24:1277¿1283. HTTPS://DOI.ORG/10.1007/S10151-020-02325-3.

    Description of Event or Problem · 1

    TITLE: PORCINE DERMAL COLLAGEN MESH (PERMACOL¿) AS A BIOPROSTHESIS IN THE LIGATION OF INTERSPHINCTERIC TRACT (BIOLIFT) PROCEDURE. THE AIM OF THIS STUDY WAS TO COMPARE THE SUCCESS RATES OF LIFT AND BIOLIFT FOR COMPLEX ANAL FISTULAS USING THE PERMACOL¿ BIOLOGICAL MESH. A TOTAL OF 58 PATIENTS FROM JANUARY 2010 TO NOVEMBER 2019 WHO HAD EITHER LIGATION OF INTERSPHINCTERIC TRACT (LIFT ;N=48) OR BIOPROSTHESIS IN LIFT (BIOLIFT ;N=10) FOR TRANSPHINCTERIC FISTULAS WERE INCLUDED. THE MEAN AGE WAS 48 (RANGE: 22¿73) YEARS. THE MAJORITY OF PATIENTS WERE MALE 47 (81%). THERE WAS NO SIGNIFICANT DIFFERENCE IN AGE, SEX, BODY MASS INDEX OR SMOKING BETWEEN THE TWO GROUPS. IN BRIEF, ALL PATIENTS WERE PLACED IN THE PRONE JACKKNIFE POSITION WITH RETRACTION OF THE BUTTOCKS BY ADHESIVE TAPES. EXAMINATION UNDER ANESTHESIA (EUA) WAS PERFORMED TO DETERMINE THE DEGREE OF ANAL SPHINCTER INVOLVEMENT. IF NO SETON WAS INSERTED PREVIOUSLY, THE FISTULA WAS CANNULATED USING LOCKHART¿MUMMERY PROBES. A SILICONE VESSEL LOOP WAS THREADED THROUGH ONCE THE FISTULA TRACT WAS IDENTIFIED. A CURVILINEAR SKIN INCISION WAS MADE OVER THE INTERSPHINCTERIC GROOVE. THE LONE STAR DISPOSABLE SELF-RETAINING RETRACTING SYSTEM (COOPER SURGICAL, INC., TRUMBULL, CT, USA) WAS USED TO AID VISUALIZATION AND DISSECTION OF THE FISTULA TRACT. A COMBINATION OF SHARP AND BLUNT DISSECTION WITH S-SHAPED RETRACTORS WAS USED TO ISOLATE THE FISTULA TRACT WHICH WAS THEN SLUNG WITH SILICONE VESSEL LOOP. SUTURE LIGATION OF THE FISTULA TRACT WAS PERFORMED AT PROXIMAL AND DISTAL ENDS (ENTRANCE INTO THE EXTERNAL AND INTERNAL SPHINCTER IN THE INTERSPHINCTERIC PLANE) USING 4¿0 VICRYL SUTURES. THE TRACT WAS DIVIDED WITH OR WITHOUT EXCISION OF A SEGMENT OF THE FISTULA TRACT. THE MUSCLE DEFECT MEDIAL TO THE EXTERNAL ANAL SPHINCTER WAS SUTURED AND APPROXIMATED. THE PERIANAL INCISION WAS CLOSED WITH INTERRUPTED 4¿0 VICRYL SUTURES TO COMPLETE THE PROCEDURE. THE INITIAL STEPS OF THE BIOLIFT PROCEDURE WERE SIMILAR TO LIFT. AFTER IDENTIFICATION AND LIGATION OF THE FISTULA TRACT, A PERMACOL¿ (MEDTRONIC, MINNEAPOLIS, MN, USA) MESH, SIZED 3 × 3 CM), WAS INSERTED INTO THE INTERSPHINCTERIC PLANE IN BETWEEN THE DIVIDED ENDS OF THE TRACT. THE MESH WAS SECURED USING 3/0 VICRYL SUTURES. THE SKIN WAS CLOSED COVERING THE MESH USING 4/0 VICRYL SUTURES. THE EXTERNAL OPENING WAS LEFT OPEN FOR DRESSING. ALL BIOLIFT PATIENTS HAD PREVIOUS INTERVENTIONS FOR THEIR FISTULAS COMPARED TO 30 (62.5%) OF PATIENTS WHO HAD LIFT, P = 0.023. THE PRIMARY HEALING RATE FOR LIFT WAS 87.5% (42/48) COMPARED TO 80% (8/10) IN BIOLIFT, (P = 0.42). EIGHT (13.8%) PATIENTS DEVELOPED COMPLICATIONS, 6 (12.5%) IN THE LIFT GROUP VS 2 (20%) IN THE BIOLIFT GROUP (P = 0.62). BIOLIFT WAS NOT ASSOCIATED WITH COMPLICATION (OR = 1.75, 95% CI: 0.30¿10.3, P = 0.54) OR PRIMARY HEALING (OR = 0.57, 95% CI: 0.97¿3.36, P = 0.54). THERE WAS NO SIGNIFICANT DIFFERENCE IN RECURRENCE (LIFT 12.5% VS BIOLIFT 0%, P = 0.58). KAPLAN¿MEIER ANALYSIS FOUND NO DIFFERENCE IN TIME TO RECURRENCE BETWEEN THE TWO GROUPS (P = 0.65). REPORTED POSTOPERATIVE COMPLICATIONS INCLUDED N=5 PAIN, N=1 INCONTINENCE, N=6 RECURRENCE, N=1 BLEEDING AND N=1 CONSTIPATION. IN CONCLUSION, PERMACOL¿ MESH IN BIOLIFT IS FEASIBLE AND ACHIEVES A HIGH PRIMARY HEALING RATE OF 80%. PROSPECTIVE EVIDENCE IS NEEDED TO ESTABLISH THE BENEFITS OF BIOLIFT AND DETERMINE WHETHER PERMACOL¿ IS SUPERIOR TO THE NON-CROSS-LINKED PORCINE SUBMUCOSAL MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1440105 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1