BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 8771948 · Received July 9, 2019

    Report

    Report Number
    2210968-2019-83798
    Event Type
    Injury
    Date Received
    July 9, 2019
    Report Date
    June 27, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    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. CITATION: INT J COLORECTAL DIS (2004) 19:359¿369; DOI 10.1007/S00384-003-0572-2. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: NEW TRENDS IN THE SURGICAL TREATMENT OF OUTLET OBSTRUCTION: CLINICAL AND FUNCTIONAL RESULTS OF TWO NOVEL TRANSANAL STAPLED TECHNIQUES FROM A RANDOMISED CONTROLLED TRIAL". AUTHOR(S): PAOLO BOCCASANTA, MARCO VENTURI, GIOVANNI SALAMINA, BRUNO MARIO CESANA, FRANCESCO BERNASCONI, GIANCARLO ROVIARO. CITATION: INT J COLORECTAL DIS (2004) 19:359¿369; DOI 10.1007/S00384-003-0572-2. THE AIM OF THIS RANDOMISED TRIAL WAS TO COMPARE THE CLINICAL AND FUNCTIONAL RESULTS OF THESE TWO NOVEL TECHNIQUES IN PATIENTS WITH OUTLET OBSTRUCTIVE SYNDROME (OOS) ASSOCIATED WITH INTUSSUSCEPTION AND RECTOCELE ON POSTOPERATIVE PAIN, ANORECTAL MANOMETRY DATA AND SIGNS AND SYMPTOMS FROM THE CONSTIPATION SCORING AND CONTINENCE GRADING SYSTEMS. FROM OCT1999 TO OCT2001, 50 FEMALE PATIENTS WITH OOS WERE RANDOMIZED AND ALLOCATED INTO TWO GROUPS: STAPLED TRANS-ANAL PROLAPSECTOMY, WITH PERINEAL LEVATORPLASTY (STAPL) (N=25; MEAN AGE 53.2±15.3 YEARS), AND DOUBLE STAPLED TRANS-ANAL RECTAL RESECTION (STARR) (N=25; MEAN AGE 54.6±14.2 YEARS). IN STAPL GROUP, CIRCULAR STAPLER WITH A DISPOSABLE CIRCULAR ANAL DILATOR AND A PURSE-STRING SUTURE ANOSCOPE (PPH-01) (ETHICON-ENDOSURGERY, POMEZIA, ITALY) WAS USED. AFTER DILATION OF THE ANAL VERGE, ONE PURSE-STRING WITH PROLENE 2¿0 (ETHICON, SOMERVILLE, NY, USA) WAS PREPARED 2.0 CM ABOVE THE HAEMORRHOIDAL APEX. THE HAEMOSTASIS WAS ACCURATELY CONTROLLED, OCCASIONALLY USING SUPPLEMENTARY HAEMOSTATIC SUTURES OF THE ANASTOMOTIC RING WITH 1¿2 STITCHES OF VICRYL 3¿0 (ETHICON, SOMERVILLE, NY, USA). IN STARR GROUP, TWO PPH-01 KITS (ETHICON-ENDOSURGERY, POMEZIA, ITALY) WERE USED. THE ANOSCOPE (PSA 33) WAS INTRODUCED INTO THE CAD 33 AND THREE HALF (180 ) PURSE-STRINGS WITH PROLENE 2¿0 (ETHICON, SOMERVILLE, NJ, USA), INCLUDING PROLAPSED RECTAL WALL WITH MUCOSA, SUBMUCOSA AND RECTAL MUSCLE WALL, WERE INSERTED ABOVE THE HAEMORRHOIDAL APEX, 1¿2 CM APART, TO INCLUDE THE TOP OF RECTOCELE OR PROLAPSE. THE ANTERIOR STAPLED LINE WAS RENFORCED USING 2¿3 VICRYL 3¿0 SUTURES (ETHICON) AND INSPECTED FOR BLEEDING. THE PROCEDURE WAS THEN REPEATED ON THE POSTERIOR RECTAL WALL. PAIN WAS OBSERVED FROM POSTOPERATIVE DAY 1 TO 7. PAIN WAS SIGNIFICANTLY HIGHER AFTER STAPL, PARTICULARLY FROM THE THIRD POSTOPERATIVE DAY,PROBABLY IN RELATION TO THE PERINEA WOUND. NO PATIENT OF EITHER GROUP EXCEEDED THE DOSE OF 1,000 MG/DAY OF PARACETAMOL-CODEIN AND THERE WAS A TREND OF MORE ANALGESIC ASSUMPTION IN PATIENTS OF STAPL GROUP (890±100 MG/DAY VS. 730±110 IN STARR GROUP). EARLY COMPLICATIONS INCLUDED BLEEDING (N=1 STARR GROUP) REQUIRING REOPERATION, AND DELAYED HEALING OF THE PERINEAL WOUND (N=10 STAPL GROUP). IN STAPL GROUP LATE COMPLICATIONS INCLUDED URGE TO DEFECATE (N=1), INCONTINENCE TO FLATUS (N=1), STENOSIS (N=1) TREATED BY RADIAL INCISION, AND DYSPAREUNIA (N=1), WHILE STARR GROUP INCLUDED URGE TO DEFECATE (N=4), INCONTINENCE TO FLATUS (N=2), STENOSIS (N=1), TREATED BY ENDOSCOPIC DILATATION. ALL PATIENTS WITH URGE TO DEFECATE AND INCONTINENCE TO FLATUS IMPROVED WITHIN 6 MONTHS AFTER THE OPERATION. IN DEFECOGRAPHY, SEVEN PATIENTS OF STAPL GROUP HAD A SMALL ANTERIOR ASYMPTOMATIC DIVERTICULUM THAT LOOKED LIKE A SMALL RESIDUAL MARTI¿S TYPE RECTOCELE. EVEN THOUGH A LONGER FOLLOW-UP IN A HIGHER NUMBER OF OPERATED PATIENTS IS NECESSARY, BOTH STAPL AND STARR ARE SAFE AND EFFECTIVE IN OOS, DUE TO A COMBINATION OF RECTAL INTUSSUSCEPTION AND RECTOCELE: POSTOPERATIVE PAIN IS MINIMAL, OPERATING TIME AND HOSPITAL STAY ARE SHORT, TIME TO RETURN TO WORK IS FAST AND OVERALL PATIENT SATISFACTION IS HIGH. THE CONSTIPATION SCORE SIGNIFICANTLY IMPROVES, WHILE THE USE OF THE ANAL DILATOR AND THE RESECTION OF RECTAL WALL DO NOT CAUSE PERSISTENT ALTERATIONS OF THE ANAL INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567807 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention