BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARIS TRANSOBTURATOR SLING (COLOPLAST)

    MDR report key: 12381034 · Received August 27, 2021

    Report

    Report Number
    2125050-2021-01206
    Event Type
    Injury
    Date Received
    August 27, 2021
    Date of Event
    December 1, 2015
    Report Date
    October 29, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    OTN
    UDI-DI
    05708932442961
    PMA / PMN Number
    K050148
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE. NO TRENDS WERE NOTED FOR COMPLAINTS AND THERE WERE NO NONCONFORMING REPORTS OR CAPAS THAT WERE CONFIRMED TO BE ASSOCIATED. COLOPLAST ROUTINELY REVIEWS EVENTS SUCH AS THIS AND MONITORS COMPLAINT LEVELS. ADDITIONALLY, EVENTS OF THIS TYPE ARE CAPTURED IN THE PRODUCT RISK DOCUMENTATION. BASED ON THIS INFORMATION NO FURTHER CORRECTIVE ACTION IS REQUIRED AT THIS TIME. SHOULD ADDITIONAL INFORMATION PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED. B3: ESTIMATED DATE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION REPORTED TO COLOPLAST ON (B)(6)2024, THOUGH NOT VERIFIED: THE PATIENT WAS IMPLANTED WITH THE DEVICE ON (B)(6) 2015 WITH NO IMMEDIATE COMPLICATIONS. AT CLOSE FOLLOW-UP, RECURRENT INCONTINENCE AND URINARY TRACT INFECTIONS WERE NOTED. THE PATIENT WAS REFERRED TO A SPECIALIZED CENTER AND A PERSISTENT URETHRAL HYPERMOBILITY COUPLED WITH A PROBABLE NEUROGENIC BLADDER WAS OBSERVED. NO MENTION WAS MADE OF A PAIN PROBLEM AT THIS TIME, FROM (B)(6) 2018 TO (B)(6) 2019. IN PARALLEL, THE PATIENT WAS EVALUATED IN PHYSIATRY IN (B)(6) 2016, AND THE REPORT MENTIONS A CHRONIC PAIN PROBLEM (NECK/SHOULDERS/PELVIS/KNEES/KNEES) SINCE 2014, IN CONNECTION WITH FIBROMYALGIA. THE PATIENT CONSULTED ANOTHER PRIVATE CENTER (USA) IN (B)(6) 2020, AND THE SLING WAS RADICALLY REMOVED ON (B)(6) 2020. THIS WAS FOLLOWED BY PERINEAL RECONSTRUCTION WITH A BIOLOGICAL SLING AND COLPOSACROPEXY ON (B)(6) 2022, AND A FURTHER INTERVENTION TO CUT THE SUBURETHRAL SLING DUE TO OBSTRUCTION ON (B)(6), 2022. OVERALL, THERE WAS AN IMPROVEMENT IN LOCAL PAIN, BUT IT IS CLEARLY DIFFICULT TO ASSESS THE PROPORTION OF SYMPTOMS THAT COULD BE ATTRIBUTED TO THE INITIAL TRANS-OBTURATOR-IITAL STRIP, GIVEN THE COMPLEXITY OF THE PRESENTATION AND THE VARIOUS MEDICAL HISTORIES.

    Additional Manufacturer Narrative · 1

    COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT.

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, BETWEEN 12/14/2015-1/11/2020: 3 WEEKS POST-OP. BURNING URINATION, WHITE DISCHARGE AND FOUL ODOR. TYPICAL HSV LESIONS PRESENT. CYSTITIS, HSV. CULTURES TAKEN WITH E COLI. CYSTITIS FOR 2-3 WEEKS, FREQUENT URINATION IN DAYTIME. RELAPSED IUE, REPEATED CYSTITIS, VULVAR LESIONS. URGE INCONTINENCE HAS RELAPSED INTO PREVIOUS BEHAVIOR. WILL HAVE BOTOX PERFORMED. UA POSITIVE FOR MUCUS AND LEUKOCYTES. CULTURE PERFORMED. PESSARY TRAINING. URODYNAMICS PERFORMED. C/O VULVAR HSV AND PAIN. MIXED URINARY INCONTINENCE. URODYNAMICS PERFORMED, HYPERMOBILITY NOTED. C/O MIXED INCONTINENCE PREVENTING HER FROM ACTIVITIES OF DAILY LIVING. CYSTOSCOPY PERFORMED, REVEALING GRADE II CYSTOCELE, DECREASED TONE, IUE, HYPERMOBILITY, AND MARSHALL. PELVIC ULTRASOUND PERFORMED. MIXED INCONTINENCE, DAILY URGENCY, NOCTURIA 1-2X¿S. CYSTOSCOPY WITH IUE AND GRADE II CYSTOCELE. WILL RECEIVE BOTOX. MIXED URINARY INCONTINENCE, HYPERMOBILITY. BOTOX SUGGESTED IN THE AREA OF THE DISPLACED SLING. ABSCESS ON VULVA, SURGICALLY REMOVED. DYSPAREUNIA, BILATERAL GROIN PAIN, HIP AND VAGINAL PAIN AS WELL AS COCCYX PAIN. LEAKAGE WITH LAUGH/COUGH/ SNEEZE WITH URGENCY. INTERMITTENT DYSURIA. VAGINA- PAIN FULL CORDS R>L, PAIN AT OIM L>R. 1/11/2020: REMOVAL OF ARIS TOT SLING, REMOVAL OF VULVAR MESH WITH EXPLORATION OF THE OBTURATOR SPACE, URETHRAL LYSIS, VAGINAL PARAVAGINAL, DISSECTION AND MESH REMOVAL FROM THE DEEP OBTURATOR INTERNUS MUSCLES, AND ANTERIOR COLPORRHAPHY UNDER GENERAL ANESTHESIA FOR COMPLAINTS OF VAGINAL PAIN, DYSPAREUNIA, MUSCULAR GROIN PAIN, LEG PAIN, FOREIGN MATERIAL IN VAGINA AND URETHRAL SCARRING. PER OP REPORT- THIS WAS A VERY DIFFICULTY SURGERY DUE TO SCARRING FROM PREVIOUS SURGERY AND THE DISSECTION REQUIRED TO REMOVE THE MESH FROM THE RIGHT GROIN THAT WAS VERY DEEPLY IMPLANTED AS WELL AS THE DEPTH OF PLACEMENT IN THE BLADDER NECK TISSUES AND THE SLING LOCATED AT THE BLADDER NECK. PATHOLOGY- FINAL DIAGNOSIS: VAGINA, ARIS MESH, EXCISION: FIBROUS TISSUE AND SKELETAL MUSCLE WITH GIANT CELL REACTION TO FOREIGN MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1277456 ARIS TRANSOBTURATOR SLING (COLOPLAST) SURGICAL MESH OTN COLOPLAST A/S 5195512400 AP030021_5195102400 05708932442961

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Required Intervention