BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 9169820 · Received October 8, 2019

    Report

    Report Number
    2210968-2019-88492
    Event Type
    Injury
    Date Received
    October 8, 2019
    Report Date
    September 12, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. WERE CASES OF CHRONIC PELVIC PAIN REPORTED AS IT IS UNCLEAR IN THE ARTICLE IF THIS EVENT OCCURRED? IF YES, PLEASE SPECIFY THE NUMBER PER TREATMENT ARM AND IF THIS IS LIKELY RELATED TO ANY ETHICON DEVICE USE IN THE PROCEDURE (ULTRAPRO MESH; PDS SUTURE; PROLENE SUTURE)? PLEASE CONFIRM IF WHICH OF THE TWO SUTURES (2-0 PDS OR 2-0 PROLENE) IN SCP GROUP WAS UTILIZED ON PATIENTS EXPERIENCING VAGINAL BULGE SYMPTOMS, RECURRENT PROLAPSE AND MESH EXPOSURE? DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (PROLENE SUTURE, ULTRAPRO MESH AND PDS II SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS INVOLVED? CITATION: INTERNATIONAL UROGYNECOLOGY JOURNAL; DOI: HTTPS://DOI.ORG/10.1007/S00192-018-3687-2 PUBLISHED ONLINE: JUNE 30, 2018. NOTE: EVENTS REPORTED VIA MW 2210968-2019-88493, 2210968-2019-88494. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: RCT OF VAGINAL EXTRAPERITONEAL UTEROSACRAL LIGAMENT SUSPENSION (VEULS) WITH ANTERIOR MESH VERSUS SACROCOLPOPEXY: 4-YEAR OUTCOME" AUTHOR/S: LIN LI OW, YIK N. LIM, JOSEPH LEE, CHRISTINE MURRAY, ELIZABETH THOMAS, ALISON LEITCH, ANNA ROSAMILIA & PETER L. DWYER. CITATION: INTERNATIONAL UROGYNECOLOGY JOURNAL; DOI: HTTPS://DOI.ORG/10.1007/S00192-018-3687-2 PUBLISHED ONLINE: JUNE 30, 2018. THIS MULTI-CENTER RANDOMIZED TRIAL AIMED TO ASSESS THE SAFETY AND EFFICACY OF VAGINAL EXTRAPERITONEAL UTEROSACRAL LIGAMENT SUSPENSION (VEULS) WITH ANTERIOR OVERLAY MESH VERSUS SACROCOLPOPEXY (SCP) FOR POSTHYSTERECTOMY VAULT PROLAPSE. BETWEEN 2006 AND 2011, 82 FEMALE PATIENTS WITH POSTHYSTERECTOMY VAULT PROLAPSE STAGE >2 WERE RANDOMIZED TO EITHER VEULS (N=39; MEAN AGE OF 65.3 YEARS [SD OF 7.9 YEARS]; MEAN BMI OF 27.8 [SD OF 3.41]) OR SCP (N=43; MEAN AGE OF 66.5 YEARS [SD OF 7.4 YEARS]; MEAN BMI OF 27.3 [SD OF 5.0]). FOR PATIENTS UNDERGOING VEULS, TWO 0 PDS SUTURES WERE PLACED THROUGH EACH UTEROSACRAL LIGAMENT AND THEN THROUGH THE FULL THICKNESS OF THE VAGINAL EPITHELIUM AT THE APPROPRIATE LOCATION I THE VAGINAL APEX (SIMILAR WAS CARRIED OUT ON THE OTHER SIDE). 2-0 PDS SUTURE WAS USED IN MIDLINE FASCIAL ANTERIOR REPAIR, THEN A WRIST-WATCH-SHAPED GRAFT OF ULTRAPRO WAS FASHIONED AND PLACED. CAREFUL CLOSURE OF ONE OR TWO LAYERS OF THE VAGINAL EPITHELIAL IS PERFORMED WITH 2¿0 VICRYL SUTURE. FOR PATIENTS UNDERGOING SCP, ULTRAPRO MESH WAS FASHIONED INTO A Y-SHAPE AND 2¿0 PDS OR 2¿0 PROLENE SUTURES (ETHICON) WAS USED TO ANCHOR THE MESH TO THE VAGINA. INTRAOPERATIVE COMPLICATIONS INCLUDED ESTIMATED BLOOD LOSS OF >400 ML (N=1 VEULS GROUP; N=1 SCP GROUP) WAS REPORTED; NEITHER NEEDED RETURN TO THEATER OR BLOOD TRANSFUSION. AT 12 MONTHS FOLLOW-UP COMPLICATIONS INCLUDED BOTHERSOME VAGINAL BULGE SYMPTOMS (N=3 VEULS GROUP; N=2 SCP GROUP). IN VEULS GROUP, RECURRENT PROLAPSE (N=7) WAS IDENTIFIED AND TREATED WITH REPEAT SURGERY (N=3), PESSARY (N=1) AND PHYSIOTHERAPY (N=3). IN SCP GROUP, RECURRENT PROLAPSE (N=4) WAS IDENTIFIED AND TREATED WITH REPEAT SURGERY (N=3) AND PHYSIOTHERAPY (N=1). AT 4 YEARS, COMPLICATIONS INCLUDED MESH EXPOSURE (N=4 VEULS GROUP; N=4 SCP GROUP) WHICH WERE CONSERVATIVELY MANAGED WITH TOPICAL ESTROGEN. THE THREE PATIENTS IN SCP GROUP WHO HAD MESH EXPOSURE HAD SURGERY (SIMILAR PATIENTS WHO HAD RECURRENT PROLAPSE). COMPOSITE OUTCOME OF SUCCESS WAS BETTER FOR SCP AT 12 MONTHS, BUT SUBJECTIVE OUTCOMES FOR PROLAPSE AT ALL TIMEPOINTS OVER 4 YEARS FOR VEULS AND SCP WERE NOT SIGNIFICANTLY DIFFERENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960227 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention