BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORELLE  Y

    MDR report key: 12761140 · Received November 7, 2021

    Report

    Report Number
    2125050-2021-01610
    Event Type
    Injury
    Date Received
    November 7, 2021
    Date of Event
    January 1, 2021
    Report Date
    October 12, 2021
    Manufacturer
    COLOPLAST A/S
    Product Code
    OTO
    PMA / PMN Number
    K112322
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE MEAN AGE OF WOMEN WAS 59 YEARS; THE MAJORITY OF THE WOMEN WERE WHITE. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL INFORMATION PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    JONES, K., ET AL., SHORT-TERM OUTCOMES OF VAGINAL HYSTERECTOMY AT THE TIME OF ROBOTIC SACROCOLPOPEXY. FEMALE PELVIC MEDICINE & RECONSTRUCTIVE SURGERY, 2021. 27(1): P. E223-E226. DOI: 10.1097/SPV.0000000000000898. ACCORDING TO THE AVAILABLE INFORMATION, OF A TOTAL OF 209 WOMEN WHO HAD UNDERGONE VAGINAL HYSTERECTOMY WITH ROBOTIC SACROCOLPOPEXY BETWEEN JULY 2012 AND JULY 2017, 37 WERE IMPLANTED WITH ANOTHER MANUFACTURER'S Y-MESH, WHILE THE REMAINING 165 PATIENTS (82%) HAD RESTORELLE Y-MESH PLACED. INTRAOPERATIVE COMPLICATIONS INCLUDED TWO BLADDER INJURIES, BOTH OCCURRING AT THE TIME OF RETROPUBIC SLING PLACEMENT. NO CASES REQUIRED CONVERSION TO LAPAROTOMY. IMMEDIATE POSTOPERATIVE COMPLICATIONS INCLUDED SYMPTOMATIC ANEMIA, REQUIRING BLOOD TRANSFUSION IN TWO PATIENTS. BOTH PATIENTS WERE STABLE AFTER TRANSFUSION OF RED BLOOD CELLS. ALL BLOOD LOSS WAS THOUGHT TO HAVE OCCURRED DURING SURGERY AS HEMOGLOBIN NORMALIZED AFTER TRANSFUSION. BOTH PATIENTS WERE DISCHARGED HOME AFTER TRANSFUSION WITHOUT FURTHER COMPLICATION. A THIRD PATIENT PRESENTED FOUR DAYS POST OP WITH A PELVIC HEMATOMA DURING BRIDGING FROM LOVENOX TO COUMADIN. AT THE MEAN FOLLOW-UP TIME OF 49 WEEKS, PELVIC ORGAN PROLAPSE QUANTIFICATION REVEALED 20 PATIENTS WITH A OR BP GREATER OR EQUAL TO ZERO, AND 1.4% OF PATIENTS REQUIRED REPEAT PROLAPSE SURGERY. AMONG NINE WOMEN WITH POSTOPERATIVE FEVER, FOUR WERE TREATED FOR PELVIC COLLECTION/ABSCESS. ONE PATIENT REQUIRED IMAGE-GUIDED PERCUTANEOUS DRAINAGE AND ANTIBIOTIC THERAPY. THE SECOND PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS EXCLUSIVELY, AND A FOLLOW-UP COMPUTED TOMOGRAPHY SCAN SHOWED RESOLUTION. THE THIRD PATIENT REQUIRED EXPLORATORY LAPAROTOMY FOR SEPTIC SHOCK WHERE AN INFECTED HEMATOMA WAS DISCOVERED AND EVACUATED. BECAUSE OF CONCERN FOR INFECTED MESH, IT WAS REMOVED. THE EXPLANTED MESH GREW ESCHERICHIA COLI. MESH WAS REMOVED ROBOTICALLY IN THE FOURTH PATIENT WHO WAS SEPTIC FROM EPIDURAL ABSCESS. THIS PATIENT WAS IMMUNOCOMPROMISED; BECAUSE OF HIGH-DOSE STEROIDS, SHE REQUIRED A RHEUMATOID ARTHRITIS FLAIR. MICROBIOLOGY FROM THE INFECTED MESH CONFIRMED ENTEROCOCCUS FAECALIS. OF FIVE WOMEN WHO HAD VENOUS THROMBOEMBOLISM, THREE WERE DIAGNOSED WITH PULMONARY EMBOLISM. ONE OF THESE PATIENTS HAD NEW ONSET ATRIAL FIBRILLATION. THERE WERE 18 PATIENTS TREATED FOR URINARY TRACT INFECTION WITHIN SIX POSTOPERATIVE WEEKS. MESH EXPOSURE WAS NOTED IN 16 PATIENTS, AND 11 REQUIRED REOPERATION. MESH EXPOSURE WAS IDENTIFIED BETWEEN 2 WEEKS TO 3 YEARS POSTOPERATIVELY, WITH A MEAN TIME TO OCCURRENCE OF 48 WEEKS. THE MAJORITY OF THESE PATIENTS WERE SYMPTOMATIC, WITH COMPLAINTS OF BLEEDING AND INCREASED DISCHARGE. OF 16 MESH EXPOSURE CASES, 12 EXPOSURES WERE ASSOCIATED WITH GORE-TEX SUTURE. TWO CASES OF ILEUS WERE ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1659545 RESTORELLE  Y SURGICAL MESH OTO COLOPLAST A/S 5014202400

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention