BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 9397266 · Received December 2, 2019

    Report

    Report Number
    2210968-2019-90383
    Event Type
    Injury
    Date Received
    December 2, 2019
    Report Date
    November 11, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. WAS THE CASE OF THE (B)(6) FEMALE THAT EXPERIENCED URINOMA DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT (VICRYL 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 PRODUCT (VICRYL SUTURE) USED IN THIS PROCEDURE? CITATION: INVESTING CLIN UROL 2019;60:210-215; HTTPS://DOI.ORG/10.4111/ICU.2019.60.3.210. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: LAPAROSCOPIC TRANSPERITONEAL HEMINEPHRECTOMY FOR TREATMENT OF THE NONFUNCTIONING MOIETY OF DUPLEX KIDNEY IN ADULTS: A CASE SERIES" AUTHORS: MANMEET SINGH, SAMARTH AGARWAL, APUL GOEL, MANOJ KUMAR, ASHISH SHARMA, SIDDHARTH PANDEY, SATYNARAYAN SANKHWAR. CITATION: INVESTIG CLIN UROL 2019;60:210-215; HTTPS://DOI.ORG/10.4111/ICU.2019.60.3.210. THE AIM OF THIS RETROSPECTIVE STUDY IS TO REPORT THE RESULTS AND EXPERIENCE OF A TERTIARY CARE CENTER IN LAPAROSCOPIC TRANSPERITONEAL HEMINEPHRECTOMY FOR THE TREATMENT OF A NON-FUNCTIONING UPPER POLE MOIETY OF DUPLEX KIDNEY IN ADULTS. BETWEEN 2010 AND 2015, A TOTAL OF 17 PATIENTS (N=7 MALES N=10 FEMALES, MEAN AGE: 32 YEARS, RANGE: 19-44 YEARS, MEAN BMI: 28 KG/M2) WERE INCLUDED IN THE STUDY. THE HARMONIC SCALPEL (ETHICON) SEPARATED THE UPPER POLE FROM THE REST OF THE RENAL PARENCHYMA. TWO PATIENTS HAD AN OPENING OF THE CALYCES THAT WAS SUTURED INTRAOPERATIVELY WITH VICRYL 3-0 (ETHICON). COMPLAINTS INCLUDED A PATIENT (N= (B)(6) MALE) HAD CLAVIEN-DINDO GRADE 3 COMPLICATION SHOWING CONTINUOUS EXTENSIVE DRAINAGE FOR 5 DAYS IN THE POSTOPERATIVE PERIOD. ON THE 5TH POSTOPERATIVE DAY, RETROGRADE PYELOGRAPHY WAS PERFORMED, AND A LEAK WAS SEEN NEAR THE UPPER PART OF THE URETER THAT WAS THOUGHT TO BE DUE TO AN IATROGENIC INJURY SUSTAINED WHILE THE DISEASED URETER WAS BEING DISSECTED. CONSEQUENTLY, THE PATIENT WAS STENTED WITH A 5-FR DOUBLE J STENT, AFTER WHICH THE OUTPUT REDUCED DRAMATICALLY. THE OTHER PATIENT (N=(B)(6) FEMALE) ALSO DEVELOPED A CLAVIEN-DINDO GRADE 3 COMPLICATION. ALTHOUGH THIS PATIENT WAS DISCHARGED ON DAY 3, SHE WAS READMITTED ON DAY 7 WITH SUDDEN-ONSET, SEVERE FLANK PAIN. A CONTRAST-ENHANCED CT SCAN SHOWED THAT SHE HAD A URINOMA OF AROUND 300 ML IN VOLUME. IT WAS DRAINED PERCUTANEOUSLY WITH ULTRASOUND GUIDANCE UNDER LOCAL INFILTRATION. AFTER ASPIRATION, THE PATIENT¿S SYMPTOMS IMPROVED RAPIDLY WITHIN 24 HOURS AND SHE WAS COMPLETELY PAIN-FREE AFTER 48 HOURS. A REPEAT ULTRASOUND AFTER 48 HOURS SHOWED NO RESIDUAL COLLECTION IN THE PERINEPHRIC REGION AND SHE WAS DISCHARGED. IN CONCLUSION, LAPAROSCOPIC HEMINEPHRECTOMY IS PLAYING A CORNERSTONE ROLE IN THE TREATMENT OF THE NON-FUNCTIONING MOIETY OF DUPLEX KIDNEYS. THE PROCEDURE IS SAFE, EFFICIENT AND OFFERS THE TYPICAL PREOPERATIVE AND POSTOPERATIVE BENEFITS OF LAPAROSCOPIC SURGERY. THE RATE OF COMPLICATIONS IN ADULTS IS ACCEPTABLE AND IS SIMILAR TO THAT REPORTED IN PEDIATRIC PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1192551 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention