BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 12617398 · Received October 12, 2021

    Report

    Report Number
    2210968-2021-09566
    Event Type
    Injury
    Date Received
    October 12, 2021
    Date of Event
    January 1, 2021
    Report Date
    September 17, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS, DEMOGRAPHICS REGARDING THE ADDITIONAL EVENTS. ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE AUTHOR/SURGEON BELIEVE THAT ETHICON PRODUCTS (VICRYL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO POST-OP COMPLICATIONS (WOUND INFECTION GRADE 3A, WITH PROLONG HOSPITALIZATION, URINARY INFECTIONS (GRADE 1) AND TRANSIENT PAIN OF THE GENITOFEMORAL NERVE AREA) DESCRIBED IN THE ARTICLE? PLEASE SPECIFY. DOES THE AUTHOR/SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (VICRYL SUTURE) USED IN THIS STUDY? IF YES, PLEASE PROVIDE PATIENT DEMOGRAPHICS FOR THE PATIENTS THAT EXPERIENCED THE POST-OPERATIVE COMPLICATIONS (WOUND INFECTION GRADE 3A, WITH PROLONG HOSPITALIZATION, URINARY INFECTIONS (GRADE 1) AND TRANSIENT PAIN OF THE GENITOFEMORAL NERVE AREA)? WERE ALL THESE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. CITATION: TRANSL ANDROL UROL 2021;10(1):56-65 / HTTP://DX.DOI.ORG/10.21037/TAU-20-789.

    Description of Event or Problem · 0

    TITLE: EXPERIENCE MANAGING DISTAL URETERAL STRICTURES WITH BOARI FLAPPSOAS HITCH AND COMPARISON OF OPEN AND LAPAROSCOPIC PROCEDURES. THIS STUDY AIMS TO DESCRIBE THE AUTHORS EXPERIENCE WITH THE BOARI FLAP-PSOAS HITCH, FROM SURGICAL INDICATIONS TO TECHNIQUE CONSIDERATIONS. BETWEEN JANUARY 2015 AND APRIL 2019, 35 PATIENTS (26 FEMALES AND 9 MALES) WITH MEDIAN AGE OF 46.0 YEARS (RANGE, 20¿71 YEARS) RECEIVED A MODIFIED BOARI FLAP-PSOAS HITCH BY THE SAME SURGEON (DR. LI XS).NINETEEN PATIENTS UNDERWENT OPEN SURGERY, AND 16 PATIENTS UNDERWENT LAPAROSCOPIC SURGERY. THE MEDIAN AGE OF PATIENTS IN THE LAPAROSCOPIC GROUP WAS 32.0 YEARS (RANGE, 20¿60 YEARS), WHILE THE MEDIAN AGE OF PATIENTS IN THE OPEN GROUP WAS 49.0 YEARS (RANGE, 25¿71 YEARS). FOR ETIOLOGY OF IATROGENIC INJURY AND URETEROVESICAL REIMPLANTATION FAILURE CAUSED 20 CASES OF URETERIC STRICTURES. AMONG THESE PATIENTS, TWELVE (4 MALES AND 8 FEMALES) MEDIAN AGE 36 [20¿60 YEARS] UNDERWENT LAPAROSCOPIC SURGERY, AND EIGHT (3 MALES AND 5 FEMALES) WITH MEDIAN AGE 48.5 [36¿60 YEARS] UNDERWENT OPEN SURGERY. DURING BOTH OPEN AND LAPAROSCOPIC PROCEDURES, THE ANTERIOR BLADDER WALL WAS OPENED WITH A 4-CM TRANSVERSE DISSECTION. THEN, THE URETER WAS CUT OFF AT THE END OF THE HEALTHY REGION, AND THE DISTAL STUMP URETER WAS LIGATED. THE URETER WAS CUT LONGITUDINALLY FOR APPROXIMATELY 1.5¿2.0 CM FOR ANASTOMOSIS. THE FULL THICKNESS OF THE BLADDER WALL WAS FIXED TO THE IPSILATERAL INTERIOR PSOAS MUSCLE BY THREE INTERRUPTED 2-0 VICRYL SUTURES. THE APEX OF THE FLAP MUCOSAL INCISION WAS SUTURED TO THE SPATULATED URETER BY INTERRUPTED 4-0 VICRYL SUTURES AND THE FLAP EDGES WERE SUTURED ALONG THE URETER EDGE WITH INTERRUPTED 4-0 VICRYL SUTURES. A 7-FR DOUBLE J URETERAL STENT WAS THEN INSERTED IN THE RENAL PELVIS ACROSS THE ANASTOMOSIS. FINALLY, THE FLAP WAS TUBULARIZED BY RUNNING 3-0 BARBED SUTURES, AND WAS REINFORCED BY INTERRUPTED 4-0 VICRYL SUTURES WHEN NECESSARY . POSTOPERATIVE FOLLOW-UP WAS CARRIED OUT AT THE CLINIC 3 AND 6 MONTHS AFTER SURGERY. REPORTED COMPLICATIONS INCLUDED: 7 PATIENTS IN THE OPEN SURGERY GROUP SUFFERED FROM SURGICAL COMPLICATIONS: (N=2) EXPERIENCED PARTIAL ILEUS (GRADE 2), (N=1) DEVELOPED A WOUND INFECTION (GRADE 3A) PATIENTS WHO DEVELOPED A WOUND INFECTION STAYED IN THE HOSPITAL FOR APPROXIMATELY 46 DAYS AND ULTIMATELY RECOVERED FOLLOWING WOUND DEBRIDEMENT SURGERY, 2 DEVELOPED URINARY INFECTIONS (GRADE 1) AND 1 DEVELOPED TRANSIENT PAIN OF THE GENITOFEMORAL NERVE AREA (GRADE 1). FOR PATIENT WITH IATROGENIC INJURY ETIOLOGY: (N=3) SURGICAL COMPLICATIONS IN THE OPEN SURGERY GROUP. IT WAS CONCLUDED, THAT BOARI FLAP-PSOAS HITCH IS AVAILABLE FOR BRIDGING COMPLEX DISTAL URETERAL DEFECTS IN BOTH OPEN AND LAPAROSCOPIC APPROACHES. THIS TECHNIQUE ACHIEVES A WATERTIGHT, TENSION-FREE ANATOMIC RECONSTRUCTION AND PRESERVES ADEQUATE VASCULAR PERFUSION. LAPAROSCOPIC SURGERY SHOWS THE ADVANTAGE OF MINIMALLY INVASIVE SURGERY WITH FEWER SURGICAL COMPLICATIONS THAN OPEN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1514724 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R