BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 18833408 · Received March 4, 2024

    Report

    Report Number
    2210968-2024-02339
    Event Type
    Injury
    Date Received
    March 4, 2024
    Date of Event
    October 12, 2022
    Report Date
    March 4, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS REPORTED VIA 2210968-2024-02338 AND 2210968-2024-02339. CITATION: TRANSPL INT 35:10731. HTTPS://DOI.ORG/10.3389/TI.2022.10731.

    Description of Event or Problem · 0

    TITLE: DONOR SIZE DOESN¿T IMPACT EN BLOC KIDNEY TRANSPLANT OUTCOMES: A SINGLE-CENTER EXPERIENCE AND REVIEW OF LITERATURE. THE PURPOSE OF THIS STUDY WAS TO INVESTIGATE THE NON-INFERIORITY OF PEDIATRIC EN BLOC KIDNEYS FROM DONORS WITH BW<10 KG. BETWEEN 2003 AND 2021, 46 ADULT RECIPIENTS (23 MALES, 23 FEMALES, MEAN AGE OF 47.43 ± 14.63 YEARS) OF EN BLOC KIDNEY TRANSPLANTS FROM PEDIATRIC DONORS WERE INCLUDED IN THE STUDY. PEDIATRIC DONORS WERE STRATIFIED INTO 2 GROUPS ACCORDING TO DONOR BODY WEIGHT: (SMALL GROUP, DONOR BODY WEIGHT <10 KG, N = 30; STANDARD GROUP, DONOR BODY WEIGHT <10 KG, N = 16). DURING BACKBENCH PREPARATION OF THE GRAFT, THE PROXIMAL STUMP OF THE INFERIOR VENA CAVA AND THE AORTA ARE OVERSEWN WITH 6.0 PROLENE SUTURE (ETHICON). THE DISTAL ENDS OF THE INFERIOR VENA CAVA AND THE AORTA ARE USED FOR THE ANASTOMOSES. ALL AORTA AND INFERIOR VENA CAVA LUMBARS AS WELL AS ADRENAL AND GONADAL VESSELS ARE SECURED WITH NON-ETHICON 4/0 SILK TIES (MANUFACTURER: UNKNOWN). THEN, THE GRAFT IS FLIPPED 180° IN ORDER TO ALIGN THE AORTA AND INFERIOR VENA CAVA WITH RECIPIENT EXTERNAL ILIAC ARTERY AND VEIN RESPECTIVELY. END-TO-SIDE ARTERIAL ANASTOMOSIS BETWEEN THE DISTAL AORTA OF THE GRAFT AND THE EXTERNAL ILIAC ARTERY ARE PERFORMED WITH 6.0 PROLENE SUTURE (ETHICON). THE VENOUS ANASTOMOSIS IS AN END-TO-SIDE ANASTOMOSIS BETWEEN THE DISTAL INFERIOR VENA CAVA OF THE GRAFT AND THE EXTERNAL ILIAC VEIN OF THE RECIPIENTS SUTURED WITH 6.0 PROLENE SUTURE (ETHICON). 2 SEPARATED URETERONEOCYSTOSTOMY ANASTOMOSES OVER DOUBLE-J STENTS ARE ROUTINELY PERFORMED AND SUTURED WITH 5.0 PDS SUTURE (ETHICON). INDUCTION THERAPY CONSISTS OF RABBIT ANTITHYMOCYTE GLOBULIN AND METHYLPREDNISOLONE FOLLOWED BY A RAPID, 5-DAY STEROID TAPER. MAINTENANCE WAS ACHIEVED USING MYCOPHENOLATE AND TACROLIMUS (8¿12 NG/ML FOR THE FIRST 2 MONTHS, THEN 5¿10 NG/ML THEREAFTER). INSTITUTIONAL IMMUNOSUPPRESSION REGIMEN DID NOT CHANGE DURING THE STUDY PERIOD. REPORTED COMPLICATIONS INCLUDED PERINEPHRIC HEMATOMA (N=7), ARTERIAL THROMBOSIS IN POSTOPERATIVE DAY 1 LEADING TO GRAFT LOSS (N=1), URINARY LEAKAGE FROM ONE OF THE 2 REIMPLANTED URETERS (N=2), AND POSTOPERATIVE STRICTURE OF THE REIMPLANTED URETER, WHICH COMPLICATED WITH HYDRONEPHROSIS AND MULTIPLE URINARY TRACT INFECTIONS (N=1). IN CONCLUSION, GRAFT AND PATIENT SURVIVAL RATES AFTER EN BLOC KIDNEY TRANSPLANTATION FROM DONORS WITH BODY WEIGHT <10 KG ARE NOT DIFFERENT FROM HEAVIER DONORS. RENAL FUNCTION IS UNAFFECTED BY DIFFERENCES IN DONOR BODY WEIGHT. THE DONOR BODY WEIGHT <10 KG GROUP IS AT AN INCREASED RISK FOR SURGICAL COMPLICATIONS IN EARLY POST-TRANSPLANT PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1519488 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention