BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 20504342 · Received October 22, 2024

    Report

    Report Number
    2210968-2024-10886
    Event Type
    Injury
    Date Received
    October 22, 2024
    Date of Event
    October 11, 2023
    Report Date
    October 22, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: EUROPEAN ARCHIVES OF OTO-RHINO-LARYNGOLOGY (2024) 281:283¿294. HTTPS://DOI.ORG/10.1007/S00405-023-08263-8.

    Description of Event or Problem · 0

    TITLE: CONGENITAL LARYNGO-TRACHEO-ESOPHAGEAL CLEFTS: UPDATES FROM A QUATERNARY CARE PEDIATRIC AIRWAY UNIT. THE PURPOSE OF THIS STUDY IS TO REVIEW THE OPERATIVE TECHNIQUES, OUTCOMES, AND COMPLICATIONS FOLLOWING SURGERY IN PEDIATRIC PATIENTS WITH LARYNGO-TRACHEO-ESOPHAGEAL CLEFTS (LTEC). A TOTAL OF 25 PEDIATRIC PATIENTS (19 MALES AND 6 FEMALES) UNDERWENT SURGICAL REPAIR FOR LTEC FROM (B)(6) 2012 TO (B)(6) 2022. THE PATIENTS HAD MULTIPLE OTHER MALFORMATIONS, SPECIFCIALLY GASTRO-INTESTINAL, SYNCHRONOUS AIRWAY, AND CARDIAC. THE MEAN AGE AT FIRST SURGERY AT THE AUTHORS' CLINIC WAS 2 YEARS AND 20 DAYS OLD (RANGE FROM 30 DAYS TO 10.2 YEARS). THE CLEFT DISTRIBUTION ACCORDING TO THE MODIFIED BENJAMIN AND INGLIS CLASSIFICATION WAS TYPE I (N=5, 20%), TYPE II (N=6, 24%), TYPE IIIA (N=8, 32%), TYPE IIIB (N=4, 16%), AND TYPE IVA (N=2, 8%). THE MEDIAN FOLLOW-UP WAS 44.6 MONTHS. FOR ENDOSCOPIC APPROACH, A 5.0 VICRYL (TF-1 PLUS, ETHICON, REF. V133H NEEDLE SIZE 10 MM IN MOST CASES) OR 7.0 POLYDIOXANONE (ETHICON, PDS-II, NEEDLE SIZE 9.3 MM IN VERY SMALL INFANTS AND NEONATES, REF. Z1701E) TO SUTURE THE TWO MUCOSAL LAYERS, BEGINNING FROM THE CAUDAL END AND PROGRESSING UP TO THE CRANIAL END OF THE CLEFT. THE SUTURES IN BOTH THE MUCOSAL LAYERS WERE TIED TOWARD THE ESOPHAGEAL SIDE, AND THE SUTURES ON THE TRACHEA¿LARYNGEAL LAYER WERE CUT CLOSE TO THE KNOT. THE LARYNGOSCOPE WAS PROGRESSIVELY WITHDRAWN TO PLACE MORE CRANIAL SUTURES. FIBRIN GLUE (TISSEEL) WAS PLACED BETWEEN THE TWO MUCOSAL LAYERS JUST BEFORE TYING THE MOST CRANIAL SUTURE. DEPENDING ON THE CLEFT LENGTH, TOTAL OF 2 (TYPE I)¿20 (TYPES III AND IV) SUTURES WERE USED TO CLOSE THE CLEFT. FOR COMBINED APPROACH, THE OP MUCOSAL CLOSURE WAS MADE FROM CAUDAL TO CRANIAL ENDS OF THE CLEFT USING 5.0 VICRYL AND THE SUTURES ARE CUT TOWARD THE ESOPHAGEAL SIDE. A RIB CARTILAGE GRAFT WAS HARVESTED AND SCULPTED TO HAVE CRANIAL AND CAUDAL PERICHONDRIAL EXTENSIONS. THE CARTILAGE WAS FIXED TO REPLACE THE DEHISCENT POSTERIOR CRICOID PLATE, AND THE PERICHONDRIAL EXTENSIONS REMAINED INTERPOSED BETWEEN THE OP AND TL MUCOSAL LAYERS. THE TL LAYER WAS CLOSED WITH SEPARATE 5.0 VICRYL SUTURES KNOTTED TOWARD THE AIRWAY. A SMALL-FOR-AGE MONNIER¿S¿ LARYNGO-TRACHEAL LT-MOLD AVOIDING DECUBITUS ON THE CLEFT SUTURES WAS PLACED AND DOUBLY FIXED (IN THE SUPRAGLOTTIS AND TRACHEA) USING 3.0 PROLENE. THE LARYNGOFISSURE WAS CLOSED USING MULTIPLE INTERMITTENT 4/5.0 VICRYL SUTURES. REPORTED COMPLICATIONS INCLUDE PATIENT 21: 7 YEARS 0 MONTHS 14 DAYS OLD MALE (N=1). MINOR-MODERATE/PARTIAL BREAKDOWN OF THE REPAIR. TREATMENT: NEEDING 3 CORRECTION SURGERY IN CONCLUSION, LTEC ARE RARE MALFORMATIONS, AND THEIR MANAGEMENT NEEDS PRECISE DIAGNOSIS, APPROPRIATE SURGICAL PLANNING, AND EXECUTION, AND DEDICATED POST-OPERATIVE CARE. PRIMARY AND REVISION REPAIR OF LONG CLEFTS WITH TRACHEAL EXTENSION MAY REQUIRE A COMBINED APPROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1934592 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention