BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 19114522 · Received April 16, 2024

    Report

    Report Number
    2210968-2024-04346
    Event Type
    Injury
    Date Received
    April 16, 2024
    Date of Event
    November 15, 2023
    Report Date
    April 16, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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. CITATION: JOURNAL OF PLASTIC, RECONSTRUCTIVE & AESTHETIC SURGERY 88 (2024) 397¿406; HTTPS://DOI.ORG/10.1016/J.BJPS.2023.11.021.

    Description of Event or Problem · 0

    TITLE: PHARYNGEAL FLAP OUTCOMES FOR VELOPHARYNGEAL INSUFFICIENCY: EVALUATION OF SPEECH, OBSTRUCTIVE SLEEP APNEA, AND VELOPHARYNGEAL ANATOMY. THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE SPEECH OUTCOMES, REVEAL POSTOPERATIVE RATES OF OBSTRUCTIVE SLEEP APNEA, AND CHARACTERIZE CHANGES IN THE PHARYNGEAL FLAP AND VELOPHARYNGEAL ANATOMY FOLLOWING PHARYNGEAL FLAP SURGERY FOR VELOPHARYNGEAL INSUFFICIENCY. BETWEEN NOVEMBER 2020 AND NOVEMBER 2021, 72 NONSYNDROMIC PATIENTS WHO UNDERWENT PHARYNGEAL FLAP SURGERY FOLLOWING CLEFT PALATE REPAIR WERE INCLUDED IN THE STUDY. THERE WERE 39 MALES AND 33 FEMALES WITH A MEAN AGE OF 10.6 ± 6.2 YEARS. DURING THE PROCEDURE, THE SOFT PALATE WAS SPLIT IN THE MIDLINE FROM THE UVULA APPROXIMATELY HALFWAY TO THE HARD PALATAL JUNCTION, AND THE PALATAL MUSCLE WAS DISSECTED OFF THE NASAL LAYER. A TRIANGULAR MUCOSAL FLAP WAS HARVESTED FROM THE NASAL SIDE OF THE SOFT PALATE AND PREPARED FOR TRANSPOSING IN A BACK-FLIP FASHION TO COVER THE RAW SURFACE OF THE PHARYNGEAL FLAP. THE PENTAGON-SHAPED PHARYNGEAL FLAP WAS INCISED AND ELEVATED OFF THE PRE-FASCIAL AREOLAR PLANE AND APPOSED TO THE NASAL SIDE OF THE SOFT PALATE AT THE ANTERIOR MARGIN USING 4-0 VICRYL (ETHICON) SUTURES. THE NASAL MUCOSAL FLAPS WERE SUTURED TO THE BASE OF THE PHARYNGEAL FLAP USING 4-0 VICRYL (ETHICON) SUTURES AND PLACED TO COVER THE RAW SURFACE OF THE PHARYNGEAL FLAP. THE PHARYNGEAL DONOR SITE WAS REPAIRED VIA MEDIAL ADVANCEMENT OF THE LATERAL MUCOSAL WALLS USING A 3-0 VICRYL (ETHICCON) SUTURE. THE PALATE MUSCLE MASS WAS REPAIRED IN THE POSTERIOR HALF OR ONE-THIRD OF THE VELUM WITH A 4-0 VICRYL (ETHICON) SUTURE. THE MIDLINE ORAL MUCOSA WAS REPAIRED USING 5-0 VICRYL (ETHICON) SUTURES. REPORTED COMPLICATIONS INCLUDED TORTICOLLIS-LIKE NECK PAIN (N=1), DEHISCENCE OF THE ORAL MUCOSA (N=1), POSTOPERATIVE BLEEDING (N=2) AND OBSTRUCTIVE SLEEP APNEA (N=5) . IN CONCLUSION, THE PHARYNGEAL FLAP IMPROVED SPEECH OUTCOMES IN PATIENTS WITH VELOPHARYNGEAL INSUFFICIENCY WITH A RELATIVELY LOW INCIDENCE OF OBSTRUCTIVE SLEEP APNEA (6.9 PERCENT). THE VELUM IS POSITIONED MORE SUPERIORLY AND POSTERIORLY, AND THE SIZE OF THE VELOPHARYNGEAL GAP IS SUBSTANTIALLY REDUCED AFTER PHARYNGEAL FLAP SURGERY. IN ADDITION, THE PHARYNGEAL FLAP PARTIALLY ATROPHIED OVER TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1445865 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention