BEUDAMED
    FDA Adverse Event Death Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 14945031 · Received July 7, 2022

    Report

    Report Number
    2210968-2022-05177
    Event Type
    Death
    Date Received
    July 7, 2022
    Date of Event
    January 1, 2020
    Report Date
    July 7, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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. PLEASE PROVIDE SPECIFIC NUMBER OF PATIENTS WITH THE FOLLOWING EVENTS: NON-REVERSAL OF HINDBRAIN HERNIATION, CSF LEAKAGE AT BIRTH, UNDERWENT POSTNATAL REVISION OF REPAIR, TREATED FOR HYDROCEPHALUS, UNDERWENT SURGERY FOR TETHERED CORD, FOR SHUNT PLACEMENT OR DIED BEFORE 12 MONTHS OF AGE, AS THE SLC COHORT USES OTHER MANUFACTURERS DEVICE FOR PRIMARY CLOSURE. PLEASE PROVIDE SPECIFIC NUMBER OF PATIENTS FOR SHUNT PLACEMENT THAT DIED, AS RESULTS WERE ALSO COMBINED. PLEASE CLARIFY WHAT CAUSES THE DEATH OF THESE PATIENTS. EXPLANATION FOR TABLE 3 WAS "COMPOSITE OF DEATH BEFORE PLACEMENT OF SHUNT AND/OR MET MANAGEMENT OF MYELOMENINGOCELE STUDY (MOMS) CRITERIA4 FOR SHUNT PLACEMENT UP TO 1 YEAR OF AGE". DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS (VICRYL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS/DEATH DESCRIBED IN THE ARTICLE? 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? HAS AN AUTOPSY BEEN PERFORMED FOR DEATH CASE? IF SO, CAN THE RESULTS BE SHARED? WOULD THE JOURNAL AUTHOR / PHYSICIAN LIKE TO SPEAK WITH ETHICON MEDICAL SAFETY AND ENGINEERING VIA SCHEDULED CONFERENCE CALL REGARDING THE PRODUCT INVOLVED IN THIS EVENT? 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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2022-05176. CITATION: ULTRASOUND OBSTET GYNECOL 2020; 56: 532¿540. DOI: 10.1002/UOG.21915.

    Description of Event or Problem · 0

    TITLE: COMPARISON OF TWO FETOSCOPIC OPEN NEURAL TUBE DEFECT REPAIR TECHNIQUES: SINGLE- VS THREE-LAYER CLOSURE. THE AIMS OF THIS RETROSPECTIVE STUDY OF PROSPECTIVELY COLLECTED DATA WERE TO COMPARE SLC AND 3LC IN TERMS OF INTRAOPERATIVE, POSTOPERATIVE AND OBSTETRIC OUTCOMES, AS WELL AS SHORT-TERM NEONATAL NEUROLOGIC AND NON-NEUROLOGIC OUTCOMES. BETWEEN APRIL 2014 AND DECEMBER 2018, 58 PATIENTS WERE SCHEDULED FOR OPEN NEURAL TUBE DEFECT (ONTD) REPAIR, BUT 8 WERE EXCLUDED. A TOTAL OF 50 PATIENTS WERE INCLUDED IN THE STUDY AND UNDERWENT EXTERIORIZED-UTERUS TWO-PORT FETOSCOPIC REPAIR OF OPEN NEURAL TUBE DEFECT (ONTD) USING 2 METHODS. SINGLE-LAYER CLOSURE (SLC) TECHNIQUE WAS PERFORMED BETWEEN 2014 AND 2017 IN 32 PATIENTS (SLC CONTROLS; MATERNAL AGE WAS 28.3±5.6 YEARS; MEAN GESTATIONAL AGE (GA) AT FETAL SURGERY WAS 25.0±0.7 WEEKS) AND PRIMARY CLOSURE WAS ACHIEVED WITH A SINGLE UNIFIED LAYER OF SKIN AND DURA USING INTERRUPTED (POLYGLACTIN 3/0 (ETHICON INC., (B)(4) USA), POLY-4-HYDROXYBUTYRATE (AESCULAP INC., CENTER VALLEY, PA, USA)) OR RUNNING (4/0 BARBED SUTURE (V-LOC¿; COVIDIEN, (B)(4) USA)) VERTICAL MATTRESS STITCHES. IN 2017, THE PROTOCOL WAS CHANGED TO A THREE-LAYER CLOSURE (3LC) TECHNIQUE USED IN 18 PATIENTS (3LC CONTROLS; MATERNAL AGE WAS 29.7±6.4 YEARS; MEAN GESTATIONAL AGE (GA) AT FETAL SURGERY WAS 25.0±0.5 WEEKS). FOLLOWING DISSECTION OF THE PLACODE, BILATERAL DURAFASCIAL OR MYOFASCIAL FLAPS (DEPENDING ON THE AMOUNT OF AVAILABLE MUSCLE) WERE CUT USING A COLORADO MICRODISSECTION NEEDLE (STRYKER) SET TO 10W POWER. THESE MUSCLE FLAPS WERE CUT PARALLEL TO THE SPINAL DEFECT, AND THEN, IF POSSIBLE, UNDERMINED TO INCREASE THE SIZE OF THE FLAP. A BOVINE COLLAGEN PATCH (DUREPAIR, MEDTRONIC, GOLETA, CA, USA), PREVIOUSLY CUT AND SHAPED BASED ON MEASUREMENTS OBTAINED FROM MRI, WAS THEN DELIVERED VIA ONE OF THE 12-FR PORTS, USING THE NEEDLE DRIVER, AND PLACED DIRECTLY OVER THE PLACODE. NO SUTURES WERE USED TO HOLD IT IN PLACE. THE DURAFASCIAL FLAPS WERE THEN SUTURED OVER THE PATCH IN THE MIDLINE USING INTERRUPTED POLYGLACTIN SUTURES (VICRYL®; ETHICON INC.). THE SKIN WAS THEN CLOSED OVER THE FLAPS USING INTERRUPTED POLY-4-HYDROXYBUTYRATE SUTURES. IN ALL 3LC CASES, WE USED A STRAIGHTENED NEEDLE, WITH SLIDING KNOTS TIED EXTRACORPOREALLY AND THEN POSITIONED WITH A KNOT PUSHER (KARL STORZ (B)(4)). REPORTED COMPLICATIONS INCLUDE NON-REVERSAL OF HINDBRAIN HERNIATION (N=?), CSF LEAKAGE AT BIRTH (N=?), UNDERWENT POSTNATAL REVISION OF REPAIR (N=?), TREATED FOR HYDROCEPHALUS (N=?), UNDERWENT SURGERY FOR TETHERED CORD (N=?), AND FOR SHUNT PLACEMENT OR DIED BEFORE 12MONTHS OF AGE (N=?). IN CONCLUSION, WHILE IT SHOULD BE REMEMBERED THAT THE USE OF A MULTILAYER CLOSURE IS A TECHNICAL ADVANCE, AND THAT THE TRANSLATION INTO IMPROVED NEUROLOGIC OUTCOME IS YET TO BE SHOWN, THESE DATA ARE ENCOURAGING. WE BELIEVE THAT THE EXTERIORIZED-UTERUS TWO-PORT FETOSCOPIC TECHNIQUE AND A THREE-LAYER FETAL ONTD CLOSURE ARE REASONABLE PLATFORMS FROM WHICH TO FURTHER INNOVATE IN THE QUEST FOR A PERCUTANEOUS APPROACH THAT DELIVERS OPTIMAL MATERNAL, FETAL AND NEONATAL BENEFITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2672336 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| D