BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 12602048 · Received October 9, 2021

    Report

    Report Number
    2210968-2021-09427
    Event Type
    Injury
    Date Received
    October 9, 2021
    Date of Event
    December 16, 2019
    Report Date
    October 8, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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. 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 SURGEON BELIEVE THAT ETHICON PRODUCTS (VICRYL SUTURE AND PROLENE SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO POST-OP COMPLICATIONS IN CASE #3 (SUPERFICIAL WOUND INFECTION IN 77 YEARS OLD WOMAN) DESCRIBED IN THE ARTICLE? PLEASE SPECIFY. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (VICRYL SUTURE AND PROLENE SUTURE) USED FOR THIS CASE #3 IN THIS STUDY? WAS THIS CASE OF (B)(6) YEARS OLD FEMALE DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. CITATION: ANN VASC SURG 2020; 65: 288.E9¿288.E14 HTTPS://DOI.ORG/10.1016/J.AVSG.2019.11.040. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. EVENTS WERE SUBMITTED VIA 2210968-2021-09428.

    Description of Event or Problem · 1

    TITLE: VARIOUS APPROACHES TO OPEN REMOVAL OF INFERIOR VENA CAVA FILTERS CASE 3 A (B)(6)-YEAR-OLD WOMAN WITH A HISTORY OF DVT AND PE REQUIRING AN IVC FILTER PLACEMENT 2 YEARS PRIOR PRESENTED WITH ABDOMINAL PAIN, WHICH WAS FOUND ON UPPER ENDOSCOPY IN WHICH 2 STRUTS OF THE IVC FILTER WERE FOUND TO BE ERODING INTO THE DUODENUM. SUBSEQUENT CT SCAN CONFIRMED THE STRUTS IN THE DUODENUM AND ANOTHER STRUT ERODING INTO THE AORTA. THE STRUTS THAT ERODED INTO THE DUODENUM WERE CUT USING A WIRE CUTTER FLUSH WITH THE IVC AND WERE REMOVED FROM THE DUODENUM. THE SEROSA OF THE DUODENUM WAS REPAIRED PRIMARILY WITH A 3-0 VICRYL SUTURE (ETHICON). THE STRUT THAT ENTERED INTO THE AORTA WAS ALSO CUT, AND THE AORTA WAS REPAIRED WITH A 6-0 PROLENE SUTURE (ETHICON). THE REMAINING PORTION OF THE STRUTS WAS SECURED ONTO THE IVC WITH A 6-0 PROLENE SUTURE (ETHICON) TO SECURE THE FILTER IN PLACE. REPORTED COMPLICATION INCLUDED SUPERFICIAL WOUND INFECTION WHICH RESOLVED WITH ANTIBIOTICS. IN CONCLUSION WHILE OPEN IVC FILTER RETRIEVAL IS RARELY REQUIRED, VARIOUS APPROACHES CAN BE SUCCESSFULLY AND SAFELY USED FOR RETRIEVAL WITH LOW MORBIDITY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1500192 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention