BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 22953890 · Received September 3, 2025

    Report

    Report Number
    2210968-2025-10073
    Event Type
    Injury
    Date Received
    September 3, 2025
    Date of Event
    January 15, 2025
    Report Date
    September 3, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. CITATION: J VASC SURG CASES INNOV TECH. 2025 JAN 15;11(2):101734. DOI: 10.1016/J.JVSCIT.2025.101734. PMID: 40026648; PMCID: PMC11870240. HTTPS://DOI.ORG/10.1016/J.JVSCIT.2025.101734.

    Description of Event or Problem · 0

    A CASE OF MYCOTIC COMMON ILIAC ANEURYSM IN A PATIENT WITH VENTRICULOPERITONEAL SHUNT. THIS REPORT DISCUSSES THE ULTIMATELY SUCCESSFUL MANAGEMENT OF A LARGE AORTOILIAC MYCOTIC ANEURYSM. THE PATIENT DID CONTEND WITH BACTERIAL MENINGITIS POSTOPERATIVELY, LIKELY OWING TO AN ASCENDING INFECTION OF THE AFOREMENTIONED SHUNT. THE PATIENT IS A 76-YEAR-OLD WOMAN WITH A HISTORY OF PERIPHERAL ARTERY DISEASE AND RUPTURED CEREBRAL ANEURYSM FOR WHICH A VENTRICULOPERITONEAL (VP) SHUNT WAS PLACED 20 YEARS PRIOR. SHE INITIALLY PRESENTED WITH ACUTE-ONSET LOW ABDOMINAL PAIN. HER COMPUTED TOMOGRAPHY SCAN REVEALED PERIAORTITIS WITH RETROPERITONEAL FIBROSIS, WHICH WAS TREATED MEDICALLY. THE ABDOMEN WAS IRRIGATED THOROUGHLY AND THE AORTA AND COMMON ILIAC VESSELS WERE LIGATED WITH PROLENE SUTURE. A DRAIN WAS LEFT IN THE RETROPERITONEUM. TO MITIGATE CONTAMINATION FROM THE INFECTED ABDOMEN, THE DECISION WAS MADE TO EXTERIORIZE THE VP SHUNT. THE MEAN DURATION FOLLOW-UP WAS 2 MONTHS. REPORTED COMPLICATION: PROLENE SUTURE (ETHICON): (N=1)METHICILLIN-SENSITIVE S AUREUS BACTERIAL MENINGITIS. TREATMENT: SHE REQUIRED NEUROSURGICAL INTERVENTION AND A TEMPORARY EXTERNAL VENTRICULAR DRAIN UNTIL SOURCE CONTROL COULD BE GUARANTEED. AFTER EXTENDED-DURATION ANTIMICROBIAL THERAPY AND A PROLONGED SURGICAL INTENSIVE CARE UNIT COURSE, BACTERIAL CULTURES CLEARED AND THE ABDOMEN WAS FELT TO BE STERILE. A NEW VP SHUNT WAS CREATED AND PLACED IN THE UPPER ABDOMEN LAPAROSCOPICALLY. IN CONCLUSIONS, AORTOILIAC MYCOTIC ANEURYSM IS A LIFE-THREATENING CONDITION, WITH OPERATIVE MORTALITY AS HIGH AS 20%.26 THE CAUSE OF THIS PATIENT¿S ORIGINAL RETROPERITONEAL INFECTION REMAINS UNCLEAR, AS THERE WAS NO RECENT INFECTIOUS HISTORY AND NO SURGERY SINCE VP SHUNT PLACEMENT 20 YEARS PRIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1473380 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention