BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18650495 · Received February 6, 2024

    Report

    Report Number
    2210968-2024-00986
    Event Type
    Injury
    Date Received
    February 6, 2024
    Date of Event
    June 27, 2020
    Report Date
    February 6, 2024
    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

    (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 CITATION: HTTPS://DOI.ORG/10.1136/BCR-2020-235464.

    Description of Event or Problem · 0

    TITLE: INTRAVASCULAR ULTRASOUND- GUIDED MECHANICAL THROMBECTOMY USING THE INARI CLOTTRIEVER DEVICE OF AN IATROGENIC DEEP VENOUS THROMBOSIS. A 66- YEAR- OLD WOMAN WITH A HISTORY OF HYPERTENSION AND CHRONIC BACK PAIN PRESENTED FOR ELECTIVE LUMBAR SPINAL FUSION THROUGH AN ANTEROPOSTERIOR APPROACH. THE SURGERY WAS COMPLICATED WITH LEFT ILIAC VEIN LACERATION THAT WAS REPAIRED WITH PROLENE (ETHICON) SUTURING. POSTOPERATIVELY, THE PATIENT WAS INITIATED ON PROPHYLACTIC DOSES OF SUBCUTANEOUS HEPARIN EVERY 8 HOURS; HOWEVER, ON THE SECOND POSTOPERATIVE DAY, THE PATIENT DEVELOPED PROGRESSIVE SWELLING OF THE LEFT LOWER EXTREMITY UP TO THE THIGH WITH ASSOCIATED PAIN AND REDNESS. THE LEFT LOWER EXTREMITY HAD EVIDENCE OF SEVERE SWELLING EXTENDING FROM THE FOOT TO THE UPPER THIGH WITH SIGNIFICANT TENDERNESS. THE REPORTED COMPLICATIONS INCLUDED (N=1) SWELLING TREATMENT: SURGERY AND MEDICATION, (N=1) PAIN TREATMENT: MEDICATION, (N=1) TENDERNESS AND REDNESS TREATMENT: SURGERY AND MEDICATION. IN CONCLUSION, THE INCIDENCE OF VENOUS THROMBOEMBOLISM (VTE) IS 1 TO 2 PER 1000 OF THE US POPULATION.1¿3 IT HAS BOTH GENETIC AND ACQUIRED RISK FACTORS.4¿6 IATROGENIC VTE REPRESENTS ONE OF THE ACQUIRED RISK FACTORS THAT MIGHT RESULT IN EXTENSIVE VENOUS THROMBOSIS. ANTICOAGULATION IS THE STANDARD OF CARE FOR THE MANAGEMENT OF VTE. HOWEVER, IT IS ESSENTIAL TO MONITOR THE RESPONSE TO TREATMENT AND FOR ANY SIGNS OF IMPENDING VASCULAR COMPROMISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495602 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention