BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18822571 · Received March 1, 2024

    Report

    Report Number
    2210968-2024-02255
    Event Type
    Injury
    Date Received
    March 1, 2024
    Date of Event
    May 16, 2022
    Report Date
    March 1, 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
    NP
    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. CITATION: PANTHEE ET AL. THE EGYPTIAN HEART JOURNAL (2022) 74:39 -HTTPS://DOI.ORG/10.1186/S43044-022-00278-6. RELATED EVENTS CAPTURED VIA 2210968-2024-02254.

    Description of Event or Problem · 0

    TITLE: PERICARDIAL CYST IN A ONE-YEAR-OLD BOY WITH VENTRICULAR SEPTAL DEFECT AND PATENT DUCTUS ARTERIOSUS. THE OBJECTIVE OF THIS STUDY IS TO REPORT A CASE OF ONE-YEAR-OLD BOY WITH PERICARDIAL CYST, VENTRICULAR SEPTAL DEFECT (VSD), AND PATENT DUCTUS ARTERIOSUS (PDA) WHO UNDERWENT VSD CLOSURE, PDA LIGATION, AND EXCISION OF THE PERICARDIAL CYST. A ONE-YEAR-OLD BOY WITH VENTRICULAR SEPTAL DEFECT AND PATENT DUCTUS ARTERIOSUS WAS PLANNED FOR SURGICAL CORRECTION. WITH THIS DIAGNOSIS, VSD CLOSURE AND PDA LIGATION WAS PLANNED. THE HISTOPATHOLOGY OF THE RESECTED SPECIMEN SHOWED FIBRO-COLLAGENOUS WALL WITH MILD INFLAMMATION AND MESOTHELIAL LINING CONSISTENT WITH PERICARDIAL CYST. CARDIOPULMONARY BYPASS (CPB) WAS ESTABLISHED WITH ASCENDING AORTIC AND BICAVAL CANNULATION. AFTER INITIATION OF CARDIOPULMONARY BYPASS, PDA WAS LIGATED WITH NUMBER 2 SILK SUTURE. AFTER AORTIC CROSS CLAMP, CARDIAC ARREST WAS ACHIEVED BY ANTEGRADE CARDIOPLEGIA. RIGHT ATRIUM WAS OPENED AND VSD WAS CLOSED WITH EXPANDED POLYTETRAFLUOROETHYLENE (EPTFE) PATCH USING 6¿0 PROLENE SUTURE. RIGHT ATRIUM WAS CLOSED AND AORTIC CROSS CLAMP WAS REMOVED. REPORTED COMPLICATIONS INCLUDE MILD INFLAMMATION AND MESOTHELIAL LINING CONSISTENT WITH PERICARDIAL CYST (N=1). IN CONCLUSION, PERICARDIAL CYSTS CAN SOMETIMES BE MISSED WITH TRANSTHORACIC ECHOCARDIOGRAPHY. EXCISION OF THE CYST CAN SAFELY BE DONE DURING CONCOMITANT CARDIAC SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112624 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Male Other