BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18772945 · Received February 23, 2024

    Report

    Report Number
    2210968-2024-01844
    Event Type
    Injury
    Date Received
    February 23, 2024
    Date of Event
    September 9, 2022
    Report Date
    March 14, 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
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: JOURNAL OF THORACIC DISEASE, (2022); 14 (10): 3831-3841. HTTPS://DX.DOI.ORG/10.21037/JTD-22-828.

    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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: NO FURTHER INFORMATION WILL BE PROVIDED BECAUSE WE CAN¿T GET ANY ADDITIONAL INFORMATION FROM THE AUTHOR.

    Description of Event or Problem · 0

    TITLE: PATCH AUGMENTATION VS. VALVE REPLACEMENT FOR PATIENTS WITH ATRIAL FUNCTIONAL MITRAL REGURGITATION AND LONG-STANDING ATRIAL FIBRILLATION. THEY RETROSPECTIVELY COMPARED THE DATA OF 16 PATIENTS WHO UNDERWENT PA FOR AFMR WITH THE DATA OF 15 PATIENTS WHO UNDERWENT VR BETWEEN 2008 AND 2021. THEY DEFINED AFMR WITH A TETHERED POSTERIOR LEAFLET AS SEVERE SHORTENING AND TETHERING OF THE POSTERIOR LEAFLET AND MITRAL ANNULAR DILATATION WITH OR WITHOUT PSEUDO-PROLAPSE OF THE ANTERIOR LEAFLETS IN ACCORDANCE WITH THE GUIDELINES OF THE JAPANESE CIRCULATION SOCIETY. THEY PERFORMED MITRAL VALVE SURGERY FOR AFMR USING THE CONVENTIONAL APPROACH, WHICH CONSISTED OF CARDIOPULMONARY BYPASS WITH ASCENDING AORTIC CANNULATION AND BICAVAL VENOUS CANNULATION TO THE SUPERIOR AND INFERIOR VENA CAVA THROUGH A MEDIAN STERNOTOMY. THEY APPROACHED THE MITRAL VALVE THROUGH THE INFERIOR APPROACH OR THE TRANSSEPTAL APPROACH. THEY PERFORMED AORTIC VR OR CORONARY ARTERY BYPASS GRAFTING IN THE CONVENTIONAL FASHION DURING CARDIAC ARREST IF NECESSARY. IN THE PA GROUP, THEY PERFORMED PA WITH FRESH AUTOLOGOUS PERICARDIUM WITHOUT GLUTARALDEHYDE FIXATION FOR AFMR TO OBTAIN AN ADEQUATE COAPTATION LENGTH WHEN THE POSTERIOR LEAFLET WAS SHORTER THAN 10 MM. PA REPAIR CONSISTED OF TRANSVERSELY CUTTING THE CENTER OF THE SHORTENED POSTERIOR LEAFLET AND SEWING THE PERICARDIAL PATCH USING CONTINUOUS SUTURE WITH 5-0 MONOFILAMENT POLYPROPYLENE. IN THE VR GROUP, THEY PLACED A BIOPROSTHETIC VALVE OR MECHANICAL VALVE WITH NON-EVERTING OR EVERTING MATTRESS SPAGHETTI-PLEDGED 2-0 POLYESTER SUTURE. LEFT ATRIAL PLICATION USING HORIZONTAL MATTRESS AND CONTINUOUS 4-0 PROLENE SUTURE WITH A FELT PLEDGET WAS PERFORMED. THE MEDIAN FOLLOW-UP DURATION WAS 1.7 YEARS [INTERQUARTILE RANGE (IQR), 1.2¿3.9 YEARS]. THE MEDIAN FOLLOW-UP INDEX WAS 0.93 [IQR, 0.56¿0.98]. THE FOLLOWING EVENTS CANNOT BE RULED OUT AS COMPLAINTS: PATIENT INFORMATION: 4-0 PROLENE SUTURE VR GROUP: (N=3) RE-EPLORATION FOR BLEEDING (N=6) READMITTED TO HOSPITAL OWING TO CONGESTIVE HEART FAILURE ASSOCIATED WITH CHRONIC ATRIAL FIBRILLATION, INCLUDING ONE PATIENT WITH A PERMANENT PACEMAKER FOR SICK SINUS SYNDROME. (N=1) CEREBRAL BLEEDING TREATMENT: NO TREATMENT MENTIONED IN THIS GROUP IN CONCLUSIONS, PA REPAIR FOR AFMR CAUSED BY SEVERE POSTERIOR LEAFLET SHORTENING WITH ATRIAL ENLARGEMENT MAY ACHIEVE GOOD OUTCOMES THAT ARE COMPARABLE WITH THOSE OF VR. HOWEVER, PA REPAIR REQUIRED A LONGER CARDIOPULMONARY BYPASS TIME AND HAD A HIGHER REOPERATION RATE THAN VR. THEREFORE, IN HIGH-RISK PATIENTS, VR MAY BE A GOOD CHOICE BECAUSE OF ITS GOOD MID-TERM OUTCOMES WITHOUT REOPERATION, ESPECIALLY FOR NON-EXPERT SURGEONS. SURGICAL PROCEDURES SHOULD BE CHOSEN WHILE CONSIDERING THE PATIENT¿S BACKGROUND. ATRIAL REDUCTION SURGERY WITH APPROPRIATE VOLUME REDUCTION COULD BE CONSIDERED TO PREVENT THROMBOEMBOLIC EVENTS BECAUSE THE POSTOPERATIVE LAVI IS ASSOCIATED WITH THROMBOEMBOLIC EVENTS AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113826 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention