BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 23074537 · Received September 17, 2025

    Report

    Report Number
    2210968-2025-10571
    Event Type
    Injury
    Date Received
    September 17, 2025
    Date of Event
    June 30, 2025
    Report Date
    October 8, 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
    CH
    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: INT J CARDIOL HEART VASC. 2025 JUL 23; 60:101742. HTTPS://DOI.ORG/10.1016/J.IJCHA.2025.101742 PMID: 40734718; PMCID: PMC12305725.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). CORRECTED INFORMATION: B1, B2, H1 - ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE EVENT IS NOT RELATED TO THE DEVICE. THEREFORE, THIS MEDWATCH REPORT IS BEING VOIDED.

    Description of Event or Problem · 0

    TITLE: TRANSAPICAL BEATING-HEART SEPTAL MYECTOMY FOR THE TREATMENT OF HYPERTROPHIC OBSTRUCTIVE CARDIOMYOPATHY. THE AIM OF THIS STUDY IS TO EVALUATE THE EFFICACY AND SAFETY OF TRANSESOPHAGEAL ECHOCARDIOGRAPHY-GUIDED TRANSAPICAL MINIMALLY INVASIVE SEPTAL MYECTOMY AS A LESS TRAUMATIC ALTERNATIVE TO TRADITIONAL SEPTAL MYECTOMY FOR TREATING LEFT VENTRICULAR OUTFLOW TRACT OBSTRUCTION IN PATIENTS WITH HYPERTROPHIC OBSTRUCTIVE CARDIOMYOPATHY, WITH A FOCUS ON IMPROVING SURGICAL PRECISION AND PATIENT OUTCOMES. BETWEEN MARCH 8, 2023, AND OCTOBER 1, 2024, A TOTAL OF SEVEN PATIENTS, WITH A MEAN AGE OF 42 YEARS. TWO 2¿0 PROLENE PURSE-STRING SUTURES WITH PLEDGETS WERE PREPLACED APPROXIMATELY 2 CM LATERAL TO THE TERMINAL BRANCH OF THE LEFT ANTERIOR DESCENDING ARTERY. UNDER REAL-TIME TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) GUIDANCE, THE MYOCARDIAL RESECTION SYSTEM WAS INTRODUCED INTO THE LEFT VENTRICLE VIA THE PURSE-STRING SUTURE. PURSE-STRING SUTURES WERE TIED TO ENSURE HEMOSTASIS. REPORTED COMPLICATIONS ARE : SEVERE INTRAOPERATIVE ARRHYTHMIA WITH HEMODYNAMIC INSTABILITY (N=1) TREATMENT: A TEMPORARY PACING WIRE WAS SUTURED TO THE LEFT VENTRICLE AND CONNECTED TO AN EXTERNAL PACEMAKER, AND PERIPHERAL EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS ESTABLISHED VIA FEMORAL ARTERY AND VEIN CANNULATION. NEW-ONSET ATRIAL FIBRILLATION ACCOMPANIED BY BILATERAL PLEURAL EFFUSION (N=1) TREATMENT: WHICH IMPROVED WITH ACTIVE TREATMENT. IN CONCLUSION, ULTRASOUND-GUIDED TA-BSM DEMONSTRATED ADVANTAGES OVER THE TRADITIONAL MODIFIED MORROW PROCEDURE, INCLUDING SHORTER OPERATIVE TIMES, FASTER PATIENT RECOVERY, AND THE AVOIDANCE OF STERNOTOMY AND CARDIOPULMONARY BYPASS. COMPARED WITH ASA, TA-BSM IS ASSOCIATED WITH SIGNIFICANTLY LOWER MORTALITY RATES AND OFFERS SUPERIOR CONTROLLABILITY AND IMMEDIACY IN SEPTAL REDUCTION RELATIVE TO LIWEN¿S PERCUTANEOUS TECHNIQUE. TA-BSM IS A SAFE, EFFECTIVE, AND EASILY REPLICABLE INNOVATIVE TECHNOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2599316 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention