BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18848045 · Received March 6, 2024

    Report

    Report Number
    2210968-2024-02523
    Event Type
    Injury
    Date Received
    March 6, 2024
    Date of Event
    January 3, 2023
    Report Date
    March 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
    GM
    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 THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: REV. CARDIOVASC. MED. 2023; 24(1): 4. HTTPS://DOI.ORG/10.31083/J.RCM2401004

    Description of Event or Problem · 0

    TITLE: PERIOPERATIVE SAFETY OF BILATERAL INTERNAL THORACIC ARTERY CORONARY BYPASS IN ELDERLY THE PRIMARY OBJECTIVE OF THIS RETROSPECTIVE SINGLE-CENTER STUDY IS TO EVALUATE THE SAFETY OF HARVESTING BOTH ITAS IN THE ELDERLY BY COMPARING THE SHORT-TERM RESULTS IN PATIENTS WHO ARE 75 YEARS OF AGE AND OLDER WHO RECEIVED EITHER SINGLE LEFT (SITA) OR DOUBLE (DITA) INTERNAL THORACIC ARTERY GRAFTS. BETWEEN JAN 1ST 2002 AND DEC 31ST 2020, A TOTAL OF 1855 PATIENTS UNDERGOING CORONARY ARTERY BYPASS GRAFT SURGERY (CABG) WAS INCLUDED, OF WHICH 1114 (758 MALE AND 356 FEMALE; MEAN AGE OF 79.2 ± 3.0 YEARS) RECEIVED A SINGLE LEFT (S)ITA AND 741 (544 MALE AND 197 FEMALE; MEAN AGE OF 78.8 ± 2.8 YEARS) RECEIVED COMBINED LEFT AND RIGHT (D)ITA GRAFTS. 519 PAIRS WERE MATCHED. SINGLE LEFT (SITA) OR DOUBLE (DITA) WERE HARVESTED USING A SKELETONIZED OR PEDICLE TECHNIQUE. SKELETONIZATION WAS PERFORMED USING AN ULTRASONIC SCALPEL (HARMONIC SYNERGY BLADES ®, ETHICON GMBH, NORDERSTEDT, GERMANY) TO OPEN THE ENDOTHORACIC FASCIA AND DISSECT THE ITA FROM THE ADJACENT VEINS. THE ITA BRANCHES WERE COAGULATED BY APPLYING THE TIP OF THE BLADE DIRECTLY ONTO THE VESSEL FOR 3¿5 SECONDS. HEMOSTATIC TITANIUM CLIPS WERE ONLY USED FOR MAJOR BRANCHES. FOR THE PEDICLE TECHNIQUE, AN ELECTRICAL KNIFE WAS USED (UNKNOWN MANUFACTURER). ANASTOMOSES WERE CONDUCTED USING POLYPROPYLENE SUTURES (ETHICON PROLENE SUTURE 7-0 OR 8-0). REPORTED COMPLICATIONS INCLUDE MYOCARDIAL INFARCTION (N=22), STERNAL WOUND HEALING DISORDERS (N=80), BLEEDING OR TAMPONADE (N=61), GRAFT PROBLEMS (N=12), STERNAL INSTABILITY OR INFECTION (N=28), AND LOW CARDIAC OUTPUT OR CPR (N=3). IN CONCLUSION, HARVESTING BOTH ITA IN ELDERLY PATIENTS IS SAFE AND FEASIBLE. HOWEVER, IT IS ASSOCIATED WITH INCREASE IN THE INCIDENCE OF STERNAL WOUND HEALING DISORDERS. WHEN DONE, ATTENTION IS REQUIRED TO CONTROL OTHER FACTORS INFLUENCING THE WOUND HEALING. LONG-TERM BENEFIT OF DITA GRAFTING STILL NEEDS TO BE PROVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196311 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention