BEUDAMED
    FDA Adverse Event Death Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 7400738 · Received April 5, 2018

    Report

    Report Number
    2210968-2018-71942
    Event Type
    Death
    Date Received
    April 5, 2018
    Report Date
    March 19, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PDS SUTURES USED IN THIS PROCEDURE LEADING TO LOCAL RELAPSE OR ANASTOMOTIC COMPLICATION? DOES THE SURGEON BELIEVE THAT ETHICON SUTURES INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATION OF DEATH DUE TO ANASTOMOTIC COMPLICATION DESCRIBED IN THE ARTICLE? PLEASE CONTACT THE AUTHOR/ SURGEON TO OFFER A CONVERSATION WITH ETHICON MEDICAL AND ENGINEERING (TRANSLATION IS AVAILABLE). CITATION: HEART, LUNG AND CIRCULATION (2015) 24, 1027¿1032; DOI: HTTP://DX.DOI.ORG/10.1016/J.HLC.2015.04.065. [(B)(4)- LUCIANO 2015 (4).PDF].

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE JOURNAL ARTICLE TITLE: TRACHEO-BRONCHOPLASTIC PROCEDURES FOR NSCLC: SINGLE-CENTRE EXPERIENCE. AUTHOR(S): GIULIA LUCIANO, MD, FRANCO STELLA, MD, ANDREA DELL¿AMORE, MD, GIAMPIERO DOLCI, MD, GRECO DOMENICO, MD, ALESSANDRO BINI, MD CITATION: HEART, LUNG AND CIRCULATION (2015) 24, 1027¿1032; DOI: HTTP://DX.DOI.ORG/10.1016/J.HLC.2015.04.065. THE PURPOSE OF THIS SINGLE-CENTRE STUDY WAS TO ASSESS OPERATIVE MORTALITY, MORBIDITY, AND LONG-TERM RESULTS OF THE TOTALITY OF SLEEVE RESECTIONS PERFORMED AT OUR INSTITUTIONS OVER THE LAST EIGHT YEARS, INCLUDING SLEEVE LOBECTOMIES (SL), CRANIOPLASTIES WITH TOTAL LUNG SPARING (CP) AND SLEEVE PNEUMONECTOMIES (SP). BETWEEN JAN2004 AND DEC2012, 22 PATIENTS (N=19 MALE AND N=3 FEMALE; AGES 37 TO 80 YEARS) WITH BRONCHIAL CANCER UNDERWENT ELECTIVE TRACHEO-BRONCHIAL (SLEEVE) RESECTION. SLEEVE LOBECTOMIES WERE PERFORMED IN 14 PATIENTS, SLEEVE PNEUMONECTOMIES WERE PERFORMED IN 7 PATIENTS AND 1 PATIENT HAD CRANIOPLASTIES WITH TOTAL LUNG SPARING. IN THE PROCEDURE, A CONTINUOUS RUNNING SUTURE WITH 4-0/3-0 PDS (ETHICON INC.) WAS USED ON THE MEMBRANOUS PORTION AND AN INTERRUPTED PDS SUTURE FOR THE CARTILAGE WALL. THERE WERE ALSO THREE CASES OF DOUBLE SLEEVE WITH PARTIAL INFILTRATION OF THE ARTERIAL SEGMENT AND TANGENTIAL RESECTION AND DIRECT SUTURE WITH 6-0 NON-ABSORBABLE POLYPROPYLENE RUNNING SUTURE (PDS, ETHICON1) WAS SUFFICIENT. COMBINED ARTERIAL-BRONCHIAL SLEEVE RESECTION WAS PERFORMED THE SOFT FLAP WAS LAID BETWEEN THE VASCULAR SUTURE PLAIN AND THE BRONCHIAL ANASTOMOTIC SITE TO PREVENT POTENTIAL BRONCHOVASCULAR FISTULA. TWO PERI-OPERATIVE DEATHS FOR ANASTOMOTIC DEHISCENCE AND CARDIOVASCULAR ACUTE ACCIDENT OCCURRED AFTER SP. THERE WERE FOUR CASES OF LOCAL RELAPSE WHICH LED TO DEATH, AND FOR WHICH TWO OF THEM HAD DOUBLE SLEEVE. IN THIS STUDY WE FOUND A TENDENCY TO LOCAL RELAPSE, IN FACT TWO OF THE THREE CASES OF ¿DOUBLE SLEEVE¿ HAD A RECURRENCE IN THE MIDDLE TERM WITH A DISEASE FREE INTERVAL (DFI) OF 11 AND 34 MONTHS, RESPECTIVELY. THE REMAINING DEATHS OCCURRED AFTER SYSTEMIC ACUTE ACCIDENTS NOT DIRECTLY RELATED TO SURGICAL PROCEDURES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244360 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death