BEUDAMED
    FDA Adverse Event Death Summary report: N

    SILK SUTURE UNKNOWN PRODUCT

    MDR report key: 12487709 · Received September 17, 2021

    Report

    Report Number
    2210968-2021-08586
    Event Type
    Death
    Date Received
    September 17, 2021
    Date of Event
    July 2, 2020
    Report Date
    August 24, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). DEVICE NOT RETURNED. 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. ATTEMPTS ARE BEING MADE TO CLARIFY 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 ETHICON PRODUCTS (ETHIBOND SUTURE AND SILK SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE DEATH IN ONE PATIENT WITH RECURRENCE DUE TO PRE-EVENT STRENUOUS PHYSICAL EXERCISE LEADING TO A LIFE-THREATENING CARDIOPULMONARY COMPROMISE SECONDARY TO MEDIASTINAL SHIFT? DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (ETHIBOND SUTURE AND SILK SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO NON-DEATH CASES WITH POST-OP COMPLICATIONS (IPSILATERAL CHEST WALL DEFORMITY, RECURRENCES, EVISCERATION OF MOST OF SMALL BOWEL AND A TORN-OUT LATERAL STITCH) DESCRIBED IN THE ARTICLE? PLEASE SPECIFY. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (ETHIBOND SUTURE AND SILK SUTURE) USED FOR CASES IN THIS STUDY? IF YES, PLEASE PROVIDE PATIENT DEMOGRAPHICS FOR ONE PATIENT WITH RECURRENCE WHO DIED AND PATIENTS (NON-DEATH CASES) WITH POST-OPERATIVE COMPLICATIONS (IPSILATERAL CHEST WALL DEFORMITY, RECURRENCES, EVISCERATION OF MOST OF SMALL BOWEL AND A TORN-OUT LATERAL STITCH)? PLEASE CLARIFY WHAT DOES IT MEAN " A TORN-OUT LATERAL STITCH"? WERE ALL THESE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. WOULD THE AUTHOR/SURGEON LIKE TO SPEAK WITH ETHICON MEDICAL SAFETY AND ENGINEERING VIA SCHEDULED CONFERENCE CALL REGARDING THE PRODUCTS INVOLVED IN THE DEATH CASE? HAS AN AUTOPSY BEEN PERFORMED FOR DEATH CASE (ONE PATIENT WITH RECURRENCE WHICH DIED PRIOR TO TRANSFER TO THE FACILITY)? IF SO, CAN THE RESULTS BE SHARED? CITATION: SURGICAL ENDOSCOPY (2020); HTTPS://DOI.ORG/10.1007/S00464-020-07764-5 PLEASE SEE ARTICLE ATTACHED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. EVENTS WERE SUBMITTED VIA 2210968-2021-08585, 2210968-2021-08587 AND 2210968-2021-08588.

    Description of Event or Problem · 1

    TITLE: THORACOSCOPIC REPAIR OF CONGENITAL DIAPHRAGMATIC HERNIA: A NEW ANATOMICAL RECONSTRUCTIVE CONCEPT FOR TENSION DISPERSAL AT PRIMARY CLOSURE. AUTHORS: MOHAMED M. ELBARBARY, AHMED E. FARES, MAHMOUD M. MAREI, HAMED M. SELEIM CITATION: SURGICAL ENDOSCOPY (2020); HTTPS://DOI.ORG/10.1007/S00464-020-07764-5. IN THE PRESENTED STUDY, WE EXTENDED THE USE OF RIB-ANCHORING STITCHES (FREQUENTLY USED IN OPEN AND THORACOSCOPIC REPAIR OF DIAPHRAGMATIC DEFECTS) TO REORIENT THE DIAPHRAGMATIC MUSCLE LEAFLETS IN TYPES B&C-CDH, AIMING TO ACHIEVE TENSION DISPERSAL AT PRIMARY THORACOSCOPIC REPAIR. FROM 2012 TO 2018, A TOTAL OF 36 PATIENTS [MEAN AGE OF 313 DAYS (RANGE, 7 DAYS-3 YEARS)] WITH EARLY AND LATE-ONSET LATERAL CONGENITAL DIAPHRAGMATIC HERNIA WERE INCLUDED IN THE STUDY. AMONG THESE, 25 PATIENTS (17 MALE AND 8 FEMALE) HAD TYPE B DEFECTS WHILE 11 PATIENTS (9 MALE AND 2 FEMALE) HAD TYPE C DEFECTS. ALL PATIENTS UNDERWENT PRIMARY THORACOSCOPIC REPAIR WITH THE USE OF RIB-ANCHORING STITCHES. REPAIR WAS ATTEMPTED IN ALL INCLUDED CASES PRIMARILY; USING 2/0 OR 3/0 NON-ABSORBABLE BRAIDED SUTURES (ETHIBOND EXCEL®/SILK ETHICON®). REPORTED COMPLICATIONS INCLUDED. DEATH (N=1) IN A PATIENT WITH RECURRENCE DUE TO A PRE-EVENT STRENUOUS PHYSICAL EXERCISE LEADING TO A LIFE-THREATENING CARDIOPULMONARY COMPROMISE SECONDARY TO MEDIASTINAL SHIFT (A REMOTE CASE DIED PRIOR TO TRANSFER TO OUR FACILITY) ; IN CONCLUSION, IN THE PRESENTED STUDY, AUTHORS ADOPTED THORACOSCOPIC REORIENTATION OF DIAPHRAGMATIC MUSCLE LEAFLETS IN LATERAL CONGENITAL DIAPHRAGMATIC HERNIA CASES TO ACHIEVE TENSION DISPERSAL AT PRIMARY REPAIR. THE RESULTING SUTURE LINE RESEMBLED A ¿REVERSED C,¿ INSTEAD OF THE CONVENTIONAL ¿T¿-SHAPED ONE. SHORT AND MID-TERM RESULTS SUPPORTED THE EFFICACY AND REPRODUCIBILITY OF THE DESCRIBED APPROACH. HOWEVER, LONG-TERM COMPARATIVE STUDIES SEEMED A NECESSITY TO VALIDATE THESE OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1385903 SILK SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SILK GAP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death