BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 19066906 · Received April 8, 2024

    Report

    Report Number
    2210968-2024-04032
    Event Type
    Injury
    Date Received
    April 8, 2024
    Date of Event
    March 24, 2023
    Report Date
    April 8, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). COMPONENT CODE: G07002 - DEVICE NOT RETURNED. THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORD EVALUATION CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. 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. 1. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER(S). 2. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE PATIENT CONSEQUENCES DESCRIBED IN THE ARTICLE? 3. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? 4. WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; PRESCRIPTION STEROIDS; ANTIBIOTICS PRESCRIBED)? IF SO, PLEASE CLARIFY. 5. CAN SPECIFIC PATIENT DEMOGRAPHICS: INITIALS; AGE OR DATE OF BIRTH; BMI; GENDER; PATIENT PRE-EXISTING MEDICAL CONDITIONS (I.E. ALLERGIES, HISTORY OF REACTIONS), ALL CONCOMITANT MEDICATIONS, PAST MEDICAL HISTORY, ANY TREATMENT REQUIRED FOR EVENTS, DOSE, FREQUENCY, AND THERAPY DATES OF STUDY DRUGS BE PROVIDED? CITATION: EUROPEAN JOURNAL OF OBSTETRICS AND GYNECOLOGY 284 (2023) 150¿161; HTTPS://DOI.ORG/10.1016/J.EJOGRB.2023.03.026. EVENT RELATED TO MW # 2210968-2024-04031, MW # 2210968-2024-04033. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A JOURNAL ARTICLE: TITLE: KASR ALAINY SIMPLIFIED UTERINE PRESERVING SURGERY FOR CONSERVATIVE MANAGEMENT OF PLACENTA ACCRETA SPECTRUM (PAS): A MODIFIED SURGICAL APPROACH AUTHOR(S): ABDALLA MOUSA, ISLAM T. ELKHATEB, HASSAN M. GAAFAR, MOUTAZ M. ELSHERBINI, HATEM MOUSA, MOSTAFA ABDALLA, AHMED ABDELBAR, DANA RIDA, HOOMAN SOLEYMANI MAJD, SALLY L. COLLINS CITATION: EUROPEAN JOURNAL OF OBSTETRICS AND GYNECOLOGY 284 (2023) 150¿161; HTTPS://DOI.ORG/10.1016/J.EJOGRB.2023.03.026 THIS STUDY AIMS TO DESCRIBE AND DEMONSTRATE THE KASR ALAINY MODIFIED TECHNIQUE FOR UTERINE PRESERVING SURGERY. IT IS SUPPORTED WITH ILLUSTRATIONS, SURGICAL IMAGES, AND VIDEOS TO MAXIMIZE THE READER¿S UNDERSTANDING OF THIS TECHNIQUE AND TO HELP MAKE IT REPRODUCIBLE. BETWEEN (B)(6) 2020, 20 PATIENTS WITH ANTENATALLY SUSPECTED PLACENTA ACCRETA SPECTRUM THAT WERE CONFIRMED AT LAPAROTOMY WERE INCLUDED IN THE STUDY. THE PATIENTS¿ MEAN AGE WAS 29.5 ± 4.7 YEARS AND THE MEAN BMI WAS 30.5 ± 2.5 KG/M2. THE MEAN NUMBER OF PREVIOUS CESAREAN SECTIONS WAS 2.05 (STANDARD DEVIATION (SD): ±1.05) AND THE EAN PARITY WAS 1.85 (SD: ±0.93). 18 PATIENTS DELIVERED AT 36 WEEKS OF GESTATION, WHILE 2 WOMEN DELIVERED BEFORE 36 WEEKS. THE KASR ALAINY SIMPLIFIED UTERINE PRESERVING SURGERY INVOLVED DISSECTION OF THE URINARY BLADDER FROM THE ANTERIOR UTERINE WALL. DEVASCULARISATION OF THE NEWLY FORMED VESSELS BETWEEN THE ANTERIOR SURFACE OF THE UTERUS AND THE POSTERIOR BLADDER WALL WAS DONE BY EITHER DIRECT CAUTERIZATION OR LIGATION WITH 2.0 VICRYL (ETHICON) SUTURES AT THE 2 ENDS OF THE VESSEL. A TRANSVERSE UTERINE INCISION JUST ABOVE THE PLACENTA ACCRETA SPECTRUM UPPER BORDER. AFTER THE DELIVERY OF THE BABY, THE UTERUS IS EXTERIORIZED WITHOUT ATTEMPTING TO SEPARATE THE PLACENTA. THE INCISION EDGES ARE APPROXIMATED WITH TOWEL CLAMPS TO REDUCE THE BLOOD LOSS. PLACENTA ACCRETA SPECTRUM PLACENTAL BED DEVASCULARISATION WAS ACHIEVED BY LIGATING THE UTERINE ARTERIES ON BOTH SIDES JUST BELOW THE AREA OF PLACENTA ACCRETA SPECTRUM USING 1.0 VICRYL (ETHICON) SUTURES. THEN, AN EN BLOC RESECTION OF THE INVADED SEGMENT OF UTERINE WALL ALONG WITH THE INVADING PLACENTA WAS PERFORMED. MYOMETRIAL RECONSTRUCTION IN 2 LAYERS WAS PERFORMED USING CONTINUOUS 1.0 VICRYL (ETHICON) SUTURES. INTERRUPTED SIMPLE SUTURES OR COAGULATION DIATHERMY WERE USED FOR BLEEDING POINTS, AND SURGICEL (ETHICON) WAS PLACED OVER THE OOZING SURFACES. A 24 FRENCH INTRAPERITONEAL DRAIN WAS INSERTED INTO THE RECTOVESICAL REGION. FINALLY, THE ABDOMEN WAS CLOSED IN LAYERS, AND THE RECTUS SHEATH WAS CLOSED WITH 1.0 PDS (ETHICON) LOOP CONTINUOUS RUNNING SUTURES. REPORTED COMPLICATIONS INCLUDED WOUND INFECTION (N=1) AND SIGNIFICANT CESAREAN SCAR NICHE (>1 CM3) (N=1). IN CONCLUSION, OUR SURGICAL TECHNIQUE IS SAFE AND MAY BE USEFUL FOR CONSERVATIVE SURGICAL MANAGEMENT OF PLACENTA ACCRETA SPECTRUM, PARTICULARLY IN LOW- AND MIDDLE-INCOME COUNTRIES, WHERE ACCESS TO COMPLEX RESOURCES, SUCH AS INTERVENTIONAL RADIOLOGY, IS LIMITED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96265 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other