BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7359943 · Received March 21, 2018

    Report

    Report Number
    2210968-2018-71603
    Event Type
    Injury
    Date Received
    March 21, 2018
    Report Date
    March 2, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT TO THE FDA: 03/21/2018. (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. 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. WAS THIS REPORTED TO ETHICON PREVIOUSLY? IS THERE AN ALLEGED DEFICIENCY AGAINST THE ETHICON PRODUCTS (SURGICEL AND VICRYL POLYGLACTIN SUTURE)? DOES THE PRINCIPAL INVESTIGATOR OPINE THAT THE AES ARE ATTRIBUTED TO THE USE OF SURGICEL AND/OR VICRYL POLYGLACTIN SUTURE? IF SO, CAN SPECIFIC PATIENT DEMOGRAPHICS BE PROVIDED FOR THE SUBJECTS OF THIS ARTICLE? IF SO, PLEASE INCLUDE: PRE-EXISTING CONDITIONS, EXACT PROCEDURE PERFORMED (IF NOT ALREADY SPECIFIED IN THE LITERATURE), SPECIFIC MEDICAL/ SURGICAL INTERVENTION PER PATIENT. THE PRODUCT CODE AND LOT NUMBER. CITATION: JOURNAL OF LAPAROENDOSCOPIC & ADVANCED SURGICAL TECHNIQUES VOLUME 24, NUMBER 5, 2014 ª MARY ANN LIEBERT, INC.; DOI: 10.1089/LAP.2013.0333. (B)(4).

    Description of Event or Problem · 1

    TITLE: ¿¿OFF-CLAMP, NON-RENORRHAPHY¿¿ LAPAROSCOPIC PARTIAL NEPHRECTOMY WITH PERIRENAL FAT AND GEROTA¿S FASCIA REAPPROXIMATION: INITIAL EXPERIENCE AND PERIOPERATIVE OUTCOMES. THE PURPOSE OF THIS PROSPECTIVE REVIEW IS TO DESCRIBE THE INITIAL EXPERIENCE OF THE AUTHORS IN ¿¿OFF-CLAMP, NON-RENORRHAPHY¿¿ LAPAROSCOPIC PARTIAL NEPHRECTOMY (OCNR-LPN) WITH PERIRENAL FAT AND GEROTA¿S FASCIA REAPPROXIMATION TECHNIQUE. BETWEEN AUGUST 2012 AND MARCH 2013, 24 CONSECUTIVE PATIENTS UNDERWENT OCNR-LPN WERE INCLUDED IN THE STUDY. AFTER SOME INITIAL EXPERIENCE, SELECTED PATIENTS WITH LOW RENAL NEPHROMETRY SCORE (RNS) RENAL TUMORS WERE CHOSEN TO UNDERGO RENAL MASS EXCISION WITHOUT RENAL VESSEL MANIPULATION. THE SPACE OF THE EXCISED MASS WAS THEN FILLED WITH SURGICEL_ (ETHICON, A JOHNSON & JOHNSON COMPANY, (B)(4)) BOLSTERS. AFTER WHICH BOTH THE PERIRENAL FAT AND GEROTA¿S FASCIA REAPPROXIMATED WITHOUT PARENCHYMAL RENORRHAPHY USING 3-0 POLYGLACTIN 910 (VICRYL_; ETHICON) CONTINUOUS SUTURES. ABDOMINAL COMPUTED TOMOGRAPHY SCAN PERFORMED 1 MONTH POSTOPERATIVELY REVEALS A SMALL HEMATOMA-LIKE LESION IN THE RESECTED TUMOR SITE, WHICH IS LIKELY RESULTED FROM BLOOD CLOT AGGREGATION FROM SURGICEL BOLSTERS OR GELFOAM. PARALYTIC ILEUS (N=1) WHICH WAS TREATED WITH PERCUTANEOUS DRAINAGE AND ANTIBIOTICS, POST-OPERATIVE URINE LEAKAGE (N=2) WHICH WAS TREATED WITH TEMPORARY URETERAL STENTING UNDER LOCAL ANESTHESIA AND PERIRENAL ABSCESS (N=1) WERE ALSO REPORTED. THE AUTHORS CONCLUDED THAT IN THEIR INITIAL EXPERIENCE OF OCNR-LPN, THERE WAS VIRTUALLY NO CHANGES IN POSTOPERATIVE RENAL FUNCTION AND MINIMAL COMPLICATIONS COMPARED WITH CONVENTIONAL LPN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199546 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention