BEUDAMED
    FDA Adverse Event Death Summary report: N

    STRATAFIX

    MDR report key: 17195411 · Received June 23, 2023

    Report

    Report Number
    3010692967-2023-00031
    Event Type
    Death
    Date Received
    June 23, 2023
    Report Date
    June 23, 2023
    Manufacturer
    SURGICAL SPECIALTIES MEXICO S. DE. R.L. DE C.V.
    Product Code
    GAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT CODE AND LOT NUMBER WERE NOT PROVIDED THEREFORE A REVIEW OF THE DEVICE HISTORY RECORDS, COMPLAINT HISTORY, STERILITY RECORDS AND/OR RETAINED SAMPLES COULD NOT BE REVIEWED. NO SAMPLES WERE RETURNED FOR REVIEW. NO MAGNIFIED PHOTOS OF THE SURGICAL SITE/EVENT WERE PROVIDED FOR REVIEW. IF THE LOT NUMBER, SAMPLES OR PHOTOS BECOME AVAILABLE AT A LATER TIME, THEY WILL BE REVIEWED, TESTED AND THE DETAILS WILL BE INCLUDED AS PART OF THE INVESTIGATION FILE. A FOLLOW-UP REPORT WILL BE SUBMITTED AT THAT TIME. WITHOUT RECEIVING THE FINISHED GOOD LOT NUMBER TO REVIEW MANUFACTURING RECORDS, STERILITY RECORDS AND RETAINED SAMPLES, RECEIVING PHOTOS OF FAILED DEVICES (IF APPLICABLE), OR RECEIVING DETAILS REGARDING THE PRE-OPERATIVE PREPARATION OF THE DEVICES, PROCEDURE PERFORMED, PLACEMENT OF THE DEVICE IN THE TISSUE, CULTURE RESULTS, PATIENT HEALTH HISTORY/PAST REACTIONS TO SUTURE MATERIAL/OTHER MEDICAL DEVICES, DETAILS OF POST-OPERATIVE EVENTS THAT MAY HAVE OCCURRED FOLLOWING SURGERY, A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT CANNOT BE CONFIRMED WITH CERTAINTY OTHER PRODUCTS NOT MANUFACTURED BY CORZA INVOLVED IN THE EVENT MENTIONED IN STUDY. MONOCRYL, POLIGLECAPRONE 25, SUTURE UNKNOWN, VICRYL 4.0 SINGLE STITCHES, POLIGLECAPRONE 25, VICRYL STITCHES.STRATAFIX 3.0 BIDIRECTIONAL SPIRAL KNOTLESS SUTURE, VICRYL 3.0 STAY SUTURES WERE PLACED TO HOLD THE LUMEN WIDE, VICRYL POLYGLACTIN 910 SUTURE UNKNOWN, STAPLES.

    Description of Event or Problem · 0

    OUR AFFILIATE REPORTED THE FOLLOWING CLINICAL STUDY: TITLE: CONTINUOUSLY SUTURED VERSUS LINEAR-STAPLED ANASTOMOSIS IN ROBOT-ASSISTED HYBRID IVOR LEWIS ESOPHAGEAL SURGERY FOLLOWING NEOADJUVANT CHEMORADIOTHERAPY: A SINGLE-CENTER COHORT STUDY AUTHORS: FIORENZO V. ANGEHRN, KERSTIN J. NEUSCHÜTZ, LANA FOURIE, PAULINE BECKER, MARKUS VON FLÜE, DANIEL C. STEINEMANN, MARTIN BOLLI CITATION: SURGICAL ENDOSCOPY (2022) 36:9435¿9443. HTTPS://DOI.ORG/10.1007/S00464-022-09415-3 THE AIM OF THIS STUDY WAS TO ANALYZE PERIOPERATIVE MORBIDITIES AND SHORT-TERM OUTCOMES IN PATIENTS UNDERGOING HYBRID ROBOT-ASSISTED ESOPHAGEAL SURGERY FOLLOWING NEOADJUVANT CHEMORADIOTHERAPY (NCRT), WITH COSU OR LIST ANASTOMOSES IN A SINGLE CENTER. FOLLOWING STANDARDIZED, EFFECTIVE, NCRT, 53 PATIENTS UNDERWENT A HYBRID IVOR LEWIS ROBOTASSISTED ESOPHAGECTOMY WITH COSU (N = 32) OR LIST (N = 21) GASTROESOPHAGEAL ANASTOMOSES. THE STAPLE LINE WAS THEN FURTHER SECURED WITH MULTIPLE STITCHES WITH MONOCRYL. IN LIST TECHNIQUE THE ANTERIOR WALL OF THE ANASTOMOSIS WAS SUTURED WITH TWO STRATAFIX 3.0 CONTINUOUS SUTURES AND AN ADDITIONAL LAYER OF SINGLE 3.0 VICRYL STITCHES. THE END-TO-SIDE ESOPHAGOGASTROSTOMY BY COSU TECHNIQUE WAS PERFORMED USING A CONTINUOUS STRATAFIX 3.0 BIDIRECTIONAL SPIRAL KNOTLESS SUTURE. BEFORE STARTING THE RUNNING SUTURE FROM THE POSTERIOR WALL TOWARD BOTH SIDES OF THE ANTERIOR PART, TWO VICRYL 3.0 STAY SUTURES WERE PLACED TO HOLD THE LUMEN WIDE OPEN. ADDITIONAL VICRYL 4.0 SINGLE STICHES WERE CAREFULLY PLACED FOR FURTHER ADAPTATION WITHOUT COMPROMISING PERFUSION. COMPLETION OF THE CIRCULAR ANASTOMOSIS, THE TWO ENDS OF THE CONTINUOUS SUTURES WERE KNOTTED AND THE ANASTOMOSIS WAS SECURED WITH A SECOND LAYER OF 3.0 VICRYL INTERRUPTED SUTURES. AN OMENTAL PATCH WAS PLACED OVER THE ANASTOMOSIS AND ATTACHED TO THE PLEURA WITH THREE VICRYL 3.0 SUTURES IN BOTH TECHNIQUES. REPORTED COMPLICATIONS INCLUDED COSU GROUP: ANASTOMOTIC LEAKAGE (N=3), PLEURAL EMPYEMA (N=1), MORTALITY (N=1) , DYSPHAGIA (N=4), DYPNEA (N=1)- , ANASTOMOTIC STENOSIS (N=1), DELAYED WOUND HEALING LIST GROUP: ANASTOMOTIC LEAKAGE (N=2), PLEURAL EMPYEMA (N=2), MORTALITY DUE TO SEVERE SEPSIS (N=1), DYSPHAGIA (N=1), NECROSIS IN CONCLUSION COSU IS NOT INFERIOR TO LIST IN THE PERFORMANCE OF GASTROESOPHAGEAL ANASTOMOSIS IN HYBRID IVOR LEWIS OPERATIONS FOLLOWING NCRT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1865876 STRATAFIX UNKNOWN POLYPROPLENE GAW SURGICAL SPECIALTIES MEXICO S. DE. R.L. DE C.V. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death