BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7681308 · Received July 12, 2018

    Report

    Report Number
    2210968-2018-74277
    Event Type
    Injury
    Date Received
    July 12, 2018
    Report Date
    June 20, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT THE ETHICON PRODUCT INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POSTOPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? IF YES, PLEASE EXPLAIN DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT USED IN THIS PROCEDURE? IF YES, PLEASE EXPLAIN CITATION: THE JOURNAL OF CARDIOVASCULAR SURGERY. 2017; 58(6): 904-8. DOI: 10.23736/S0021-9509.16.09010-8. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: CONTROL OF MAJOR PULMONARY ARTERY BLEEDING WITH A GELATIN MATRIX-THROMBIN SOLUTION: A RETROSPECTIVE ANALYSIS. AUTHOR: GIUSEPPE CARDILLO, FRANCESCO CARLEO, MARCO DI MARTINO, BERNARDO CIAMBERLANO, PASQUALE IALONGO, GIACOMO CUSUMANO, MARIA DENITZA TINTI, ALBERTO RICCI, STEFANO CAFAROTTI CITATION: THE JOURNAL OF CARDIOVASCULAR SURGERY. 2017; 58(6): 904-8. DOI: 10.23736/S0021-9509.16.09010-8. INTRAOPERATIVE PULMONARY ARTERY (PA) BLEEDING IS COMMON DURING THORACIC SURGERY. THE AUTHORS INVESTIGATED THE EFFICACY OF FLOSEAL FOR CONTROL OF MAJOR PA BLEEDING. A TOTAL OF 39 PATIENTS WITH INTRAOPERATIVE PA INJURY WERE IDENTIFIED. OF WHICH, 21 PATIENTS (14 MALE 7 FEMALE; AGE: 71.3 ± 5.9) RECEIVED STANDARD CARE (STANDARD GROUP) WHILE 18 PATIENTS (13 MALE AND 5 FEMALE PATIENTS; AGE: 70.2 ± 6.5) RECEIVED GELATIN MATRIX-THROMBIN SOLUTION (FLOSEAL; MATRIX GROUP). DURING THE PROCEDURE, ONCE THE SOURCE OF BLEEDING HAD BEEN IDENTIFIED, IN THE STANDARD GROUP, PROLENE 4-0 STITCHES WAS USED. IN THE STANDARD GROUP, REPORTED COMPLICATION INCLUDED BLEEDING (N-2) WHICH REQUIRED SURGICAL REVISION. IT WAS REPORTED THAT FOLLOWING CONTROL OF INTRAOPERATIVE BLEEDING, SUTURES MAY BE USED AS A PRECAUTION FOR VESSEL REPAIR. IT WAS CONCLUDED THAT FLOSEAL SOLUTION IS AN EFFECTIVE TOOL FOR CONTROLLING MAJOR BLEEDING AFTER INTRAOPERATIVE PA INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524208 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention