BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7635464 · Received June 25, 2018

    Report

    Report Number
    2210968-2018-73760
    Event Type
    Injury
    Date Received
    June 25, 2018
    Report Date
    June 1, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: ANN THORAC SURG. 2014; 97: 666 72. PLEASE SEE REFERENCED ARTICLE ATTACHED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: MODIFIED SINGLE-PATCH COMPARED WITH TWO-PATCH REPAIR OF COMPLETE ATRIOVENTRICULAR SEPTAL DEFECT AUTHORS: SHINYA UGAKI, MD, PHD; NEE S. KHOO, MBCHB; DAVID B. ROSS, MD; IVAN M. REBEYKA, MD; IAN ADATIA, MBCHB. CITATION: ANN THORAC SURG. 2014; 97: 666 72. DOI: HTTP://DX.DOI.ORG/10.1016/J.ATHORACSUR.2013.09.084 . THE AUTHORS COMPARED THE OUTCOMES OF MODIFIED SINGLE-PATCH AND TWO-PATCH SURGICAL REPAIR OF COMPLETE ATRIOVENTRICULAR SEPTAL DEFECT (CAVSD) ON LEFT VENTRICULAR OUTFLOW TRACT (LVOT) DIAMETER AND ON LEFT ATRIOVENTRICULAR VALVE (LAVV) COAPTATION. THE AUTHORS REVIEWED RETROSPECTIVELY POST-OPERATIVE 2-DIMENSIONAL ECHOCARDIOGRAMS OF ALL CAVSD PATIENTS WHO UNDERWENT MODIFIED SINGLE-PATCH OR TWO-PATCH REPAIR BETWEEN 2005 AND 2011. A TOTAL OF 51 PATIENTS (16 MALE INFANTS AND 35 FEMALE INFANTS) UNDERWENT CAVSD REPAIR AT A MEDIAN AGE OF 4 MONTHS (AGE RANGE: 1 TO 9 MONTHS). OF WHICH 29 PATIENTS UNDERWENT SINGLE-PATCH WHILE 22 PATIENTS UNDERWENT THE TWO-PATCH TECHNIQUE. DURING THE SURGICAL PROCEDURE FOR THE MODIFIED SINGLE-PATCH TECHNIQUE, THE ZONE OF APPOSITION (LAVV CLEFT) WAS CLOSED WITH A SERIES OF INTERRUPTED PROLENE SUTURES. THEN, A SERIES OF HORIZONTAL MATTRESS PLEDGETED PROLENE SUTURES WAS PASSED THROUGH THE RIGHT SIDE OF THE VENTRICULAR SEPTAL CREST AND THROUGH THE BASE OF THE LAVV BEFORE BEING PASSED THROUGH A TRIMMED BOVINE PERICARDIUM. THE SUTURES WERE THEN TIED TO CLOSE THE VENTRICULAR COMPONENT, WITH THE LAVV SANDWICHED BETWEEN THE BOVINE PATCH AND THE CREST OF THE VENTRICULAR SEPTUM. THE BOVINE PERICARDIAL PATCH WAS SECURED TO THE RIM OF THE OSTIUM PRIMUM DEFECT WITH CONTINUOUS PROLENE SUTURE, LEAVING THE CORONARY SINUS DRAINING NORMALLY TO THE RIGHT ATRIUM. IN THE TWO-PATCH REPAIR TECHNIQUE, THE ZONE OF APPOSITION (LAVV CLEFT) WAS APPROXIMATED WITH INTERRUPTED PROLENE SUTURES BEFORE THE ATRIAL SEPTAL DEFECT WAS CLOSED. IN THE MODIFIED SINGLE-PATCH TECHNIQUE, REPORTED COMPLICATIONS INVOLVED 1 PATIENT WITH SIGNIFICANT LAVV AND A SMALL RESIDUAL VSD DUE TO A TEAR IN THE BASE OF THE SUPERIOR LEAFLET ADJACENT TO THE PATCH WHICH REQUIRED RE-OPERATION. IT WAS CONCLUDED THAT THE MODIFIED SINGLE-PATCH REPAIR WAS PERFORMED WITH SIGNIFICANTLY SHORTER BYPASS TIME AND MYOCARDIAL ISCHEMIC TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475318 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention