BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7681371 · Received July 12, 2018

    Report

    Report Number
    2210968-2018-74282
    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 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. 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: ANN VASC SURG. 2016; 32: 131.E7¿131.E9. DOI: HTTP://DX.DOI.ORG/10.1016/J.AVSG.2015.10.014. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: ABDOMINAL AORTIC THROMBOSIS IN A HEALTHY NEONATE AUTHOR: MARKO BOGOVIC, DINO PAPES, DAVORIN MITAR, RANKO SMILJANIC, SUZANNA SRSEN-MEDANCIC, STANKO CAVAR, ANKO ANTABAK AND TOMISLAV LUETIC, ZAGREB, CROATIA CITATION: ANN VASC SURG. 2016; 32: 131.E7¿131.E9. DOI: HTTP://DX.DOI.ORG/10.1016/J.AVSG.2015.10.014. THE AUTHORS PRESENTED A COMPLICATED CASE OF AN OTHERWISE HEALTHY NEONATE WHO DEVELOPED THROMBOSIS OF THE ABDOMINAL AORTA WITH SUBSEQUENT RENAL FAILURE AND REQUIRED MULTIMODAL TREATMENT. THE PATIENT WAS A 3.57-KG NEONATE BORN FROM NORMAL PREGNANCY AT TERM BY VAGINAL DELIVERY. ON THE THIRD DAY, HE DEVELOPED LOWER-EXTREMITY CYANOSIS FOLLOWED BY RESPIRATORY DISTRESS, ANURIA, AND DIMINISHED FEMORAL PULSES. FURTHER EXAMINATION REVEALED THROMBOSIS OF THE ABDOMINAL AORTA WITH SUBSEQUENT RENAL FAILURE. BECAUSE OF THE WORSENING CONDITION OF THE PATIENT, THE DECISION TO UNDERGO OPEN THROMBECTOMY WAS MADE. DURING THE PROCEDURE, A 5-MM TRANSVERSE ARTERIOTOMY WAS MADE IN THE SEGMENT BETWEEN INFERIOR MESENTERIC ARTERY AND BIFURCATION FOLLOWED BY PROXIMAL AND DISTAL THROMBECTOMY USING FOGARTY CATHETER. GOOD INFLOW AND BACKFLOW WERE OBTAINED, AND ARTERIOTOMY WAS CLOSED WITH PROLENE 7-0 SUTURE. THE FOLLOWING DAY CONTROL DOPPLER SHOWED RECURRENT THROMBOTIC OCCLUSION IN THE SAME EXTENT AS PREVIOUS. BECAUSE OF THE WORSENING CONDITION OF THE PATIENT, ALTEPLASE 0.5 MG/KG/HR INFUSION WAS GIVEN DESPITE THE HIGH RISK OF BLEEDING. AFTER 6 HOURS, DOPPLER SHOWED RECANALIZATION OF THE AORTA, ALTEPLASE WAS DISCONTINUED AND INTRAVENOUS HEPARIN 28 UNITS/KG/HR WAS GIVEN AND FURTHER TITRATED TO ACTIVATED PARTIAL THROMBOPLASTIN TIME BETWEEN 50 AND 80 SEC. AFTER 5 DAYS, ANTICOAGULATION WAS CONVERTED TO LOW-MOLECULAR-WEIGHT HEPARIN (ENOXAPARIN 1 MG/KG SUBCUTANEOUSLY EVERY 12 HOURS). THE PATIENT WAS DISCHARGED AFTER 5 WEEKS, AND FURTHERMORE, COURSE WAS UNEVENTFUL. IT WAS CONCLUDED THAT THE TREATMENT OF THROMBOSIS OF THE ABDOMINAL AORTA IN A NEONATE SHOULD BE CONSIDERED ON A CASE-BY-CASE BASIS AND MAY INCLUDE SEVERAL TREATMENT OPTIONS OR THEIR COMBINATIONS IN COMPLICATED CASES. IF OPEN THROMBECTOMY IS PERFORMED, RETROPERITONEAL APPROACH SHOULD BE PREFERRED BECAUSE IT ALLOWS FOR EASY INSTITUTION OF PERITONEAL DIALYSIS SHOULD THE NEED ARISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525186 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention