BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYFLEX STENT

    MDR report key: 853635 · Received May 22, 2007

    Report

    Report Number
    6000146-2007-00024
    Event Type
    Injury
    Date Received
    May 22, 2007
    Report Date
    April 25, 2007
    Manufacturer
    RUSCH GMBH GERMANY/TELEFLEX MEDICAL
    Product Code
    NYT
    PMA / PMN Number
    K013266
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DEVICE USED IS UNK; CONSEQUENTLY, THE MANUFACTURE DATE OF THE DEVICE IS UNK. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. THE APRIL 2007 15-MONTH POLYFLEX AIRWAY STENT COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO ADVERSE TREND WAS NOTED AND NO DATA POINT EXCEEDED THE COMPLAINT ALERT LIMIT. PLEASE NOTE ASSOCIATED MEDWATCH REPORT 6000416-2007-00026.

    Description of Event or Problem · 1

    NOTE: THE DATE OF EVENT IS UNK. ON APRIL 25, 2007, A BOSTON SCIENTIFIC CORPORATION EMPLOYEE BECAME AWARE OF A CLINICAL STUDY ARTICLE, "PERFORMANCE OF A SELF-EXPANDING SILICONE STENT IN PALLIATION OF BENIGN AIRWAY CONDITIONS", PUBLISHED IN CHEST (AMERICAN COLLEGE OF CHEST PHYSICIANS/CHEST 2006;130;1419-1423). THE STUDY CONDUCTED WAS A RETROSPECTIVE REVIEW OF THE MEDICAL RECORDS OF ALL PATIENTS IN WHOM A POLYFLEX STENT WAS USED TO TREAT A SYMPTOMATIC BENIGN AIRWAY CONDITION. THE FOLLOWING INFORMATION WAS DERIVED FROM THAT ARTICLE. CASE # 9 - RECORD 2 OF 2. SEVEN DAYS AFTER A POLYFLEX STENT PLACEMENT IN LEFT MAIN BRONCHUS OF A MALE PATIENT, THERE WAS A "MUCOUS PLUG." THE STENT WAS REPLACED WITH ANOTHER SAME DEVICE. "ALL PATIENTS WITH STENT-RELATED COMPLICATIONS HAD INCREASED SHORTNESS OF BREATH AND COUGH." SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN THE PATIENT'S CURRENT STATUS TO NO AVAIL. "A CT SCAN OF THE CHEST AIDED THE SELECTION OF A STENT WITH AN APPROPRIATE DIAMETER. STENTS WERE OVERSIZED BY 1 TO 2 MM COMPARED TO THE DESIRED LUMEN; THE LATTER WAS BASED ON THE PROXIMAL EXTENT OF THE ABNORMALITY. THE LENGTH OF THE STENT WAS BASED ON A DIRECT MEASUREMENT OF THE OBSTRUCTED SEGMENT USING A FLEXIBLE BRONCHOSCOPE. DEPENDING ON THE DEGREE AND TYPE OF THE STENOSIS, DILATION OF THE INVOLVED AIRWAY WAS PERFORMED EITHER USING A RIGID BRONCHOSCOPE (RB) OR A BALLOON PRIOR TO THE STENT PLACEMENT. ENDOBRONCHIAL ELECTROSURGERY WAS USED TO CUT CONCENTRIC-TYPE, WEB-LIKE STENOSIS, IF INDICATED. ALL STENTS WERE PLACED VIA AN RB OR A SUSPENSION LARYNGOSCOPE UNDER GENERAL ANESTHESIA AND FLUOROSCOPIC GUIDANCE USING A TEAM APPROACH." "IN ALL PATIENTS WHO HAD UNDERGONE LTR WITH ANASTOMOTIC STENOSIS, THE STENT FAILED DUE TO MIGRATION. DUE TO THE DISCREPANCY BETWEEN THE RECIPIENT AND THE DONOR AIRWAY CALIBER, THESE PATIENTS PRESENTED WITH A FUNNEL-SHAPED ANATOMY, WHICH POSED A SIGNIFICANT CHALLENGE DURING THE STENT PLACEMENT AND CONTRIBUTED TO THE MIGRATION. THE SHORT DISTANCE BETWEEN THE ANASTOMOSIS AND THE SECONDARY CARINA OFTEN LED TO OBSTRUCTION OF A LOBAR OR SEGMENTAL BRONCHUS BY THIS STENT AS WELL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYFLEX STENT NYT RUSCH GMBH GERMANY/TELEFLEX MEDICAL M00570070 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention ALBUTEROL AEROSOL TREATMENT 4X PER DAY| 1ML OF 20% NEBULIZED ACETYLCYSTEINE