BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRASTENT LD

    MDR report key: 5745764 · Received June 23, 2016

    Report

    Report Number
    2183870-2016-00438
    Event Type
    Injury
    Date Received
    June 23, 2016
    Date of Event
    June 1, 2015
    Report Date
    May 24, 2016
    Manufacturer
    COVIDIEN
    Product Code
    FGE
    PMA / PMN Number
    K020528
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AVERAGE AGE, MAJORITY GENDER. DATE OF PUBLICATION JOURNAL TITLE: TRANSCATHETER PULMONARY VALVE IMPLANTATION IN PATIENTS WITH RIGHT VENTRICULAR OUTFLOW TRACT DYSFUNCTION: EARLY AND MID-TERM RESULTS BIERNA CKA, ET AL. VOL.27, NO. 6, JUNE 2016. CONTRADICTION USE: INDICATED FOR USE IN OCCLUSIONS, LESIONS AT HIGH RISK FOR ABRUPT CLOSURE OR THREATENED CLOSURE FOLLOWING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OR LESIONS BELIEVED TO BE AT HIGH RISK OF RESTENOSIS FOLLOWING PTA IN THE COMMON ILIAC, EXTERNAL ILIAC, OR SUBCLAVIAN ARTERIES.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ABSTRACT: OBJECTIVE. THE AIM OF THIS STUDY WAS TO DETERMINE EARLY AND LONG-TERM RESULTS AFTER TRANSCATHETER PULMONARY VALVE IMPLANTATION (TPVI) PERFORMED WITH THE USE OF MEDTRONIC MELODY AND EDWARDS SAPIEN VALVES IN PATIENTS WITH FULL CONDUIT OR PATCHED RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) DYSFUNCTION. METHODS AND RESULTS. THE STUDY COMPRISED 40 CONSECUTIVE PATIENTS (FULL CONDUIT, N = 25; RVOT PATCH, N = 15) WHO UNDERWENT TPVI BETWEEN DECEMBER 2008 AND APRIL 2012. TPVI WAS SUCCESSFULLY PERFORMED IN 37 PATIENTS (92.5%). THE GRADIENT ACROSS RVOT DECREASED FROM 82.96 +/- 37.90 MM HG TO 34.33 +/- 22.2 MM HG ON THE DAY FOLLOWING TPVI (P<(><<)>.001) AND REMAINED LOW AT FOLLOW-UP OF 20.4 +/- 11.4 MONTHS. THE COMPETENCY OF THE PULMONARY VALVE WAS RESTORED AND MAINTAINED DURING THE FOLLOW-UP. NEW YORK HEART ASSOCIATION CLASS, RIGHT VENTRICLE END-DIASTOLIC VOLUME, AND RIGHT VENTRICULAR EJECTION FRACTION ALL IMPROVED AS SOON AS 1 MONTH AFTER THE PROCEDURE. INFECTIVE ENDOCARDITIS WAS OBSERVED IN 4 PATIENTS (1 DIED). FOUR PATIENTS UNDERWENT SURGERIES DUE TO ENDOCARDITIS, HOMOGRAFT RUPTURE, STENT MIGRATION, AND EARLY VALVE COMPRESSION. CONCLUSION. TPVI MAY BE PERFORMED SAFELY AND EFFECTIVELY IN PATIENTS WITH RIGHT VENTRICLE-PULMONARY ARTERY CONDUIT AND IN SELECTED PATIENTS WITH PATCHED RVOT. THE STUDY POPULATION CONSISTED OF 40 CONSECUTIVE PATIENTS (AGE RANGE, 13 TO 58 YEARS; MEAN AGE, 25.4 &#6200;.7 YEARS; 22 MALES) WHO UNDERWENT TPVI AT ONE CENTER BETWEEN DECEMBER 2008 AND APRIL 2012. PATIENT CHARACTERISTICS ARE SUMMARIZED IN TABLE 1. THE FULL RIGHT VENTRICLE (RV) TO PULMONARY ARTERY (PA) CONDUIT WAS IMPLANTED IN 25 PATIENTS (62.5%); 15 PATIENTS (37.5%) HAD THE RVOT EXTENDED WITH THE PATCH. ALL PROCEDURES WERE PERFORMED UNDER GENERAL ANESTHESIA WITH ENDOTRACHEAL INTUBATION. THE FEMORAL OR JUGULAR VEIN (3 CASES) WAS USED FOR ACCESS. BEFORE VALVE IMPLANTATION, ALL PATIENTS UNDERWENT ROUTINE PRESTENTING OF THE TARGET SITE WITH THE INTRASTENT MAX LD BARE-METAL STENT (EV3 ENDOVASCULAR). IN 5 CASES, PRESTENTING AND VALVE IMPLANTATION WERE CARRIED OUT SEPARATELY. IN THESE PATIENTS, THERE WAS NO WAIST AFTER PRESTENTING THE BORDERLINE-SIZE OUTFLOW TRACT, AND THEREFORE IT WAS DECIDED TO DELAY THE VALVE IMPLANTATION FOR 2 MONTHS IN ORDER TO ALLOW PROPER STENT FIXATION AS A RESULT OF TISSUE INGROWTH. THE MELODY VALVE, WHICH WAS MOUNTED ON A 18, 20, OR 22 MM ENSEMBLE DELIVERY SYSTEM (MEDTRONIC, INC), WAS INTRODUCED AND DEPLOYED INTO THE PREIMPLANTED STENT. TWO MAJOR PROCEDURAL COMPLICATIONS OCCURRED, BOTH DURING THE PRESTENTING PROCEDURE: RUPTURE OF THE CALCIFIED AORTIC HOMOGRAFT11 AND STENT DISLODGMENT. WE ALSO OBSERVED AN EARLY STENT COMPRESSION BY THE CALCIFIED AORTIC MONOCUSP VALVE WITH THE RV-PA GRADIENT. INCREASE FROM 23 MM HG TO 120 MM HG THE DAY AFTER SUCCESSFUL MM IMPLANTATION.13 ALL 3 PATIENTS UNDERWENT SURGERY WITHOUT COMPLICATIONS. NONE OF THE SURGICAL REVISIONS LED TO DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399054 INTRASTENT LD CATHETER, BILIARY, DIAGNOSTIC FGE COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention