BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    MDR report key: 2478408 · Received February 21, 2012

    Report

    Report Number
    3005325609-2012-00003
    Event Type
    Malfunction
    Date Received
    February 21, 2012
    Date of Event
    January 24, 2012
    Report Date
    January 25, 2012
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K111766
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). WHERE THE DEVICE HOLDS THE CE MARK FOR THE PERIPHERAL VASCULAR INDICATION. ANGIOGRAPHS OF THE PROCEDURE WERE RECEIVED AND REVIEWED. THE CAUSE OF THE TIP DISLODGEMENT IS UNK, HOWEVER, AFTER REVIEWING THE ANGIOGRAMS, TWO POSSIBILITIES WERE MADE: BASED ON THE POSITION OF THE PROXIMAL END OF THE STENT, THERE WAS INSUFFICIENT ROOM FOR THE DELIVERY SYSTEM AND/OR THE INTRODUCER ON THE CONTRALATERAL SIDE OF THE AORTIC BIFURCATION. IF THE DISTAL END OF THE INTRODUCER REMAINED IN THE BIFURCATION AREA INSTEAD OF BEING PULLED DOWN INTO THE RIGHT ILIAC THEN THE EDGE OF THE INTRODUCER WOULD HAVE BEEN EXPOSED AND THE DELIVERY SYSTEM WOULD HAVE BEEN PULLED OVER THE EDGE IN A NEARLY PERPENDICULAR ANGLE; OR THE MANUAL ADJUSTING OF THE TUOHY-BORST VALVE OF THE INTRODUCER WAS TOO TIGHT AND HELD THE TIP FROM PASSING THROUGH THE VALVE. THIS IS THE SECOND EVENT REPORTED FOR THE 6FR SUPERA VERITAS STENT DELIVERY SYSTEM. A CAPA FOR THIS EVENT TYPE AS BEEN OPENED.

    Description of Event or Problem · 1

    THE PT WAS ADMITTED FOR PAIN AND WAS FOUND TO HAVE OCCLUSION OF THE RIGHT PROXIMAL EXTERNAL ILIAC ARTERY. USING CROSS OVER TECHNIQUE FROM THE LEFT VIA THE COMMON FEMORAL ARTERY, THE PHYSICIAN PLACED A 6 MM X 150 MM IN THE RIGHT DISTAL EXTERNAL ILIAC ARTERY FIRST WITH NO PROBLEM. THE PHYSICIAN THEN IMPLANTED THE SECOND STENT ((B)(4)) INTO THE RIGHT SFA. THE STENT DEPLOYED CORRECTLY AND THE DRIVER WAS DRAWN BACK AND THE SYSTEM LOCKED. WHEN THE CATHETER WAS WITHDRAWN OUT OF THE SHEATH THERE WAS NO TIP ON THE END. THE SHEATH WAS EXCHANGED AND FLUSHED AND THE TIP WAS NOT PRESENT. IMAGING SHOWED THAT THE TIP HAD TRAVELED DOWN INTO THE LOWER TIBIAL ARTERY CAUSING PAIN TO THE PT AND THE RIGHT FOOT TO BE WHITE IN COLOR. THE VASCULAR SURGEON AND A CONSULTANT RADIOLOGIST MADE A DECISION TO RETRIEVE THE TIP WITH A SNARE DEVICE WHICH THEY DID IMMEDIATELY AND THE PT WAS GIVEN MORPHINE. FOLLOWING THIS INTERVENTION, A THROMBI FORMED IN BOTH THE STENTS AND DISTALLY IN THE ANTERIOR TIBIAL ARTERY EVEN THOUGH ANTICOAGULANT THERAPY WAS GIVEN. A THROMBECTOMY AND PLACEMENT OF ANOTHER STENT WAS PERFORMED. IT WAS REPORTED THAT PT IS DOING WELL. THIS EVENT OCCURRED IN EUROPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. SE-05-200-120-6F 01137064

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R 0.18" GUIDEWIRE| 6FR INTRODUCER SHEATH| COOK'S FLEXOR TUOHY-BORST SIDE - ARM INTRODUCER