BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESILLION COCR CORONARY STENT ON RX SYSTEM

    MDR report key: 2801309 · Received October 17, 2012

    Report

    Report Number
    9710284-2012-00003
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    July 28, 2012
    Report Date
    July 30, 2012
    Manufacturer
    MEDINOL LTD.
    Product Code
    MAF
    PMA / PMN Number
    P100012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS SUMMARY: RETURNED PRODUCT RECEIVED WITHOUT A STENT (DISLODGED). DELIVERY SYSTEM APPEARED NORMAL EXCEPT FOR A KINK NEAR THE PROXIMAL MARKER. THESE USUALLY RESULT FROM POST PROCEDURE HANDLING. A SHIPPING MANDREL EASILY PASSED THROUGH THE RAPID EXCHANGE (RE) LUMEN. SOLUTION RESIDUES OBSERVED IN THE SYSTEM. EVIDENCE OF BALLOON INFLATION; APPEARANCE OF BALLOON CONSISTENT WITH THAT OF A BALLOON THAT UNDERWENT INFLATION/DEFLATION AND EXHIBITED NORMAL POST INFLATION/DEFLATION TRI-FOLDING. RESIDUAL STENT IMPRINTING ON THE BALLOON WAS WELL DEFINED AND PROPERLY LOCATED, WHICH INDICATES THAT THE STENT DISLODGMENT AND DEFORMATION WERE POST PRODUCTION EVENTS. DELIVERY SYSTEM TIP IN GOOD CONDITION. SYSTEM BALLOON, RE-PORT AND HUB DID NOT EXHIBIT ANY ANOMALIES. RESULTS OF THIS STUDY, TOGETHER WITH THE CUSTOMER REPORT INDICATE THAT THE RETURNED PRODUCT WAS SUPPLIED MEETING SPECIFICATIONS. CONTROLS IN PLACE PREVENT DEFORMED OR DAMAGED PRODUCTS FROM BEING RELEASED. TRACKING DIFFICULTY/FAILURE TO CROSS IS A KNOWN PROCEDURAL OCCURRENCE COMMONLY RELATED TO PATIENT ANATOMY, VESSEL AND LESION DISPOSITION AND COMPOSITION, OPERATOR TECHNIQUE, AND APPROPRIATE DEVICE SELECTION. THESE ISSUES ARE LIKELY THE MAIN CONTRIBUTING FACTORS IN THIS EVENT. NO CONCLUSIVE DETERMINATION CAN BE MADE AS TO THE SEQUENCE OF EVENTS OR CIRCUMSTANCES THAT BROUGHT ABOUT THE STENT DISLODGEMENT, BUT THE REPEATED RE-ENTRY INTO THE GUIDING CATHETER (CONTRARY TO SECTION 5.3 OF THE IFU, STENT/SYSTEM REMOVAL- PRECAUTIONS) MAY HAVE CONTRIBUTED TO SAME. THE RESULTS OF THIS INVESTIGATION DID NOT REVEAL ANY RELATION BETWEEN THE MEDINOL MANUFACTURING PROCESS AND THE FAILURES EXPERIENCED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE COMPLAINT WAS INITIALLY REPORTED AS A FAILURE TO CROSS. AFTER MORE INFORMATION WAS RECEIVED ((B)(4)), ¿TRACKING DIFFICULTY¿ WAS ADDED TO THE COMPLAINT. THE ADDITIONAL DATA INDICATED THE PATIENT HAD A DOUBLE VESSEL DISEASE (LAD, LCX). THE TARGET LESION IN THE LAD WAS DESCRIBED AS CALCIFIED AND TORTUOUS, WITH 95% STENOSIS. AFTER PRE-DILATION THE LESION HAD 50% STENOSIS. THE VESSEL IN THE LCX WAS DESCRIBED AS CALCIFIED, WITH 90% STENOSIS. AFTER PRE-DILATION THE LESION HAD 60% STENOSIS. THE STENT WAS FIRST INTRODUCED TO LAD WHERE IT DIDN¿T CROSS THE LESION, AND THEN IT WAS RETRIEVED AND INSERTED IN LCX, WHERE IT BECAME DISLODGED AT AN INITIAL PRESSURE OF 7 ATM. AFTER RECEIVING FURTHER DATA ((B)(4)), THE COMPLAINT WAS REVISED AGAIN TO INCLUDE ¿STENT DISLODGEMENT¿. THE STENT DELIVERY SYSTEM WITH THE STENT STILL INTACT, WAS TWICE RETRIEVED BACK INTO THE GUIDE CATHETER. THE BALLOON INFLATED PROXIMALLY FIRST; WHEN IT REACHED 7 ATM, THE STENT DISLODGED, ADVANCED INSIDE THE ARTERY AND WAS IMPLANTED DISTALLY OUTSIDE THE LESION. IT REMAINED IN THE PATIENT AND THE PROCEDURE WAS ACCOMPLISHED WITH A DRIVER COBALT CHROMIUM STENT. NO INJURY TO THE PATIENT WAS REPORTED AS A RESULT OF THE DISLODGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESILLION COCR CORONARY STENT ON RX SYSTEM CORONARY SDS/STENTS MAF MEDINOL LTD. PRE PLUS 2.75 X 33 PL000536

    Patients

    Seq Age Sex Outcome Treatment
    1