BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 2861714 · Received December 7, 2012

    Report

    Report Number
    2024168-2012-07724
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 14, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). GUIDE WIRE: 300 CM PROWATER, 300 CM WHISPER EXTRA SUPPORT; GUIDE CATHETER: JR4, 6 FRENCH AL1, 6 FRENCH GUIDE LINER; SHEATH: 6 FRENCH. RE-INSERTION OF THE SDS AFTER REMOVAL FROM THE ANATOMY. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. THE REPORTED FAILURE TO ADVANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. THE REPORTED STENT DISLODGEMENT WAS CONFIRMED VIA RETURNED DEVICE AND WAS MOST LIKELY RELATED TO THE MULTIPLE ATTEMPTS TO ADVANCE THE CATHETER. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THAT THE MULTILINK VISION INSTRUCTIONS FOR USE (IFU), STATES: AN UNEXPANDED STENT MAY BE RETRACTED INTO THE GUIDING CATHETER ONE TIME ONLY. SUBSEQUENT MOVEMENT IN AND OUT THROUGH THE DISTAL END OF THE GUIDING CATHETER SHOULD NOT BE PERFORMED, AS THE STENT MAY BE DAMAGED WHEN RETRACTING THE UNDEPLOYED STENT BACK INTO THE GUIDING CATHETER. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 2.5X15 MINI VISION STENT DELIVERY SYSTEM (SDS) WAS UNABLE TO CROSS THE PREDILATED, 95% STENOSED, HEAVILY CALCIFIED TARGET LESION IN THE MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED AGAIN, BUT THE SDS WAS STILL UNABLE TO CROSS THE LESION. THE PROWATER GUIDEWIRE WAS REPLACED WITH A WHISPER EXTRA SUPPORT GUIDEWIRE, BUT THE SDS WAS STILL UNABLE TO CROSS THE LESION. A CO-AXIAL, NON-ABBOTT GUIDE CATHETER EXTENSION WAS ADVANCED INTO THE TARGET LESION, WHICH ALLOWED THE SDS TO REACH THE RCA; HOWEVER, THE STENT DISLODGED INSIDE THE GUIDE CATHETER EXTENSION. THE GUIDE CATHETER, GUIDE CATHETER EXTENSION, GUIDE WIRE, SDS AND DISLODGED STENT WERE REMOVED TOGETHER AS A SINGLE UNIT. THE DISLODGED STENT HAD REMAINED INSIDE THE GUIDE CATHETER EXTENSION AND WAS SUCCESSFULLY REMOVED FROM THE ANATOMY. THE GUIDE CATHETER EXTENSION WAS RE-ADVANCED INTO THE TARGET LESION AND A 2.5X18 MINI VISION STENT WAS DEPLOYED AT 10 ATMOSPHERES IN THE TARGET LESION WITHOUT FURTHER INCIDENT. THERE WAS 0% RESIDUAL STENOSIS WITH TIMI 3 FLOW INTO THE DISTAL VESSEL. THERE WAS NO ADVERSE PATIENT EFFECT. THERE WAS NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED MEDWATCH, ADDITIONAL INFORMATION RECEIVED: THE CATHETERIZATION LAB TECHNICIAN WHO WAS ASSISTING THE PHYSICIAN, REPORTED THAT THE TECHNICIAN DOES NOT FEEL THAT THE STENT DISLODGMENT WAS DUE TO A DEVICE MALFUNCTION, BUT WAS DUE TO THE RE-INSERTION OF THE STENT DELIVERY SYSTEM INTO HEAVILY CALCIFIED AND TIGHT LESION. THE TECHNICIAN FURTHER REPORTED THAT THE STENT DELIVERY SYSTEM HAD BEEN RE-INSERTED INTO THE PATIENT FOR THE THIRD TIME WHEN THE STENT DISLODGED, BUT REMAINED IN THE NON-ABBOTT GUIDE CATHETER EXTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 2022341

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR CONCOMITANT MEDICAL DEVICES