BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 3011443 · Received March 19, 2013

    Report

    Report Number
    2024168-2013-01582
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 22, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION.(B)(4) - NO PRE-DILATATION; INDICATION FOR USE; AGAINST RESISTANCE.IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THAT THE RX MINI VISION INSTRUCTIONS FOR USE (IFU) STATES: PRE-DILATE THE LESION WITH A PTCA CATHETER. THE RX MINI VISION INDICATION FOR USE SECTION LISTED IN THE IFU STATES: THE MULTI-LINK MINI VISION RX AND MULTI-LINK MINI VISION OTW CORONARY STENT SYSTEMS ARE INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH ABRUPT OR THREATENED ABRUPT CLOSURE WITH FAILED INTERVENTIONAL THERAPY OF DE NOVO AND RESTENOTIC NATIVE CORONARY ARTERY LESIONS, OR PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO NATIVE CORONARY ARTERY. ADDITIONALLY, THE IFU WARNS: SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING LESION ACCESS OR DELIVERY SYSTEM REMOVAL, THE ENTIRE GUIDING CATHETER AND STENT SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. APPLYING EXCESSIVE FORCE TO THE STENT DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND DELIVERY SYSTEM COMPONENTS. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE SOMETIME DURING THE WEEK OF (B)(6) 2013, TWO UNSPECIFIED STENTS WERE IMPLANTED; ONE IN THE NON-CALCIFIED/NON-TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD) AND ONE IN THE DIAGONAL ARTERY. ON (B)(6) 2013, DURING ANOTHER PROCEDURE, THE PHYSICIAN NOTICED A SMALL DISSECTION IN THE DIAGONAL ARTERY AND MADE THE DECISION TO TREAT THE DISSECTION USING A 2.25X15 RX MINI VISION STENT. PRE-DILATATION WAS NOT PERFORMED AND THE STENT SYSTEM WAS ADVANCED INTO THE VESSEL. PRIOR TO THE LESION, BUT AT THE POINT OF THE PREVIOUSLY IMPLANTED STENT, RESISTANCE WAS FELT AND SOME FORCE WAS APPLIED TO THE STENT SYSTEM. IT WAS NOT POSSIBLE TO ADVANCE THE STENT SYSTEM BEYOND THE PREVIOUSLY IMPLANTED STENT; THEREFORE AN ATTEMPT WAS MADE TO WITHDRAW THE STENT SYSTEM. DURING REMOVAL, RESISTANCE WAS FELT, FORCE WAS APPLIED, AND THE STENT DISLODGED FROM THE BALLOON. AN UNSUCCESSFUL ATTEMPT WAS MADE TO RETRIEVE THE STENT USING A BALLOON; THEREFORE, THE STENT WAS APPOSED TO THE PROXIMAL SEGMENT OF THE LAD USING A 3.0X15 BALLOON. THE TARGET LESION WAS NOT TREATED AND THE PROCEDURE WAS ABORTED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. CURRENTLY, THERE IS NO ADDITIONAL PROCEDURE PLANNED TO TREAT THE TARGET LESION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114960 MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 2042041

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention