BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 2387323 · Received December 22, 2011

    Report

    Report Number
    2024168-2011-08815
    Event Type
    Injury
    Date Received
    December 22, 2011
    Date of Event
    November 18, 2011
    Report Date
    November 28, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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. GUIDE WIRE: 0.014 RUNTHROUGH; FIELDER FC; GUIDE CATH: 6FR, IL 3.5; SHEATH: 5F. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED MULTI-LINK MINI VISION STENT DELIVERY SYSTEM (SDS) NOTED BLOOD IN THE GUIDE WIRE LUMEN AND ON THE BALLOON AND SHAFT AND NO CONTRAST VISIBLE, WHICH IS CONSISTENT WITH THE REPORTED INFORMATION THAT THE DEVICE WAS ADVANCED IN THE ANATOMY. THERE WERE MULTIPLE KINKS THROUGH OUT THE ENTIRE LENGTH OF THE HYPOTUBE, WHICH IS CONSISTENT WITH HANDLING DURING PACKING POST-PROCEDURE TO RETURN FOR ANALYSIS. THE DISTAL TIP WAS MEASURED AND MET MANUFACTURING CRITERIA. THE DISLODGED STENT IMPLANT WAS NOT RETURNED. THERE WERE CRIMP MARKS ON THE TIGHTLY-FOLDED BALLOON BETWEEN THE MARKERS, WHICH SUGGESTS THAT THE STENT WAS PROPERLY AND SECURELY CRIMPED DURING MANUFACTURING. A CINE IMAGE WAS RECEIVED AND REVIEWED BY AN ABBOTT VASCULAR CLINICAL REPRESENTATIVE. THE CINE IMAGE REVEALED THAT THE GUIDE CATHETER WAS NOT ENGAGED IN THE OSTIUM, AND THE OUTLINE OF THE LEFT MAIN (LM) AND THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) LUMEN IS NOT WELL DEFINED AND HAS A HAZY APPEARANCE. ALTHOUGH THE RESOLUTION OF THE IMAGE IS NOT GOOD ENOUGH TO IDENTIFY A DISTINCT DISSECTION PLANE, THE HAZINESS IN THE LM AND PROXIMAL LAD SUGGEST A DISSECTION. BASED ON THE REPORTED INFORMATION, THE REPORTED COMPLAINT APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THIS SPECIFIC CASE. AS MULTIPLE DEVICES HAD DIFFICULTY ADVANCING AND OTHER STENT DEVICES DISLODGED IN THE TARGET VESSEL, THE CHALLENGING ANATOMY LIKELY CONTRIBUTED TO THE REPORTED FAILURE TO ADVANCE AND STENT DAMAGE. IN ADDITION TO THE CHALLENGING ANATOMY, INTERACTION OR MISALIGNMENT WITH THE GUIDING CATHETER TIP ALSO LIKELY CONTRIBUTED TO THE REPORTED DIFFICULT TO REMOVE AND SUBSEQUENT STENT DISLODGEMENT. THESE DIFFICULTIES AND STENT DAMAGE LIKELY CONTRIBUTED TO THE REPORTED DISSECTION. A REVIEW OF THE DEVICE LOT HISTORY RECORD REVEALED NO NONCONFORMING MATERIAL RECORDS, INDICATING THAT ALL LOT RELEASE TESTING RESULTS MET SPECIFICATION. A QUERY OF THE COMPLAINT-HANDLING DATABASE FOR THIS LOT FOUND NO OTHER INCIDENTS REPORTED FOR FAILURE TO ADVANCE/PHYSICAL RESISTANCE, STENT DISLODGEMENT/LOOSE OR DIFFICULT TO REMOVE FROM THE VESSEL. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. DURING MANUFACTURING, ALL STENT DELIVERY SYSTEMS ARE VISUALLY INSPECTED FOR STENT DAMAGE AND PROPER STENT PLACEMENT AS WELL AS DIMENSIONALLY CHECKED FOR PROPER CRIMPED STENT OUTER DIAMETER. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED PRIOR TO LOT RELEASE TO VERIFY CRIMPED STENT OUTER DIAMETER, STENT MOVEMENT AND STENT DISLODGEMENT FORCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THREE VESSEL DISEASE PROCEDURE THE STENT IMPLANT BECAME STUCK AND A DISSECTION WAS NOTED DURING USE OF THE MINIVISION STENT DELIVERY SYSTEM. A 6 FR IL 3.5 GUIDING CATHETER WITH A 0.014 NON-ABBOTT GUIDE WIRE WAS ADVANCED TO THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY VIA A TRANS-RADIAL APPROACH. THE GUIDE WIRE WAS EXCHANGED WITH AN ASAHI FIELDER FC WITH A MICROCATHETER TO INCREASE SUPPORT AND TO SMOOTHLY CROSS THE LESION. A 2.0 MM X 12 MM MINI TREK BALLOON CATHETER WAS INFLATED TO 18 ATMOSPHERE (ATM) FOLLOWED BY A 2.5 MM X 20 MM NON-ABBOTT BALLOON CATHETER BEING INFLATED TO 16 ATM AT THE PROXIMAL LAD. A 1.5 MM X 12 MM MINI TREK WAS ADVANCED TO THE ANGULAR CALCIFIED MID LAD BUT IT COULD NOT REACH THE TIGHT STENOTIC LESION. THE DEVICE WAS REMOVED. AT THE PROXIMAL LAD A 2.5 MM X 15 MM MINI VISION WAS ATTEMPTED TO BE ADVANCED BUT BECAME STUCK IN THE TIGHT STENOSIS; WHILE PULLING BACK THE STENT TO THE GUIDING CATHETER A LONG TYPE B DISSECTION FROM THE MID LEFT MAIN TO THE PROXIMAL LAD WAS NOTED. ONCE THE STENT WAS SUCCESSFULLY REMOVED FROM THE ANATOMY, THE STENT SHAPE WAS NOTED TO BE CURVED. TWO DIFFERENT NON-ABBOTT STENTS, A 2.75 MM X 14 MM AND A 2.75 MM X 18 MM RESPECTIVELY, WERE ADVANCED BUT COULD NOT PASS THE LESION. DURING REMOVAL OF BOTH STENT DELIVERY SYSTEMS, EACH STENT IMPLANT BECAME DISLODGED AND WAS RETRIEVED IN THE GUIDE CATHETER. ONCE THE STENT WAS REMOVED FROM THE ANATOMY AND GUIDE CATHETER THE STENT SHAPE WAS NOTED TO BE DEFORMED. THE PROCEDURE WAS ABANDONED. ADDITIONAL INFORMATION RECEIVED NOTED THE PATIENT WAS DISCHARGED APPROXIMATELY 1 WEEK POST PROCEDURE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT SUBMITTED, RETURN DEVICE ANALYSIS OF THE MINI VISION SDS REVEALED THE STENT WAS DISLODGED AND WAS NOT RETURNED. SUBSEQUENT INFORMATION RECEIVED FROM THE ACCOUNT, NOTED THE STENT WAS DISLODGED FROM THE BALLOON DURING THE PROCEDURE WHEN ATTEMPTING TO ADVANCE IT THROUGH THE PROXIMAL CIRCUMFLEX ARTERY. DURING REMOVAL THE STENT DISLODGED IN THE GUIDE CATHETER AND WAS REMOVED WITHOUT ISSUE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 1070741

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| R