BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1033801 · Received April 24, 2008

    Report

    Report Number
    2024168-2008-00339
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    March 27, 2008
    Report Date
    March 27, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    PO20047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION/PERMANENT DAMAGE. REPORTING RATIONALE: DISLODGED STENT WAS COMPRESSED AGAINST THE VESSEL WALL IN AN UNINTENDED SITE. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE PROCEDURE WAS TO DIRECT STENT A LESION IN THE DISTAL RCA, WHICH WAS DISTAL TO THREE PREVIOUSLY IMPLANTED STENTS. AS A 2.75 X 12 MM VISION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, IT WAS PUSHED HARD TO TRY TO MOVE IT FORWARD; HOWEVER, IT COULD NOT BE ADVANCED THROUGH THE VESSEL. AFTER CHANGING THE GUIDE WIRE, THE GUIDING CATHETER, AND PERFORMING SOME PRE-DILATATION WITH A BALLOON CATHETER, THE SDS STILL WOULD NOT CROSS. USING A BUDDY WIRE SYSTEM A THIRD ATTEMPT WAS MADE TO CROSS WITH THE SDS. AFTER THE THIRD CROSS ATTEMPT FAILED; DURING REMOVAL OF THE SDS, THE STENT DISLODGED AND REMAINED IN THE PROXIMAL RCA. THERE WERE SEVERAL ATTEMPTS MADE TO SNARE THE DISLODGED STENT, BUT THE SNARE ATTEMPTS WERE UNSUCCESSFUL. A BALLOON CATHETER WAS USED TO COMPRESS THE STENT AGAINST THE VESSEL WALL AND THEN ANOTHER STENT WAS USED TO COVER THE COMPRESSED STENT. THE TARGET LESION WAS TREATED WITH PLAIN OLD BALLOON ANGIOPLASTY (POBA) ONLY. REPORTEDLY, THE PATIENT IS DOING WELL. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM 74MAF MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 7030851

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention| S STENT: VISION| (X2) POWERSAILS| DIL CATH: (X2) VOYAGERS| GUIDE WIRE: CHOICE PT EXTRA SUPPORT| PILOT 50| GUIDING CATHETER: AL GUIDING CATHETER