BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK MINI VISION RXCORONARY STENT SYSTEM

    MDR report key: 1839639 · Received September 16, 2010

    Report

    Report Number
    2024168-2010-01931
    Event Type
    Injury
    Date Received
    September 16, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 23, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RX MINI VISION 2.25 X 12 MM (PART #1007822-12/LOT#9110941) MENTIONED IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER. EVALUATION SUMMARY: THE MINI VISION STENT DELIVERY SYSTEM (SDS) WAS NOT RETURNED WHICH MAY HAVE AIDED IN THE EVALUATION. FACTORS WHICH MAY CONTRIBUTE TO DIFFICULTY WHEN POSITIONING A SDS INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, ANATOMICAL CONDITIONS, STENT IMPLANT OUTER DIAMETER, DAMAGE TO THE STENT IMPLANT, KINKS, BENDS, GUIDING CATHETER SIZE SELECTION, OR OBSTRUCTIONS IN THE GUIDING CATHETER LUMEN. TO HELP ENSURE THIS DIFFICULTY IS NOT RELATED TO A MANUFACTURING DEFICIENCY, THE STENT IS CHECKED FOR PROPER STRUT DIMENSIONS, AND THE STENT IS INSPECTED AT MULTIPLE STEPS IN THE PROCESS FOR STENT DAMAGE DURING THE MANUFACTURING PROCESS. IT WAS REPORTED THE MINI VISION SDS WAS ATTEMPTED TO ADVANCE THROUGH A PREVIOUSLY DEPLOYED STENT, WHICH LIKELY CONTRIBUTED TO THE DIFFICULTIES. IT IS LIKELY THE 2.25 X 15 MM MINI VISION STENT INTERACTED WITH THE PREVIOUSLY DEPLOYED STENT, CAUSING DAMAGE TO THE STENT AND CONTRIBUTING TO THE REPORTED DIFFICULTY POSITIONING THE STENT. THE STENT WAS EVENTUALLY DEPLOYED INSIDE OF THE 2.5 X 23 MM MINI VISION STENT. IT SHOULD BE NOTED IN THE MINI VISION INSTRUCTIONS FOR USE (IFU) IT STATES: WHEN TREATING MULTIPLE LESIONS, STENT THE DISTAL LESION PRIOR TO STENTING THE PROXIMAL LESION. STENTING IN THIS ORDER OBVIATES THE NEED TO CROSS THE PROXIMAL STENT IN PLACEMENT OF THE DISTAL STENT, AND REDUCES THE CHANCE OF DISLODGING THE PROXIMAL STENT. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED, AND THERE HAS BEEN NO SIMILAR INCIDENTS REPORTED FOR DIFFICULTY TO POSITION, USE ERRORS, OR THE PT EFFECTS OF FOREIGN BODY IN PT FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE REPORTED DIFFICULTY POSITIONING THE SDS APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MID LEFT ANTERIOR DESCENDING (LAD) STENTING PROCEDURE, IN A TOTALLY OCCLUDED, HEAVILY CALCIFIED LESION, THE MINI VISION STENTS WERE BEING PLACED FROM PROXIMAL TO DISTAL THROUGH THE NARROW LESION. THE PT WAS RESTLESS AND WAS MOVING AROUND A LOT. A 2.5 X 23 MM MINI VISION WAS PLACED MOST PROXIMALLY IN THE LESION. DURING POST-STENT DILATATION WITH A VOYAGER DILATATION BALLOON, A DISSECTION OCCURRED AT THE DISTAL EDGE OF THE STENT. A SECOND PLANNED MINI VISION (2.25 X 15 MM) WAS INSERTED, DISTALLY, TO THE LESION; HOWEVER, SINCE IT WAS NOT ADEQUATELY OVERLAPPING THE FIRST STENT, THE STENT DELIVERY SYSTEM (SDS) WAS PULLED BACK. THE SDS WAS PULLED BACK TOO MUCH AND WAS COMPLETELY INSIDE THE PREVIOUSLY PLACED STENT. RESISTANCE WAS MET WHEN ADVANCING THE STENT, SO IT WAS DECIDED TO PLACE THE STENT INSIDE THE PREVIOUSLY PLACED STENT. A THIRD PLANNED MINI VISION (2.25 X 12 MM) WAS ADVANCED; HOWEVER, WHILE ADVANCING THROUGH THE TWO PREVIOUSLY PLACED STENTS, RESISTANCE WAS MET. WHILE ATTEMPTING TO REMOVE THE STENT, IT DISLODGED FROM THE BALLOON ONTO THE PILOT 50 WIRE. THE BALLOON WAS ADVANCED AND WAS ABLE TO DEPLOY THE STENT INSIDE THE TWO PREVIOUSLY PLACED STENTS. THE PT REMAINED STABLE DURING THE PROCEDURE. THE PROCEDURE WAS STOPPED. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK MINI VISION RXCORONARY STENT SYSTEM MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 9111841

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other (PART #1007822-12/LOT#9110941)| 2.5 X 23 MM MINI VISION| STENT: RX MINI VISION 2.25 X 12MM| PROWATER| OTHER: HEPARIN| DILATATION CATHETER: VOYAGER DILATATION BALLOON| GUIDE WIRE: PILOT 50