BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1840006 · Received September 16, 2010

    Report

    Report Number
    2024168-2010-01923
    Event Type
    Malfunction
    Date Received
    September 16, 2010
    Date of Event
    July 28, 2010
    Report Date
    August 10, 2010
    Manufacturer
    ABBOTT VASCULAR CLONMEL
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE WHISPER MS GUIDE WIRE (PART 1005357H, LOT 9121991) IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. EVAL SUMMARY: THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITH BLOOD IN THE INFLATION LUMEN, IN THE GUIDE WIRE LUMEN, AND ON THE BALLOON. THERE WAS NO CONTRAST VISIBLE. THE STENT IMPLANT WAS STATIONARY ON THE BALLOON BETWEEN THE MARKERS. THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT. THE BALLOON WAS TIGHTLY FOLDED. THERE WAS BALLOON SHREDDING AT THE PROXIMAL BALLOON SEAL FOR A LENGTH OF 4 MM AND AT THE DISTAL BALLOON SEAL FOR A LENGTH OF 4 MM. THE SOFT TIP WAS BUNCHED .5 MM PROXIMAL TO THE DISTAL END FOR A LENGTH OF 1.5 MM. THERE WAS A HOLE IN THE INNER AND OUTER MEMBER 6.5 AND 8.3 CM PROXIMAL TO THE PROXIMAL BALLOON SEAL. THERE WERE SEVERAL LONGITUDINAL SCRATCHES ON THE ENTIRE LENGTH OF THE OUTER MEMBER. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. ANALYSIS NOTED BALLOON SHREDDING AT THE PROXIMAL BALLOON SEAL FOR A LENGTH OF 4 MM AND THE DISTAL BALLOON SEAL FOR A LENGTH OF 4 MM, WHICH WAS NOT INITIALLY REPORTED WITH THE INCIDENT INFO. THE BALLOON PEELING APPEARS TO BE THE RESULT OF THE PROCEDURE CIRCUMSTANCES, AS THERE WAS NO REPORT OF ANY DAMAGE TO THE BALLOON DURING VISUAL INSPECTION OR PREPARATION OF THE PRODUCT PRIOR TO THE PROCEDURE. ALTHOUGH BALLOON PEELING OR SHREDDING IS OCCASIONALLY SEEN ON MFG PRODUCTION LINES, IT IS MORE LIKELY THAT THE BALLOON PEELING OCCURRED DURING THE FAILED ATTEMPT TO CROSS THE LESION. TO HELP ENSURE THAT THE BALLOON SHREDDING IS NOT A RESULT OF A MFG DEFICIENCY, ALL SDS ARE VISUALLY INSPECTED FOR BALLOON SHREDDING. IT IS POSSIBLE THAT THE BALLOON MAY HAVE SCRAPED AGAINST THE CALCIFIED LESION, WHICH MAY HAVE CONTRIBUTED TO THE SHREDDING OF THE BALLOON MATERIAL. ANALYSIS ALSO NOTED A HOLE IN THE INNER AND OUTER MEMBER 6.5 AND 8.3 CM PROXIMAL TO THE PROXIMAL BALLOON SEAL. THERE WERE SEVERAL LONGITUDINAL SCRATCHES ON THE ENTIRE LENGTH OF THE OUTER MEMBER. IN THIS CASE, IT IS LIKELY THAT THE SHAFT WAS DAMAGED (SCRATCHED) DURING INTERACTION WITH OTHER DEVICES AND/OR THE CALCIFIED LESION, RESULTING IN THE TEARS IN THE SHAFT. IN THIS CASE, THE REPORTED TIP DAMAGE AND NOTED BALLOON SHREDDING AND SHAFT DAMAGE APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. A REVIEW OF THE PRODUCT MFG RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MFG CRITERIA. ALL STENT DELIVERY SYSTEMS ARE SUBJECTED TO A 100% VISUAL INSPECTION. IN ADDITION, A QC AUDIT INSPECTION IS USED TO VERIFY THE PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA), AND A NON-ABBOTT 1/6 GUIDE CATHETER WAS USED AND THEN A NON-ABBOTT 4/6 GUIDE CATHETER WAS USED TO ENGAGE THE OSTIUM OF THE RCA BUT POOR SUPPORT WAS NOTED. THE GUIDE CATHETER WAS SHIFTED TO A NON-ABBOTT 1/6 AND ENGAGED THE RCA OSTIUM SMOOTHLY. A WHISPER MS GUIDE WIRE WAS ADVANCED TO THE RCA AND A VISION 3.5 X 15 ADVANCED. DURING DILATION OF THE VISION, THE WHISPER GUIDE WIRE ALL OF A SUDDEN SNAPPED IN TWO. BECAUSE THE GUIDE WIRE SNAPPED, THE VISION'S SOFT TIP WAS FLARED. WHEN THE GUIDE WIRE WAS PULLED BACK, THE FRONT PIECE WAS IN THE RCA AND WAS RETRIEVED VIA SNARE. THE VISION WAS NOT DEPLOYED AND WAS WITHDRAWN. THE LESION WAS TREATED WITH 2 NON-ABBOTT STENTS. THE PT IS STABLE. THE ANALYSIS OF THE RETURNED DEVICE IDENTIFIED THAT THE BALLOON WAS SHREDDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM MAF ABBOTT VASCULAR CLONMEL NA 9092542

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: WHISPER MS GUIDE WIRE| (PART 1005357H, LOT 9121991)| DIL CATH: VOYAGER| 2 MEDTRONIC'S RESOLUTE| STENT: VISION 3.5 15| GUIDE CATH: AL 6/1.0