BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1122286 · Received August 13, 2008

    Report

    Report Number
    2024168-2008-00660
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 13, 2008
    Report Date
    July 14, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    PO20047
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - PRODUCT PERFORMANCE ENGINEERING COULD NOT DETERMINE A CONCLUSIVE ROOT CAUSE FOR THE STENT DISLODGEMENT. EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITH BLOOD VISIBLE IN THE GUIDE WIRE LUMEN AT THE DISTAL END. THERE WAS CONTRAST VISIBLE IN THE BALLOON AND INFLATION LUMEN. THE STENT WAS DISLODGED, AND LOCATED ON THE STYLET, AND PARTIALLY INSIDE THE PROTECTIVE SHEATH. THERE WAS CONTRAST VISIBLE ON THE STENT. THERE WERE FLARED STRUTS ON THE FIRST AND SECOND ROW AT THE PROXIMAL END OF THE STENT. THE BALLOON WAS LOOSELY FOLDED. THERE WERE NO VISIBLE CRIMP MARKS ON THE BALLOON. A SNAP GAUGE WAS USED TO MEASURE THE OUTER DIAMETERS OF THE STENT IMPLANT. THE OUTER DIAMETER MEASUREMENTS FOR THE DISTAL AND MIDDLE MET MANUFACTURING CRITERIA. THE PROXIMAL OUTER DIAMETER MEASUREMENTS DID NOT MEET MANUFACTURING CRITERIA. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO AND THE ANALYSIS OF THE RETURNED RX VISION SDS. REPORTEDLY, THERE WAS NO PATIENT INVOLVEMENT IN THIS CASE. FACTORS THAT CAN AFFECT STENT DISLODGEMENT OUTSIDE THE BODY INCLUDE, BUT ARE NOT LIMITED TO, POSITIVE PRESSURE DURING PREPARATION, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, OR IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE. THE ANALYSIS CONFIRMED THAT THE STENT HAD DISLODGED AND WAS LOCATED ON THE STYLET AND PARTIALLY INSIDE THE PROTECTIVE SHEATH. THERE WAS BLOOD PRESENT IN THE GUIDE WIRE LUMEN AND CONTRAST VISIBLE IN THE INFLATION LUMEN, WHICH IS CONSISTENT WITH THE DEVICE BEING PREPPED FOR USE, AND AT LEAST BEING ADVANCED OVER A GUIDE WIRE IN THIS CASE. IN ADDITION, THERE WAS ALSO CONTRAST PRESENT IN THE BALLOON, WHICH WAS LOOSELY FOLDED, SUGGESTING THAT, AT SOME POINT, POSITIVE PRESSURE MAY HAVE BEEN APPLIED TO THE SYSTEM. IF POSITIVE PRESSURE IS INADVERTENTLY APPLIED DURING PREPARATION, THE STENT IMPLANT CAN BECOME DISRUPTED ON THE BALLOON, WHICH MAY ALSO FACILITATE STENT DISLODGEMENT. THERE WERE NO VISIBLE CRIMP MARKS PRESENT ON THE BALLOON; HOWEVER, THIS MAY BE DUE TO THE LOOSE BALLOON FOLDS OR POSITIVE PRESSURE APPLIED DURING DEVICE PREPARATION. FURTHERMORE, THERE WERE FLARED STRUTS OBSERVED IN THE FIRST AND SECOND ROW AT THE PROXIMAL END OF THE STENT. THIS DAMAGE MAY HAVE OCCURRED DURING OR AFTER THE PROCEDURE, AS IT WAS NOT REPORTED IN THE INCIDENT REPORT. THE OUTER DIAMETERS OF THE MIDDLE AND DISTAL END OF THE STENT BOTH MET MANUFACTURING CRITERIA, BUT THE PROXIMAL DIMENSIONS WERE ABOVE THE ACCEPTED MANUFACTURING SPECIFICATION. THIS MAY BE DUE TO THE STENT DAMAGE OR AS A RESULT OF THE STENT DISLODGEMENT, AS IT IS EXPECTED THAT THE STENT WOULD EXPAND DURING TRAVEL OVER THE BALLOON. THE INNER DIAMETER OF THE PROTECTIVE SHEATH WAS ALSO WITHIN MANUFACTURING SPECIFICATION. BASED ON THE INFO RECEIVED WITH THIS INCIDENT AND THE DEVICE ANALYSIS, NO CONCLUSIVE ROOT CAUSE COULD BE DETERMINED FOR THE REPORTED DIFFICULTIES IN THIS CASE. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH EITHER LOT. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: STENT DISLODGEMENT HAS CAUSED OR CONTRIBUTED TO PATIENT INJURY PREVIOUSLY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT DURING PREPARATION, THE VISION STENT CAME OFF THE BALLOON WHEN THE STYLET WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER COMPANY'S STENT. NO ADDITIONAL EVENT OR PATIENT INFO 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 7082931

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK