BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1052386 · Received May 23, 2008

    Report

    Report Number
    2024168-2008-00422
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    March 3, 2008
    Report Date
    March 3, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: PRODUCT PERFORMANCE ENGINEERING COULD NOT DETERMINE A CONCLUSIVE ROOT CAUSE FOR THE REPORTED STENT DISLODGEMENT. EVAL SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITHOUT BLOOD OR CONTRAST VISIBLE. THERE WAS FLUID IN THE INFLATION LUMEN. THE STENT IMPLANT WAS STATIONARY ON THE BALLOON BUT WAS NOT LOCATED BETWEEN THE MARKERS. THE STENT IMPLANT HAD MOVED DISTALLY FOR A LENGTH OF 2.5 MM. THE STENT IMPLANT ORIENTATION WAS REVERSED AS IF IT HAD DISLODGED AND WAS PLACED BACK ON THE BALLOON IN THE WRONG DIRECTION. THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT. THE BALLOON WAS TIGHTLY FOLDED. THERE WERE CRIMP MARKS ON THE BALLOON BETWEEN THE MARKERS. THERE WAS BALLOON SHREDDING THROUGHOUT THE ENTIRE LENGTH OF THE BALLOON AND IN BETWEEN THE STENT STRUTS. THERE MULTIPLE BENDS THROUGHOUT THE ENTIRE LENGTH OF THE HYPOTUBE. A LASER MICROMETER WAS USED TO MEASURE THE OUTER DIAMETERS OF THE STENT IMPLANT. THE OUTER DIAMETER MEASUREMENTS DID NOT MEET MFG CRITERIA. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO AND THE RETURNED DEVICE ANALYSIS. THE ANALYSIS NOTED THAT THE STENT IMPLANT STATIONARY ON THE TIGHTLY FOLDED BALLOON BUT WAS MOVED DISTALLY FOR A LENGTH OF 2.5 MM. HOWEVER, FURTHER ANALYSIS OF THE DEVICE REVEALED THAT THE STENT WAS BACKWARDS ON THE BALLOON. THERE WERE CRIMP MARKS ON THE BALLOON BETWEEN THE MARKERS. THE CRIMP MARKS ON THE BALLOON SHOW THAT THE STENT IMPLANT WAS INITIALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MFR. THIS SUGGESTS THAT THE STENT IMPLANT HAD DISLODGED AND MAY HAVE BEEN RECRIMPED BACK ONTO THE BALLOON. THERE WAS FLUID VISIBLE IN THE INFLATION LUMEN, ALSO SUGGESTING THAT, AT SOME POINT, POSITIVE PRESSURE MAY HAVE BEEN APPLIED TO THE SYSTEM, FORCING THE BALLOON TO SLIGHTLY EXPAND; THEREFORE, PARTIALLY DEPLOYING THE STENT. THIS WOULD ALSO CAUSE THE STENT TOO BECOME LOOSE, FACILITATING STENT DISLODGEMENT DURING REMOVAL OF THE PROTECTIVE SHEATH. AS A RESULT, THE OUTER DIAMETERS OF THE STENT WOULD BE OVERSIZED AND OUT OF SPECIFICATION. FACTORS THAT CAN AFFECT STENT DISLODGEMENT OUTSIDE THE BODY INCLUDE, BUT ARE NOT LIMITED TO, POSITIVE PRESSURE DURING PREP, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, OR IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MFR. IN THIS CASE, THE PROTECTIVE SHEATH WAS NOT RETURNED, WHICH WOULD HAVE AIDED THE INVESTIGATION. IN ADDITION, THERE WAS BALLOON SHREDDING OBSERVED THROUGHOUT THE ENTIRE LENGTH OF THE BALLOON AND IN BETWEEN THE STENT STRUTS. THIS DAMAGE WAS NOT OBSERVED DURING INSPECTION PRIOR TO USE, THUS, LIKELY OCCURRED WHEN FORCING THE STENT BACK ONTO THE BALLOON AFTER DISLODGEMENT. THIS WOULD CAUSE THE BALLOON MATERIAL TO WEAKEN AND SHRED. ULTIMATELY, THE SHREDDING APPEARS TO BE RELATED TO MISHANDLING, HOWEVER, A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED. ADDITIONALLY, THERE WERE MULTIPLE BENDS NOTED THROUGHOUT THE ENTIRE LENGTH OF THE HYPOTUBE. AGAIN, THIS DAMAGE WAS NOT OBSERVED DURING PRODUCT INSPECTION PRIOR TO USE AND THUS, MAY HAVE OCCURRED DURING PACKAGING AND SHIPMENT BACK TO ABBOTT VASCULAR FOR ANALYSIS. THIS DAMAGE DOES NOT APPEAR TO BE RELATED TO OR TO HAVE CONTRIBUTED TO THE REPORTED STENT DISLODGEMENT. BASED ON THE INCIDENT INFO AND THE RETURNED DEVICE ANALYSIS, A CONCLUSIVE ROOT CAUSE FOR THE REPORTED STENT DISLODGEMENT COULD NOT BE DETERMINED. PRODUCT PERFORMANCE ENGINEERING WILL TREND AND MONITOR THE EXPERIENCE CIRCUMSTANCES. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT AND A SAMPLING OF UNITS ARE DESTRUCTIVELY TESTED TO VERITY STENT MOVEMENT (DISLODGEMENT FORCE). 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 PT INJURY PREVIOUSLY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE STENT DISLODGED FROM THE BALLOON WHEN THE STYLET WAS REMOVED FROM THE STENT DELIVERY SYSTEM (SDS). THERE WAS NO PT INVOLVEMENT. NO ADD'L EVENT OR PT 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 8010231

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK