BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 822968 · Received January 3, 2007

    Report

    Report Number
    2024168-2007-00003
    Event Type
    Malfunction
    Date Received
    January 3, 2007
    Date of Event
    December 4, 2006
    Report Date
    December 4, 2006
    Manufacturer
    GUIDANT VASCULAR INTERVENTION
    Product Code
    MAF
    PMA / PMN Number
    po20047
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PROCESSING OF THIS COMPLAINT, PRODUCT PERFORMANCE GROUP ATTEMPTED TO OBTAIN COMPLETE EVENT INFORMATION, INCLUDING PATIENT INFORMATION AND PATIENT STATUS FROM THE HOSPITAL, FIELD CONTACT OR DISTRIBUTOR. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THE STENT DISLODGEMENT. THE SECOND RX VISION INDICATED IN THE EVENT DESCRIPTION AND IN THE CONCOMITANT MEDICAL PRODCUTS IS BEING REPORTED UNDER MFR# 2024168-2007-00002. EVALUATION SUMMARY: QUALITY ASSURANCE OF THE RETURNED DEVICE REVEALED THAT THE CATHETER WAS RETURNED WITHOUT ANY BLOOD. THERE WAS FLUID VISIBLE IN THE INFLATION LUMEN. THE PROTECTIVE SHEATH AND STYLET WERE RETURNED, THERE WAS NO STENT IN THE SHEATH. THERE WERE CRIMP MARKS ON THE BALLOON WHERE THE STENT HAD BEEN BETWEEN THE MARKERS. THE BALLOON WAS TIGHTLY FOLDED. THERE WAS NO OTHER DAMAGE NOTED. THE TIP SEAL LENGTH WAS MEASURED AND MET MANUFACTURING CRITERIA. THE INNER DIAMETER OF THE PROTECTIVE SHEATH WAS MEASURED USING A PIN GAUGE AND MET SPECIFICATION. THE STENT OUTER DIAMETER COULD NOT BE MEASURED DUE TO NO STENT. NO OTHER DAMAGE WAS NOTED. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION AND ANALYSIS OF THE RETURNED DEVICE. IT WAS REPORTED THAT THE STENT DISLODGED ON THE STYLET WHEN THE PROTECTIVE SHEATH WAS RETURNED. QUALITY ASSURANCE TECHNICIAN ANALYSIS CONFIRMED THAT THE STENT HAD DISLODGED AS NO STENT WAS RETURNED WITH THE STYLET, PROTECTIVE SHEATH AND CATHETER. HOWEVER, CRIMP MARKS WERE VISIBLE ON THE BALLOON AND BETWEEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. ASLO, THE INNER DIAMETER OF THE PROTECTIVE SHEATH WAS IN SPECIFICATION. THE RETURNED CATHETER HAD FLUID IN THE INFLATION LUMEN, WHICH SUGGESTS THAT THE DEVICE MAY HAVE BEEN PREPARED FOR USE. IF AT SOME POINT, POSITIVE PRESSURE WAS APPLIED TO THE SYSTEM, THIS COULD CAUSE THE BALLOON TO SLIGHTLY EXPAND AND PARTIALLY DEPLOY THE STENT, AND FACILITATE THE DISLODGEMENT OF THE STENT. HOWEVER, IT WAS REPORTED THAT THE DEVICE WAS JUST REMOVED FROM THE PACKAGING. REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT INDICATE THAT THERE WERE NO NONCONFORMITIES ASSOCIATED WITH THIS LOT AND ALL RELEASE TESTING FOR CRIMPED STENT DIAMETER, STENT PLACEMENT AND SECURITY MET SPECIFICATION. POTENTIAL CAUSES FOR THIS TYPE OF EVENT AS OBSERVED IN PAST INCIDENTS MAY INCLUDE IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, POSITIVE PRESSURE DURING PREP, NEGATIVE PRESSURE DURING SHEATH REMOVAL OR FORCED SHEATH REMOVAL. UNFORTUNATELY, NONE OF THE INFORMATION GATHERED SUGGESTS ANY OF THESE CAUSES IS THE MOST LIKELY CAUSE, THUS A DEFINITIVE ROOT CAUSE FOR THE STENT DISLODGEMENT IN THIS CASE CANNOT BE DETERMINED. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT AND SECURITY. 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 PATIENT INJURY PREVIOUSLY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE LAD. THREE ATTEMPTS WERE MADE WITH THE FIRST VISION (LOT# 6091231) TO CROSS, BUT IT WAS UNSUCCESSFUL EVEN AFTER THREE ADDITIONAL PRE-DILATATIONS. AS THE VISION WAS BEING RETRATCED INTO THE GUIDING CATHETER, THE STENT DISLODGED. ANOTHER COMPANY'S BALLOON WAS USED TO RETRIEVE THE DISLODGED STENT. A NEW VISION (LOT# 6092531) WAS REMOVED FROM THE PACKAGE, BUT WHEN THE PROTECTIVE SHEATH WAS REMOVED, THE STENT DISLODGED ON THE STYLET WIRE. THE PROCEDURE WAS COMPLETED USING TWO OF ANOTHER COMPANY'S STENTS. THERE WERE NO PATIENT EFFECTS REPORTED. 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 GUIDANT VASCULAR INTERVENTION NA 6092531

    Patients

    Seq Age Sex Outcome Treatment
    1 YR 3.0 X 08 MM RX VISION, DRIVER STENT X 2| STENT: 3.0 X 12 MM RX VISION| DIL CATH: VOYAGER, POWERSAIL X 2