BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1202492 · Received October 8, 2008

    Report

    Report Number
    2024168-2008-00921
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    August 29, 2008
    Report Date
    September 1, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO DETERMINE A CONCLUSIVE ROOT CAUSE FOR THE DISLODGED STENT. EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITHOUT ANY BLOOD OR CONTRAST VISIBLE. THE PROXIMAL END OF THE STENT IMPLANT WAS STATIONARY ON THE DISTAL END OF THE BALLOON. THE DISTAL END OF THE STENT IMPLANT EXTENDED PAST THE DISTAL END OF THE SOFT TIP. THE STENT IMPLANT WAS STRETCHED AND SLIGHTLY CRUSHED BETWEEN THE FOURTH AND FOURTEENTH ROW OF DISTAL STRUTS. THERE WAS NO OTHER DAMAGE NOTED TO THE STENT IMPLANT. THE BALLOON WAS TIGHTLY FOLDED. THERE WERE CRIMP MARKS ON THE BALLOON AND BETWEEN THE MARKERS. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. THE PROTECTIVE SHEATH WAS NOT RETURNED. A SNAP GAUGE WAS USED TO MEASURE THE OUTER DIAMETERS OF THE STENT IMPLANT. THE PROXIMAL AND DISTAL MEASUREMENTS MET MANUFACTURING CRITERIA. THE MIDDLE MEASUREMENTS WERE OVERSIZED AND DID NOT MEET MANUFACTURING CRITERIA. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION AND THE ANALYSIS OF THE RETURNED VISION SDS. THE ANALYSIS OF THE RETURNED SDS CONFIRMED THAT THE STENT WAS STRETCHED AND SLIGHTLY CRUSHED BETWEEN THE FOURTH AND FOURTEENTH ROW OF DISTAL STRUTS. HOWEVER, THE STENT WAS OBSERVED TO BE PUSHED DISTALLY TO WHERE THE DISTAL END OF THE STENT EXTENDED PAST THE SOFT TIP, ALTHOUGH THE PROXIMAL END OF THE STENT WAS STILL LOCATED ON THE DISTAL END OF THE BALLOON. FACTORS THAT CAN CONTRIBUTE TO THIS TYPE OF STENT DAMAGE INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, REMOVAL OF THE PROTECTIVE SHEATH, MISHANDLING, OR INTERACTIONS WITH OTHER DEVICES. IN ADDITION, STENT DISLODGEMENT OUTSIDE THE BODY CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING BUT NOT LIMITED TO, INADEQUATE CRIMPING DURING MANUFACTURING, INCORRECT SHEATH SIZING, POSITIVE PRESSURE DURING PREP, NEGATIVE PRESSURE DURING SHEATH REMOVAL OR FORCED SHEATH REMOVAL. IN THIS CASE, THE PROTECTIVE SHEATH WAS NOT RETURNED, WHICH MAY HAVE AIDED THE INVESTIGATION. FURTHERMORE, THE ANALYSIS REVEALED THAT THERE WERE CRIMP MARKS EVIDENT ON THE BALLOON WHERE THE STENT HAD BEEN BETWEEN THE MARKERS SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. DIMENSIONAL ANALYSIS ALSO INDICATED THAT THE OUTER DIAMETERS OF THE PROXIMAL AND DISTAL END OF THE STENT BOTH MET MANUFACTURING CRITERIA, BUT THE MIDDLE DIMENSION WAS ABOVE OF THE ACCEPTED MANUFACTURING SPECIFICATION. THIS MAY BE DUE TO THE STENT DAMAGE OR AS A RESULT OF THE STENT MOVEMENT, AS IT IS EXPECTED THAT THE STENT WOULD EXPAND DURING TRAVEL OVER THE BALLOON. HOWEVER, BASED ON THE INFORMATION RECEIVED WITH THIS COMPLAINT AND THE RETURNED ANALYSIS, A CONCLUSIVE ROOT CAUSE FOR THE REPORTED DISCREPANCY COULD NOT BE DETERMINED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS LOT AND ALL ON-LINE INSPECTIONS AND TESTING MET MANUFACTURING CRITERIA. A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED; THEREFORE, NO CORRECTIVE ACTION WILL BE IMPLEMENTED IN THIS CASE. PRODUCT PERFORMANCE ENGINEERING WILL TREND AND MONITOR THE EXPERIENCE CIRCUMSTANCES. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT DAMAGE. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: STENT DISLODGMENT HAS CAUSED OR CONTRIBUTED TO PATIENT INJURY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT DURING PREPARATION, WHEN THE PROTECTIVE SHEATH WAS REMOVED FROM THE STENT DELIVERY SYSTEM (SDS), THE DISTAL SIDE OF THE STENT HAD BEEN STRETCHED TO THE DISTAL SIDE. IT WAS NOTED THAT THE PROTECTIVE SHEATH WAS NOT REMOVED WITH FORCE. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. THIS IS BEING FILED BASED ON THE ANALYSIS OF THE RETURNED DEVICE WHICH REVEALED THAT THE STENT WAS PARTIALLY DISLODGED FROM THE BALLOON.

    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 8032731

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK