BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 1203136 · Received October 8, 2008

    Report

    Report Number
    2024168-2008-00922
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 10, 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
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    QUALITY ENGINEERING WAS UNABLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED STENT DISLODGEMENT. EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITH BLOOD VISIBLE ON THE BALLOON AND IN THE GUIDE WIRE LUMEN. THE STENT IMPLANT WAS DISLODGED. THERE WERE TWO STRUTS IN THE FIRST ROW AT THE DISTAL END OF THE STENT IMPLANT THAT WERE FLARED. THERE WAS NO OTHER DAMAGE NOTED TO THE STENT IMPLANT. THE BALLOON WAS TIGHTLY FOLDED. THE DISTAL END OF THE BALLOON WAS BUNCHED. THERE WERE CRIMP MARKS ON THE BALLOON AND BETWEEN THE MARKERS. THE PROTECTIVE SHEATH WAS NOT RETURNED. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. A SNAP GAUGE WAS USED TO MEASURE THE OUTER DIAMETER OF THE STENT IMPLANT. THIS IS A DEVIATION FROM NORMAL TESTING DUE TO THE EQUIPMENT BEING SERVICED. THE STENT IMPLANT OUTER DIAMETER MEASUREMENTS DID NOT MEET MANUFACTURING CRITERIA. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION AND THE ANALYSIS OF THE RETURNED RX VISION STENT DELIVERY SYSTEM (SDS). 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 MANUFACTURE. THE ANALYSIS OF THE SDS CONFIRMED THAT THE STENT HAD DISLODGED. HOWEVER, THE ANALYSIS REVEALED THAT THERE WERE CRIMP MARKS EVIDENT ON THE TIGHTLY FOLDED BALLOON WHERE THE STENT HAD BEEN BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. IN ADDITION, THERE WAS BLOOD FOUND ON THE BALLOON AND IN THE GUIDE WIRE LUMEN. THIS IS CONSISTENT WITH THE DEVICE BEING AT LEAST ADVANCED OVER A GUIDE WIRE AND SUGGESTS THAT THE SDS MAY HAVE BEEN INSERTED INTO THE BODY, THOUGH THIS COULD NOT BE CONFIRMED. FURTHERMORE, THERE WERE TWO STRUTS IN THE FIRST ROW AT THE DISTAL END OF THE STENT IMPLANT THAT WERE FLARED. THE DISTAL END OF THE BALLOON WAS ALSO NOTED TO BE BUNCHED. THE MECHANICAL DAMAGE TO THE STENT AND BALLOON BUNCHING LIKELY OCCURRED DURING REMOVAL OF THE PROTECTIVE SHEATH AND/OR DURING PACKAGING FOR SHIPMENT BACK TO ABBOTT VASCULAR. IF SIGNIFICANT PRESSURE IS INADVERTENTLY APPLIED DURING REMOVAL OF THE PROTECTIVE SHEATH, THE STENT CAN SUSTAIN MECHANICAL DAMAGE AND BECOME DISRUPTED ON THE BALLOON, WHICH MAY ALSO FACILITATE DISLODGEMENT. AS A RESULT, THE OUTER DIAMETERS OF THE STENT IMPLANT CAN BECOME OVERSIZED AND ABOVE THE ACCEPTED MANUFACTURING SPECIFICATIONS AS NOTED DURING DIMENSIONAL ANALYSIS. THIS MAY HAVE OCCURRED AT THE TIME OF DISLODGEMENT AS IT IS EXPECTED THAT THE STENT WOULD EXPAND DURING TRAVEL OVER THE BALLOON. UNFORTUNATELY, THE PROTECTIVE SHEATH WAS NOT RETURNED IN THIS CASE, WHICH MAY HAVE AIDED THE INVESTIGATION. THEREFORE, BASED ON THE INFORMATION RECEIVED WITH THIS COMPLAINT AND THE RETURNED DEVICE ANALYSIS, A CONCLUSIVE ROOT CAUSE FOR REPORTED DISCREPANCY COULD NOT BE DETERMINED. TO ENSURE THIS TYPE OF DAMAGE IS NOT A RESULT OF A MANUFACTURING RELATED ISSUE, ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT DAMAGE, STENT PLACEMENT/SECURITY AND DIMENSIONALLY INSPECTED TO VERIFY THE CRIMPED STENT OUTER DIAMETERS. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD (LHR) DID NOT REVEAL ANY NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND ALL ON-LINE INSPECTIONS AND TESTING MET MANUFACTURING CRITERIA. IN ADDITION, A QUERY OF THE COMPLAINT-HANDLING DATABASE DID NOT REVEAL ANY SIMILAR INCIDENTS REPORTED WITH THIS PART AND LOT NUMBER COMBINATION, WHICH SUGGESTS THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY ISSUES. PRODUCT PERFORMANCE ENGINEERING WILL TREND AND MONITOR THE EXPERIENCE CIRCUMSTANCES. THE PROFILE DIMENSIONS ON ALL DEVICES ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE AT ABBOTT VASCULAR. ADDITIONALLY, ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: STENT DISLODGEMENT HAS OCCURRED IN PATIENT ANATOMY AND CAUSED OR CONTRIBUTED TO PATIENT INJURY PREVIOUSLY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE STENT DISLODGED DURING PREP, OUTSIDE OF THE PATIENT'S BODY. THE DEVICE WAS NOT USED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM 74MAF MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 8060941

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK