BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1031217 · Received April 17, 2008

    Report

    Report Number
    2024168-2008-00303
    Event Type
    Injury
    Date Received
    April 17, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 18, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    PO20047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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 DISSECTION. EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE SDS WAS RETURNED WITHOUT BLOOD VISIBLE. THERE WAS CONTRAST VISIBLE IN THE INFLATION LUMEN AND BALLOON. THE STENT IMPLANT WAS RETURNED DISLODGED FROM THE SDS ON THE STYLET AND IN THE PROTECTIVE SHEATH. THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT. THE BALLOON WAS LOOSELY FOLDED. THERE WERE SLIGHT CRIMP MARKS VISIBLE ON THE BALLOON BETWEEN THE MARKERS. THERE WAS NO DAMAGE NOTED TO THE SDS. A LASER MICROMETER WAS USED TO MEASURE THE STENT IMPLANT OUTER DIAMETER, AND THEY DID NOT MEET MANUFACTURING CRITERIA. THE MEASUREMENTS WERE OVERSIZED. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO AND ANALYSIS OF THE RETURNED RX VISION SDS. IT SHOULD BE NOTED THAT THE INSPECTIONS PRIOR TO USE SECTION OF THE VISION INSTRUCTIONS FOR USE (IFU) STATES, "NOTE: PRIOR TO USING THIS DEVICE, CAREFULLY REMOVE THE SYSTEM FROM THE PACKAGE AND INSPECT FOR BENDS, KINKS, AND OTHER DAMAGE. AFTER REMOVING THE MANDREL, REMOVE THE PROTECTIVE SHEATH CAREFULLY WHILE HOLDING ITS DISTAL END. VERIFY THAT THE STENT DOES NOT EXTEND BEYOND THE RADIOPAQUE BALLOON MARKERS. DO NOT USE IF ANY DEFECTS ARE NOTED." IN THIS CASE, THE STENT HAD DISLODGED PRIOR TO USE. ANALYSIS OF THE SDS CONFIRMED THAT THE STENT WAS DISLODGED FROM THE BALLOON AND WAS RETURNED UNDAMAGED INSIDE THE PROTECTIVE SHEATH. THE INNER DIAMETER DIMENSION OF THE PROTECTIVE SHEATH WAS MEASURED AND MET MANUFACTURING CRITERIA. SLIGHT CRIMP MARKS WERE VISIBLE BETWEEN THE MARKERS ON THE LOOSELY FOLDED BALLOON. THE PRESENCE OF CONTRAST IN THE INFLATION LUMEN AND BALLOON SUGGESTS THAT, AT SOME POINT, POSITIVE PRESSURE MAY HAVE BEEN APPLIED TO THE SYSTEM CAUSING THE BALLOON TO SLIGHTLY EXPAND, PARTIALLY DEPLOYING THE STENT. THIS WOULD CAUSE THE STENT TO BECOME LOOSE, THE OUTER DIAMETER TO BE OUT OF SPECIFICATION, AND THE STENT TO DISLODGE DURING REMOVAL OF THE PROTECTIVE SHEATH. THE STENT DISLODGEMENT APPEARS TO BE RELATED TO THE CIRCUMSTANCES OF THE PROCEDURE/PREPARATION AND NOT A PRODUCT QUALITY ISSUE. DISSECTION, AS LISTED IN THE DEVICE RISK ASSESSMENT MATRIX AND IFU IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. THIS KNOWN PT EFFECT IS NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY ISSUE. IN REVIEW OF THE INCIDENT AND THE INVOLVED DEVICE, A CONCLUSIVE ROOT CAUSE CANNOT BE DETERMINED FOR THE REPORTED PT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY. THE MANUFACTURING RECORDS WERE REVIEWED AND THERE WERE NO NON-CONFORMING MATERIAL REPORTS ISSUED FOR THIS PART/LOT NUMBER COMBINATION AND ALL ON-LINE INSPECTION AND TESTING MET MANUFACTURING CRITERIA. IN ADDITION, A QUARY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED WITH THIS PART AND LOT NUMBER COMBINATION, WHICH SUGGESTS THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY ISSUE. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: DISSECTION REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE PROCEDURE INVOLVED A LESION THAT HAD MILD TORTUOSITY, WITH MILD CALCIFICATION, AND A 90% STENOSIS. AFTER PRE-DILATATION, THE 4.0 X 08 MM VISION STENT DELIVERY SYSTEM (SDS) WAS DELIVERED TO THE LESION AND THE BALLOON WAS INFLATED AT 16 ATM. THEN, A DISSECTION OCCURRED AND IT WAS CONFIRMED THAT THE STENT WAS NOT SEEN. THE VESSEL WAS THOROUGHLY SEARCHED, BUT THE STENT WAS NOT LOCATED. THE STENT WAS FINALLY FOUND INSIDE THE PROTECTIVE SHEATH. A 4.0 X 15MM VISION STENT WAS IMPLANTED TO TREAT THE DISSECTION AND ANOTHER COMPANY'S 3.5 X 23 MM STENT WAS IMPLANTED IN A DIFFERENT LESION. 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 704173Q

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention DIL CATH: ROSSO| GUIDE WIRE: WHISPER| 3.5-23 MM DURAFLEX| GUIDE CATH: MACH 1