BEUDAMED
    FDA Adverse Event Death Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 2171753 · Received July 22, 2011

    Report

    Report Number
    2024168-2011-05077
    Event Type
    Death
    Date Received
    July 22, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE 2.5 X 12 MM RX MINI VISION AND THE 2.5 X 18 MM RX VISION ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS. THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. ANALYSIS IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE IN THE GUIDE WIRE LUMEN, CONSISTENT WITH THE STENT DELIVERY SYSTEM (SDS) ADVANCED OVER A GUIDE WIRE. THE STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS. THERE WERE TWO BENT STRUTS ON THE FIRST ROW AT THE PROXIMAL END OF THE STENT IMPLANT. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE STENT DAMAGE MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. THE TIP LENGTH AND STENT OUTER DIAMETERS WERE MEASURED AND MET MANUFACTURING CRITERIA. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. THE PATIENT ANATOMY WAS REPORTEDLY HEAVILY CALCIFIED, WHICH LIKELY CONTRIBUTED TO THE REPORTED FAILURE TO ADVANCE. ATRIAL FIBRILLATION (A FORM OF CARDIAC ARRHYTHMIA) AND DEATH ARE KNOWN ADVERSE EVENTS LISTED IN THE MINI VISION INSTRUCTIONS FOR USE (IFU). A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, COULD NOT BE DETERMINED. IT WAS REPORTED THE MINI VISION WAS ATTEMPTED TO BE USED TO TREAT A DISSECTION. IT SHOULD BE NOTED THE IFU STATES: THE MULTI-LINK MINI VISION RX AND MULTI-LINK MINI VISION OTW CORONARY STENT SYSTEMS ARE INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH ABRUPT OR THREATENED ABRUPT CLOSURE WITH FAILED INTERVENTIONAL THERAPY OF DE NOVO AND RESTENOTIC NATIVE CORONARY ARTERY LESIONS. IN THIS CASE, IT DOES NOT APPEAR THAT THE ATTEMPT TO TREAT A DISSECTION CONTRIBUTED TO THE REPORTED DIFFICULTIES. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THERE IS NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE REPORTED FAILURE TO ADVANCE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT REFUSED RECOMMENDED SURGERY AND CHOSE PERCUTANEOUS CORONARY INTERVENTION. DURING THE PERCUTANEOUS INTERVENTION IN THE LEFT ANTERIOR DESCENDING ARTERY, PRE-DILATATION WAS PERFORMED USING A 2.5 X 20 NON-ABBOTT BALLOON. A DISSECTION OCCURRED DURING DILATATION. THE DILATATION CATHETER WAS REMOVED FROM THE ANATOMY. AN ATTEMPT WAS MADE TO ADVANCE A 2.5 X 23 RX MINI VISION STENT SYSTEM FOR TREATMENT OF THE DISSECTION BUT DUE TO HEAVY CALCIFICATION, THE STENT SYSTEM COULD NOT CROSS. THE STENT SYSTEM WAS REMOVED FROM THE ANATOMY AND ADDITIONAL DILATATION WAS PERFORMED USING THE SAME BALLOON. AN UNSUCCESSFUL ATTEMPT WAS MADE TO ADVANCE A 2.5 X 18 RX MINI VISION STENT SYSTEM ADDITIONAL BALLOON DILATATION WAS PERFORMED AND A 2.5 X 12 RX MINI VISION STENT SYSTEM WAS ADVANCED BUT COULD NOT CROSS. DURING ADDITIONAL BALLOON DILATATION, THE PATIENT BECAME NAUSEOUS. THIRD DEGREE AV HEART BLOCK OCCURRED AND THE PATIENT DIED WHILE IN THE CATH LAB. THOUGH REQUESTED, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 1050441

    Patients

    Seq Age Sex Outcome Treatment
    1 Death STENTS: 2.5X12, 2.5X18 MINI VISION