BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 1932138 · Received December 17, 2010

    Report

    Report Number
    2024168-2010-02801
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 24, 2010
    Manufacturer
    AV-CLONMEL
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). BALLOON MATERIAL RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, HANDLING, LESION CALCIFICATION AND TORTUOSITY, AN INTERACTION WITH A PREVIOUSLY IMPLANTED STENT, INSUFFICIENT PREPARATION PRIOR TO USE OR FROM INTERACTIONS WITH OTHER DEVICES. NO PATIENT ANATOMICAL INFORMATION WAS PROVIDED, WHICH MAY HAVE AIDED THE INVESTIGATION. ANALYSIS OF THE RETURNED PRODUCT NOTED CONTRAST VISIBLE IN THE INFLATION LUMEN AND THE LOOSELY-FOLDED BALLOON, SUGGESTING THAT THE DEVICE WAS PREPARED FOR USE AND PRESSURIZED DURING THE PROCEDURE, AS REPORTED. THERE WAS ALSO BLOOD VISIBLE IN THE BALLOON WHICH IS CONSISTENT WITH A LEAK OR BALLOON RUPTURE. A NEW INDEFLATOR WAS USED IN AN ATTEMPT TO PRESSURIZE THE BALLOON AND THE ANALYSIS CONFIRMED THAT THERE WAS A PINHOLE IN THE BALLOON LOCATED WITHIN A CRIMP MARK, 1CM PROXIMAL TO THE DISTAL BALLOON SHOULDER. THE BALLOON DID NOT EXHIBIT ANY TRACES OF MECHANICAL DAMAGE (SCRATCHES), THEREFORE, IT WAS SENT TO THE SCANNING ELECTRON MICROSCOPY (SEM) LAB FOR FURTHER ANALYSIS. THE SEM ANALYSIS CONFIRMED THE REPORTED LEAK AT THE DISTAL END OF A STRUT IMPRESSION AND DETERMINED THAT THE BALLOON FAILURE MAY HAVE BEEN ATTRIBUTED TO MECHANICAL DAMAGE TO THE OUTER SURFACE. THERE WAS MECHANICAL DAMAGE OBSERVED AT THE LEAK EDGES AND AWAY FROM THE LEAK. IN THIS CASE, DUE TO THE LOCATION OF THE RUPTURE, IT IS POSSIBLE THAT THE LEAK MAY BE RELATED TO AN INTERACTION WITH THE STENT DURING MANUFACTURING, ALTHOUGH THE EXACT CAUSE CANNOT BE DETERMINED. ANALYSIS ALSO NOTED TWO KINKS IN THE HYPOTUBE AND A KINK IN THE DISTAL SHAFT 1CM DISTAL TO THE GUIDE WIRE EXIT NOTCH. ALTHOUGH THE KINKS WERE NOT REPORTED, THIS DAMAGE LIKELY OCCURRED FROM FURTHER HANDLING AFTER THE PROCEDURE AS THE DEVICE WAS PACKAGED FOR SHIPMENT BACK TO ABBOTT VASCULAR FOR ANALYSIS. THIS DAMAGE DOES NOT APPEAR TO BE RELATED TO OR HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND ALL LOT RELEASE TESTING FOR BALLOON RUPTURE PRESSURE MET MANUFACTURING CRITERIA. FURTHERMORE, A QUERY OF THE COMPLAINT-HANDLING DATABASE DID NOT REVEAL ANY OTHER INCIDENTS REPORTED FOR A BALLOON RUPTURE FROM THIS LOT, SUGGESTING THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES. IN THIS INSTANCE, ALTHOUGH A DEFINITIVE CAUSE FOR THE REPORTED BALLOON RUPTURE CANNOT BE DETERMINED, MANUFACTURING WILL BE NOTIFIED OF THIS INCIDENT FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A MINI VISION STENT WAS DEPLOYED IN THE DISTAL CIRCUMFLEX, ANOTHER MINI VISION STENT WAS TO BE DEPLOYED IN THE PROXIMAL CIRCUMFLEX. HOWEVER, WHEN THE SECOND MINI VISION WAS DEPLOYED IN THE PROXIMAL CIRCUMFLEX, THERE WAS A BALLOON RUPTURE AT 12 ATMOSPHERES. THE STENT DEPLOYED FINE AND THERE WAS NO PATIENT INJURY. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS 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-CLONMEL 0082041

    Patients

    Seq Age Sex Outcome Treatment
    1 MINI VISION STENT