BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVIATOR PLUS PTA DILATATION CATHETER

    MDR report key: 3574413 · Received January 14, 2014

    Report

    Report Number
    9616099-2014-00036
    Event Type
    Injury
    Date Received
    January 14, 2014
    Date of Event
    October 31, 2013
    Report Date
    December 9, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LIT
    PMA / PMN Number
    K071189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT #1016427-2014-00007 AND 9616099-2014-00036.

    Additional Manufacturer Narrative · 1

    AS REPORTED BY THE (B)(4) REGISTRY THE PRECISE PRO RX US CAROTID SYSTEM FAILED TO CROSS THE LESION. IT WAS ALSO NOTED THAT A GRADE B DISSECTION OCCURRED AT THE LESION, DURING PRE-DILATION. THE DISSECTION WAS COVERED AND TREATED BY THE PRECISE STENT WHICH WAS PLACED AT ITS INTENDED LOCATION. THE PATIENT IS A (B)(6) MALE. THE TARGET LESION LOCATION WAS THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY. THE VESSEL WAS DESCRIBED AS SEVERELY CALCIFIED AND MILDLY TORTUOUS. THE RATE OF STENOSIS WAS 90%. AN ANGIOGUARD (801814REC/ LOT 7071244) EMBOLIC PROTECTION DEVICE WAS ADVANCED AND DEPLOYED DISTAL TO THE LESION. THE LESION WAS PRE-DILATED WITH AN AVIATOR (5 X 30) BALLOON. DURING PRE-DILATION A GRADE B DISSECTION WAS NOTED AT THE LESION. THE PHYSICIAN ATTEMPTED TO PLACE A PRECISE STENT IN THE LESION, BUT IT WOULD NOT CROSS. THEREFORE THE PRECISE WAS REMOVED AND ANOTHER PRECISE STENT WAS PLACED AND THE LESION WAS SUCCESSFULLY TREATED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PATIENT WAS DISCHARGED THE NEXT DAY. THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND TESTING. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. VESSEL DISSECTION IS A KNOWN PROCEDURAL COMPLICATION AND AN INHERENT RISK OF THIS TYPE OF PROCEDURE AND DOES NOT REPRESENT DEVICE MALFUNCTION. VESSEL CHARACTERISTICS AND/OR PROCEDURAL FACTORS (SUCH AS WIRE MANIPULATION AND PRE-DILATION OF THE VESSEL WALL) MAY CONTRIBUTE TO DISSECTION. THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT IS RELATED TO A MANUFACTURING ISSUE OR ANY DEFECT OF THE DEVICE. THE EXACT CAUSE OF THE REPORTED FAILURE TO CROSS COULD NOT BE DETERMINED, BUT PATIENT AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT. DHR REVIEW CONFIRMED THAT THE PRODUCT MET SPECIFICATIONS. NEITHER THE DHR NOR THE INFORMATION AVAILABLE FOR REVIEW INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 1016427-2014-00007 AND 9616099-2014-00036.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(4) REGISTRY THE PRECISE PRO RX US CAROTID SYSTEM FAILED TO CROSS THE LESION. IT WAS ALSO NOTED THAT A GRADE B DISSECTION OCCURRED AT THE LESION, DURING PRE-DILATION. THE DISSECTION WAS COVERED AND TREATED BY THE PRECISE STENT WHICH WAS PLACED AT ITS INTENDED LOCATION. THE PATIENT IS A (B)(6) MALE. THE TARGET LESION LOCATION WAS THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY. THE VESSEL WAS DESCRIBED AS SEVERELY CALCIFIED AND MILDLY TORTUOUS. THE RATE OF STENOSIS WAS 90%. AN ANGIOGUARD (801814REC/ LOT 7071244) EMBOLIC PROTECTION DEVICE WAS ADVANCED AND DEPLOYED DISTAL TO THE LESION. THE LESION WAS PRE-DILATED WITH AN AVIATOR (5 X 30) BALLOON. DURING PRE-DILATION A GRADE B DISSECTION WAS NOTED AT THE LESION. THE PHYSICIAN ATTEMPTED TO PLACE A PRECISE STENT IN THE LESION, BUT IT WOULD NOT CROSS. THEREFORE THE PRECISE WAS REMOVED AND ANOTHER PRECISE STENT WAS PLACED AND THE LESION WAS SUCCESSFULLY TREATED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PATIENT WAS DISCHARGED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36844 AVIATOR PLUS PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS DE MEXICO NA 15960111

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R ANGIOGUARD