BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTA V12 COVERED STENT

    MDR report key: 10589711 · Received September 25, 2020

    Report

    Report Number
    3011175548-2020-01166
    Event Type
    Malfunction
    Date Received
    September 25, 2020
    Date of Event
    September 14, 2020
    Report Date
    September 25, 2020
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    NIO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION B3 AND D4.

    Additional Manufacturer Narrative · 0

    BASED ON THE DETAILS OF THE COMPLAINT THE 8MM X 59MM STENT DISLODGED OFF THE BALLOON AT SOME POINT AFTER THE STENT DELIVERY SYSTEM WAS REMOVED FROM THE CATHETER TRAY. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PROCEDURE IN ORDER TO ASSIST WITH THE COMPLAINT INVESTIGATION. BECAUSE NONE OF THE QUESTIONS WERE ANSWERED, IT IS IMPOSSIBLE TO DETERMINE AT WHAT POINT PRIOR TO OR DURING THE PROCEDURE THAT THE STENT DISLODGED FROM ITS POSITION ON THE BALLOON. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND THIS PRODUCTION LOT OF CATHETERS AND SUB ASSEMBLY LOTS ASSOCIATED WITH THE FINISHED GOOD LOT NUMBER PASSED ALL PRODUCT REQUIREMENTS INCLUDING THE STENT RETENTION (CRIMPED STENT SECUREMENT) OF THE CRIMPED STENT TO THE BALLOON. THE MINIMUM STENT RETENTION VALUE RECORDED WAS 8.95 NEWTON¿S (N). THE PRODUCT REQUIREMENT AS DETAILED WITHIN THE PRODUCT REQUIREMENTS DOCUMENT STATES THAT THE STENT MUST NOT DETACH FROM THE BALLOON AT A VALUE LESS THAN 5.5 N OUT OF THE BOX. IN THIS REGARD, THE PRODUCTION LOT OF CATHETERS EXCEEDED THIS REQUIREMENT. IT IS ALSO IMPORTANT TO NOTE THAT DURING THE PRODUCT LOT PERFORMANCE TESTING THAT EVERY LOT OF CATHETERS IS SUBJECTED TO, A SAMPLING OF FINISHED DEVICES ARE PASSED THROUGH A INTRODUCER SHEATH TO ENSURE THE STENT IS SECURE ON THE BALLOON. THE DEVICE HISTORY RECORDS SHOW THAT ALL SAMPLES WERE PASSED THROUGH A 7FR INTRODUCER SHEATH WITHOUT AND MOVEMENT OF THE STENT OR DISLODGEMENTS. AS THE DETAILS PROVIDED DO NOT INDICATE AT WHAT POINT THE STENT CAME OFF THE BALLOON IT IS IMPOSSIBLE TO DETERMINE THE CAUSE OF THE STENT DISLODGEMENT. CAUSE COULD BE RELATED TO THE SIZE OF THE INTRODUCER SHEATH USED IN THE CASE AS THE PRODUCT LABEL SPECIFIES THE USE OF THE 8MM X 59MM X 80CM CATHETER WITH A 7FR INTRODUCER SHEATH AS SPECIFIED ON THE PRODUCT LABEL. THERE IS ALSO A POSSIBILITY THAT THERE WAS A LESION IN WHATEVER VESSEL THAT WAS BEING TREATED THAT WAS OF A SMALLER DIAMETER THAN THAT OF THE CRIMPED STENT. IT IS POSSIBLE THAT TOO MUCH FORCE WAS APPLIED IN TRYING TO CROSS THE LESION. IN THIS REGARD, THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: STEP 7. DO NOT REMOVE, REPOSITION OR HAND CRIMP THE STENT. STEP 8. DO NOT HANDLE OR IN ANY WAY DISRUPT THE PLACEMENT OF THE STENT ON THE BALLOON. STEP 9. THE DELIVERY SYSTEM IS NOT DESIGNED FOR USE WITH POWER INJECTION SYSTEMS. STEP 10. DO NOT FORCE PASSAGE OR WITHDRAWAL OF THE GUIDEWIRE OR DELIVERY SYSTEM IF RESISTANCE IS ENCOUNTERED. BASED ON THE INFORMATION PROVIDED, THE LACK OF DETAILS AFTER MULTIPLE GOOD FAITH EFFORTS TO OBTAIN MORE INFORMATION AND THE RESULTS OF THE INVESTIGATION THE COMPLAINT CANNOT BE CONFIRMED. H3 OTHER TEXT: NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    ON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENT DETACHED FROM BALLOON PRIOR TO IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055172 ADVANTA V12 COVERED STENT STENT, ILIAC NIO ATRIUM MEDICAL CORPORATION 85327 459135

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR