BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVERED CP STENT

    MDR report key: 10489103 · Received September 3, 2020

    Report

    Report Number
    1318694-2020-00008
    Event Type
    Injury
    Date Received
    September 3, 2020
    Date of Event
    July 2, 2020
    Report Date
    September 3, 2020
    Manufacturer
    NUMED, INC.
    Product Code
    PNF
    PMA / PMN Number
    P150028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NONE OF THE DEVICES WERE RETURNED FOR REVIEW. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO ISSUES WERE NOTED. THERE ARE NO OTHER COMPLAINTS ASSOCIATED WITH THIS STENT LOT NUMBER. THE PHYSICIAN PROVIDED ADDITIONAL INFORMATION VIA AN EMAIL. SHE STATED - "THE PROBLEM WAS THAT IMMEDIATELY BEHIND THE HOMOGRAFT THE PULMONARY BRACHES WENT PERPENDICULARLY AND THERE WAS HARDLY ANY SPACE, WHILE THE DISTAL END OF THE HOMOGRAFT HAD SEVERE NARROWING. MAYBE THAT IS WHY THE STENT MOVED." BASED ON THE ADDITIONAL INFORMATION AS WELL AS THE INFORMATION PREVIOUSLY PROVIDED, IT SEEMS THAT THE MIGRATION OF THE STENT WAS DUE TO PATIENT ANATOMY.

    Description of Event or Problem · 1

    NUMED RECEIVED A POST MARKET CLINICAL FOLLOW-UP REPORT FROM THE EU IN REGARDS TO A STENT MIGRATION. THE FULL WRITE-UP IS AS FOLLOWS: STENOTIC PULMONARY HOMOGRAFT, 28MM, COMPLEX ANATOMY, HOMOGRAFT STENOTIC AT DISTAL END. DIRECTLY AFTER STENOTIC PART IN 90 DEGREE ANGLE ARE THE OSTIA OF PULMONARY ARTERIES. PLAN: PRESTENTING AND MELODY VALVE. AFTER BALLOON SIZING, PRESTENT 39MM 10 ZIG ON 28MM BIB BALLOON. INNER BALLOON INFLATED FIRST. GOOD DEPLOYMENT STENT, HOWEVER, STENT DISLOCATED TO PROXIMAL RVOT DIRECTION AND IS UNSTABLE. SECOND STENT, COVERED 49MM 10 ZIG ON 30MM BIB BALLOON. PLACED IN FIRST STENT IN HOMOGRAFT/RVOT, BUT NOT STABLE: SECOND STENT IS FIXED NICELY ON DISTAL HOMOGRAFT BUT FIRST STENT MOVED FURTHER IN RVOT. THIRD STENT 49MM 10 ZIG UNCOVERED ON BIB BALLOON 30MM PLACED BETWEEN BOTH STENTS, TRYING TO STABILIZE FIRST TWO STENTS. IN THE FIRST PLACE IT SEEMS TO BE A STABLE ENSEMBLE OF 3 STENTS, BUT SOME MINUTES LATER THE TWO PROXIMAL STENTS DISLOCATE TO RV (STILL ON WIRE). PATIENT WENT FOR SURGERY (WIRE IN PLACE), WHERE STENTS WERE REMOVED AND HOMOGRAFT REPLACED BY OTHER HOMOGRAFT. GOOD RESULT. PATIENT RECOVERED COMPLETELY. CONCLUSION: AT PRESTENTING STENOTIC HOMOGRAFT (DIFFICULT ANATOMY) DISLOCATION OF STENT 39MM 10ZIG RVOT. EFFORTS TO STABILIZE STENT IN HOMOGRAFT WITH TWO MORE STENTS WAS NOT SUCCESSFUL. STENTS COULD BE DEPLOYED NICELY. ALL STENT WERE FULLY EXPANDED. NO ISSUE WITH STENT 2 OR 3 WHICH WERE USED FOR RESCUE EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952412 COVERED CP STENT AORTIC STENT PNF NUMED, INC. 427 CCP-1092

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention