BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUENCY PLUS VASCULAR STENT GRAFT

    MDR report key: 22836724 · Received August 19, 2025

    Report

    Report Number
    9681442-2025-00252
    Event Type
    Malfunction
    Date Received
    August 19, 2025
    Date of Event
    May 15, 2025
    Report Date
    September 3, 2025
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG -9681442
    Product Code
    PFV
    PMA / PMN Number
    P130029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: THE CATALOG NUMBER IDENTIFIED IN SECTION D4 HAS NOT BEEN CLEARED IN THE US BUT IS SIMILAR TO THE FLUENCY PLUS ENDOVASCULAR STENT GRAFT PRODUCTS THAT ARE CLEARED IN THE US. THE PRO CODE AND 510 K NUMBER FOR THE FLUENCY PLUS ENDOVASCULAR STENT GRAFT PRODUCTS ARE IDENTIFIED IN D2 AND G4. AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. HOWEVER, PHOTOS WERE PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. SECTION A THROUGH F ¿ THE INFORMATION PROVIDE BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Additional Manufacturer Narrative · 0

    H11: THE CATALOG NUMBER IDENTIFIED IN SECTION D4 HAS NOT BEEN CLEARED IN THE US BUT IS SIMILAR TO THE FLUENCY PLUS ENDOVASCULAR STENT GRAFT PRODUCTS THAT ARE CLEARED IN THE US. THE PRO CODE AND 510 K NUMBER FOR THE FLUENCY PLUS ENDOVASCULAR STENT GRAFT PRODUCTS ARE IDENTIFIED IN D2 AND G4. MANUFACTURING REVIEW: THE LOT HISTORY RECORDS OF LOT ANHZ1214 WERE REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT AND THE PRODUCT. BASED ON THIS REVIEW THE PRODUCTS OF THIS LOT WERE FOUND TO HAVE MET THE SPECIFICATION PRIOR TO SHIPMENT. INVESTIGATION SUMMARY: THE STENT GRAFT DELIVERY SYSTEM WAS NOT RETURNED FOR EVALUATION. TWO PHOTOS WERE PROVIDED SHOWING A STENT GRAFT DELIVERY SYSTEM WITH THE LOT NUMBER ANHZ1214, PLACED ON AN ORIGINAL PACKAGING OF ANOTHER LOT. THE DELIVERY SYSTEM WITH THE LOT NUMBER ANHZ1214 CONTAINS THE STENT GRAFT PARTIALLY DEPLOYED. BASED ON THE PHOTO NO INDICATION FOR A MANUFACTURING RELATED CAUSE COULD BE FOUND. THEREFORE, THE RESULT OF THE INVESTIGATION, IT WAS REPORTED THAT A 10F INTRODUCER WAS USED WITH A 0.035" GUIDEWIRE WAS USED FOR ACCESS, THE TRACKING VESSEL WAS NOT TORTUOUS BUT MILDLY CALCIFIED AND THE DEVICE WAS FLUSHED. BASED ON INFORMATION AVAILABLE AND REVIEW OF PHOTOS PROVIDED, INCOMPLETE STENT GRAFT DEPLOYMENT IS CONFIRMED. HOWEVER, A DEFINITE ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. LABELLING REVIEW: IN REVIEWING THE RELEVANT LABELING, IT WAS FOUND THAT THE INSTRUCTIONS FOR USE (IFU) SUFFICIENTLY ADDRESS THE POTENTIAL RISKS. THE IFU STATES: IF EXCESSIVE FORCE IS FELT DURING STENT GRAFT DEPLOYMENT, DO NOT FORCE THE DELIVERY SYSTEM. REMOVE THE DELIVERY SYSTEM AND REPLACE WITH A NEW UNIT. REGARDING PREPARATION OF THE DEVICE THE IFU STATES: PRIOR TO LOADING THE DELIVERY SYSTEM OVER A GUIDE WIRE, BOTH PORTS MUST BE FLUSHED WITH STERILE SALINE TO ELIMINATE ANY AIR BUBBLES THAT MAY BE TRAPPED IN THE INNER CATHETER LUMEN AND/OR THE STENT GRAFT LUMEN. FLUSHING THESE LUMENS WILL ALSO FACILITATE STENT GRAFT DEPLOYMENT. REGARDING MATERIALS, AN APPROPRIATE INTRODUCER SHEATH AND A 0.035-INCH (0.89 MM) DIAMETER SUPER STIFF GUIDEWIRE IS REQUIRED FOR THE PROCEDURE. THE PACKAGING PICTOGRAMS INDICATE AN INTRODUCER SIZE OF 9F AND A 0.035 GUIDEWIRE. IT IS STATED IN THE IFU THAT PRE-DILATATION OF THE STENOTIC LESION MAY BE PERFORMED PRIOR TO STENT GRAFT DEPLOYMENT AT THE DISCRETION OF THE TREATING PHYSICIAN". B5, G3, H6 (METHOD, RESULT, CONCLUSION). SECTION A THROUGH F ¿ THE INFORMATION PROVIDE BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A PATIENT UNDERWENT A STENT GRAFT PLACEMENT PROCEDURE USING FLUENCY STENT GRAFT IN THE RIGHT ILIAC ARTERY AND BALLOON DILATATION OF THE RIGHT LOWER EXTREMITY ARTERY UNDER LOCAL ANESTHESIA. DURING THE PROCEDURE, THE STENT DEPLOYMENT SYSTEM JAMMED AND COULD NOT BE FULLY DEPLOYED IN THE BODY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING FLUENCY STENT GRAFT OF THE RIGHT ILIAC ARTERY IN FEMORAL ARTERY AND BALLOON DILATATION OF THE RIGHT LOWER EXTREMITY ARTERY UNDER LOCAL ANESTHESIA. DURING THE PROCEDURE, THE STENT DEPLOYMENT SYSTEM JAMMED AND COULD NOT BE FULLY DEPLOYED IN THE BODY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1865561 FLUENCY PLUS VASCULAR STENT GRAFT VASCULAR STENT GRAFT PFV ANGIOMED GMBH & CO. MEDIZINTECHNIK KG -9681442 ANHZ1214

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown