BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUENCY PLUS VASCULAR STENT GRAFT

    MDR report key: 23107968 · Received September 22, 2025

    Report

    Report Number
    9681442-2025-00313
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    September 1, 2025
    Report Date
    November 24, 2025
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    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 THAT ARE CLEARED IN THE US. THE PRO CODE AND 510 K NUMBER FOR THE FLUENCY PLUS ENDOVASCULAR STENT GRAFT ARE IDENTIFIED IN D2 AND G4. MANUFACTURING REVIEW: BASED ON THE INFORMATION AVAILABLE IT IS NOT REASONABLY SUGGESTED THAT A MANUFACTURING PROCESS MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. HOWEVER, THE LOT HISTORY RECORDS OF THIS LOT WERE REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT AND THE PRODUCT WAS FOUND TO HAVE MET THE SPECIFICATION PRIOR TO SHIPMENT. INVESTIGATION SUMMARY: THE DELIVERY SYSTEM SAMPLE WAS NOT RETURNED FOR EVALUATION BUT PROVIDED VIDEOS SHOW PLACED STENTS WITH VISIBLE RADIO-OPAQUE MARKERS AND CONTRASTED BLOOD FLOWING THROUGH. NO VISIBLE DAMAGE IS FOUND ON THE STENTS. SINCE THE DELIVERY SYSTEM SAMPLE WAS NOT RETURNED FOR EVALUATION, A DETACHMENT OF THE DELIVERY SYSTEM CANNOT BE EVALUATED WHICH LEADS TO INCONCLUSIVE RESULTS FOR PARTIAL DEPLOYMENT AND DETACHMENT. THERE WERE NO INDICATIONS OF MANUFACTURING DEFICIENCIES. IN THIS CASE, IT WAS REPORTED THAT AN 8F INTRODUCER WAS USED WITH A 0.035" GUIDEWIRE FOR ACCESS, THE TRACKING VESSEL HAD NO SEVERE CURVATURE BUT WAS CALCIFIED, THE STENT DELIVERY SYSTEM WAS FOUND TO BE DETACHED WHEN IT WAS REMOVED FROM THE BODY AND THE LESION WAS PRE-DILATED. IT IS NOT EVEN CLEAR WHICH PART OF THE DELIVERY SYSTEM GOT DETACHED. BASED ON THE PROVIDED INFORMATION AND EVALUATION OF THE PROVIDED VIDEOS, THE INVESTIGATION IS CLOSED WITH INCONCLUSIVE RESULTS FOR PARTIAL STENT GRAFT DEPLOYMENT AND DETACHMENT. A DEFINITE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. LABELING REVIEW: IN REVIEWING THE RELEVANT LABELING, IT WAS FOUND THAT THE INSTRUCTIONS FOR USE (IFU) SUFFICIENTLY ADDRESS THE POTENTIAL RISKS. REGARDING ANATOMY 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" ARE REQUIRED FOR THE PROCEDURE. THE PACKAGING PICTOGRAMS INDICATE AN INTRODUCER SIZE OF 8F 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". G3, H6 (METHOD, RESULT, CONCLUSION) SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF 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 THAT ARE CLEARED IN THE US. THE PRO CODE AND 510 K NUMBER FOR THE FLUENCY PLUS ENDOVASCULAR STENT GRAFT 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 RETURN OF THE SAMPLE IS PENDING. HOWEVER, VIDEOS WERE PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF 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 WITH A STENOTIC OCCLUSION IN THE ILIAC-TO-COMMON FEMORAL ARTERY SEGMENT IN LOWER EXTREMITY UNDERWENT A PLANNED BALLOON ANGIOPLASTY USING A FLUENCY STENT. DURING THE PROCEDURE, THE INITIAL STENT FAILED TO FULLY DEPLOY AFTER THE FIRST 1¿2 CM. DESPITE MULTIPLE ATTEMPTS, EXPANSION WAS UNSUCCESSFUL, AND THE STENT WAS RETRIEVED. IT WAS FURTHER REPORTED THAT THE STENT DELIVERY SHEATH WAS DETACHED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A PATIENT WITH A STENOTIC OCCLUSION IN THE ILIAC-TO-COMMON FEMORAL ARTERY SEGMENT IN THE LOWER EXTREMITY UNDERWENT A PLANNED BALLOON ANGIOPLASTY USING A FLUENCY STENT. DURING THE PROCEDURE, IT WAS REPORTED THAT THE INITIAL STENT FAILED TO DEPLOY FULLY AFTER THE FIRST ONE TO TWO CENTIMETER. DESPITE MULTIPLE ATTEMPTS, EXPANSION WAS UNSUCCESSFUL, AND THE STENT WAS RETRIEVED. IT WAS FURTHER REPORTED THAT THE STENT DELIVERY SHEATH WAS DETACHED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2510843 FLUENCY PLUS VASCULAR STENT GRAFT VASCULAR STENT GRAFT PFV ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANKN3839

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown