BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVERA VASCULAR COVERED STENT

    MDR report key: 22456872 · Received July 9, 2025

    Report

    Report Number
    9681442-2025-00210
    Event Type
    Malfunction
    Date Received
    July 9, 2025
    Date of Event
    December 13, 2024
    Report Date
    June 19, 2025
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    PFV
    UDI-DI
    00801741106385
    PMA / PMN Number
    P170042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: MANUFACTURING REVIEW: 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. BASED ON THE INFORMATION AVAILABLE IT IS NOT REASONABLY SUGGESTED THAT A MANUFACTURING PROCESS MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. INVESTIGATION SUMMARY: THE DELIVERY SYSTEM WAS NOT RETURNED FOR EVALUATION, THE STENT REMAINS IMPLANTED. BASED ON X-RAY IMAGES PROVIDED COLLAPSE OF THE DISTAL END OF THE STENT IS CONFIRMED. BASED ON INFORMATION AVAILABLE, COLLAPSE OF THE DISTAL END OF THE STENT IS CONFIRMED. HOWEVER, NO DAMAGE OR STRUCTURAL DEFECTS OF THE STENT CAN BE IDENTIFIED. A DEFINITE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. LABELING REVIEW: RELEVANT LABELING FOR THIS PRODUCT WAS REVIEWED. POTENTIAL COMPLICATIONS AND ADVERSE EVENTS WERE FOUND TO BE REFERENCED. THE INSTRUCTIONS FOR USE STATES THAT POTENTIAL COMPLICATIONS MAY INCLUDE BUT ARE NOT LIMITED TO: NEW LESIONS IN THE ACCESS CIRCUIT REQUIRING REINTERVENTION, THROMBOTIC OCCLUSION, RESTENOSIS OF THE TARGET LESION REQUIRING REINTERVENTION AND OTHERS. COVERED STENT SPECIFIC EVENTS THAT COULD BE ASSOCIATED WITH CLINICAL COMPLICATIONS SUCH AS MISPLACEMENT, MIGRATION, EMBOLISM, FRACTURE, COMPRESSION, KINKING AND INSUFFICIENT COVERED STENT EXPANSION. INSTRUCTIONS FOR COVERED STENT DEPLOYMENT WERE FOUND TO BE DESCRIBED IN THE INSTRUCTIONS FOR USE, E.G., "MAINTAIN A STATIONARY HOLD ON THE WHITE STABILITY SHEATH DURING COVERED STENT DEPLOYMENT (¿). HOLD THE WHITE STABILITY SHEATH AS CLOSE AS POSSIBLE TO THE INTRODUCER WITHOUT TOUCHING THE DARK BROWN MOVING CATHETER OF THE DISTAL CATHETER ASSEMBLY. MAINTAIN THE REMAINDER OF THE WHITE STABILITY SHEATH (...) RELAXED AND AVOID TENSION. REGARDING CHOOSING THE SIZE OF THE COVERED STENT, THE INSTRUCTIONS FOR USE STATES: "SPECIAL CARE MUST BE TAKEN TO ENSURE THAT AN APPROPRIATELY SIZED DEVICE IS SELECTED. IN THE CASE OF A DIAMETER DIFFERENCE BETWEEN THE INFLOW AND THE OUTFLOW END, UTILIZE THE FOLLOWING AS THE REFERENCE VESSEL DEPENDING ON THE TYPE OF ACCESS. FOR AN AV GRAFT ACCESS, UTILIZE THE GRAFT DIAMETER AND FOR AN AV FISTULA ACCESS, UTILIZE THE INFLOW VEIN DIAMETER." 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

    IT WAS REPORTED THAT A PATIENT'S FISTULA WAS FOUND CLOTTED IN LESS THAN ONE MONTH AFTER PLACEMENT OF THE STENT. IT WAS IDENTIFIED THAT THE PERIPHERAL END OF STENT WAS COLLAPSED AND IT WAS EXTREMELY DIFFICULT TO PASS THE WIRE INTO CENTRAL VEINS. ANGIOPLASTY WAS PERFORMED OF THE COLLAPSED STENT USING A 10MM ANGIOPLASTY BALLOON TO STRAIGHTENED THE STENT. ANOTHER BRAND STENT WAS PLACED WITH GOOD RESULT ON BOTH ANGIOGRAM AND PHYSICAL EXAMINATION. THE PATIENT¿S FISTULA IS WORKING WELL DURING DIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120847 COVERA VASCULAR COVERED STENT VASCULAR COVERED STENT PFV ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANJP3186 00801741106385

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male