BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROADSAVER 5F

    MDR report key: 21612113 · Received March 14, 2025

    Report

    Report Number
    2032493-2025-00224
    Event Type
    Injury
    Date Received
    March 14, 2025
    Date of Event
    January 16, 2025
    Report Date
    May 2, 2025
    Manufacturer
    MICROVENTION INC.
    Product Code
    NIM
    UDI-DI
    00811425024799
    PMA / PMN Number
    P210030
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: PLEASE NOTE THIS MDR WAS ORIGINALLY SUBMITTED IN ERROR AS ONLY A PRODUCT PROBLEM. B1, B2, AND H1 WERE CORRECTED TO REFLECT SERIOUS INJURY AS INCIDENT DETAILS INDICATE / DETERMINE. ALL OTHER PREVIOUSLY SUBMITTED DATA REMAINS CORRECT. INVESTIGATION CONCLUSION: THE PHYSICAL DEVICE WAS NOT PROVIDED FOR EVALUATION; HOWEVER, AN IMAGE OF THE DEVICE WAS PROVIDED FOR REVIEW. THE PROVIDED IMAGE SHOWS THAT A PORTION OF THE GUIDEWIRE LUMEN AND THE SOFT TIP WERE SEPARATED FROM THE DELIVERY SYSTEM, WHICH IS CONSISTENT WITH THE CONDITION DESCRIBED IN THE REPORTED EVENT. THE CATHETER DISTAL TIP APPEARED FLATTENED, WHICH WOULD HAVE CONTRIBUTED TO THE REPORTED RESISTANCE AND WOULD HAVE OBSTRUCTED THE RETRIEVAL OF THE DELIVERY SYSTEM. HOWEVER, AS NO PROCEDURE IMAGING OF THE STENT IMPLANT WAS PROVIDED, THIS INVESTIGATION COULD NOT VERIFY THE ALLEGED EXPANSION ISSUE OR THE REPORTED OCCLUSION.

    Additional Manufacturer Narrative · 0

    A SEARCH FOR NON-CONFORMANCE'S ASSOCIATED WITH THE REPORTED PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. PROCEDURAL NOTES WERE NOT PROVIDED; HOWEVER, IMAGING WAS RECEIVED. THE ALLEGED PRODUCT ISSUE COULD NOT BE CONFIRMED AT THIS TIME. HOWEVER, THE INVESTIGATION IS ONGOING. UPON COMPLETION, OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED, PLEASE SEE H6 & H11.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A ROADSAVER STENT WAS IMPLANTED AND DID NOT FULLY EXPAND; A BALLOON WAS UNABLE TO ADVANCE THROUGH IT TO REACH THE LESION SITE. THE FILTER BEING USED WITH THE DEVICE COULD NOT BE REMOVED THROUGH THE LUMEN AND SO EVERYTHING WAS REMOVED AS ONE UNIT; OUTSIDE OF THE PATIENT, THE HYPOTUBE OF THE ROADSAVER APPEARED LOOSE NEAR THE TIP. AFTERWARDS, ANGIOGRAPHY SHOWED STENT OCCLUSION. A CATHETER AND A GUIDEWIRE WERE PASSED THROUGH THE STENT AGAIN AND POST-DILATION WAS PERFORMED WITH A BALLOON. FLOW WAS COMPLETELY RESTORED AND THERE WAS NO EVIDENCE OF DISTAL THROMBOEMBOLISM. IT WAS REPORTED THAT THE PATIENT DIED SIX DAYS POST PROCEDURE DUE TO RESPIRATORY FAILURE AFTER NOT TOLERATING EXTUBATION. IT DOES NOT APPEAR THAT THERE IS A LINK BETWEEN THE DEVICE AND THE PATIENT'S DEATH FROM RESPIRATORY FAILURE. ADDITIONAL INFORMATION RECEIVED PROVIDED THE FOLLOWING: OPERATIVE REPORT IS NOT AVAILABLE. THE ROADSAVER WAS IN THE RIGHT ICA. THE PATIENT HAD A STROKE THREE DAYS BEFORE THE PROCEDURE WITH TOTAL OCCLUSION OF THE LEFT ICA. SINCE THE PATIENT NEUROLOGICAL SITUATION WAS GETTING WORSE, THEY DECIDED TO TREAT THE CONTRALATERAL STENOSIS. PREVIOUS ANALYTICAL RESULTS SHOWED THAT HE HAD AN ACTIVE LEUKOCYTOSIS. WE THINK IS OFF LABEL BECAUSE THEY USED A 6FR GUIDING SHEATH INSTEAD OF A 7FR ONE. THERE IS NO ALLEGED LINK BETWEEN THE ROADSAVER AND THE PATIENT'S DEATH. THE CUSTOMER CLAIMS THAT THERE WAS AN OCCLUSION OF THE STENT JUST AFTER STENT IMPLANTATION, IT WAS RESOLVED BY BALLOON POSTDILUTION SHOWING NO THROMBOEMBOLISM AS A RESULT OF THIS. THERE WAS OCCLUSION IN THE STENT. NO TYPE OF MEDICATION ADMINISTERED DUE TO THE OCCLUSION. IT WASN'T A THROMBUS, IT WAS AN OCCLUSION, PROBABLY BECAUSE THE STENT WASN'T FULLY EXPANDED. EVERYTHING WAS REMOVED AT THE SAME TIME, FILTER WITH GUIDEWIRE, THE RAPID EXCHANGE DISTAL PART OF STENT, BALLOON AND GUIDE-CATHETER. IMAGING WAS PROVIDED FOR REVIEW, AND THE INVESTIGATION IS CURRENTLY IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642024 ROADSAVER 5F STENT CAROTID NIM MICROVENTION INC. RDS-0725-143RX 0000392603 00811425024799

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention