BEUDAMED
    FDA Adverse Event Death Summary report: N

    WEB LOW PROFILE SL-USA W4-4-3FOR US

    MDR report key: 9714819 · Received February 14, 2020

    Report

    Report Number
    2032493-2020-00033
    Event Type
    Death
    Date Received
    February 14, 2020
    Date of Event
    February 10, 2020
    Report Date
    February 10, 2020
    Manufacturer
    SEQUENT MEDICAL, INC.
    Product Code
    OPR
    UDI-DI
    00854111006044
    PMA / PMN Number
    P170023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION RECEIVED ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT DIED ON (B)(6) 2020 AFTER THE PATIENT'S FAMILY ELECTED TO DISCONTINUE LIFE SUPPORT. ADDITIONAL DATA: (B2). ADDITIONAL DATA: (H1). THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES DEATH AS A POTENTIAL COMPLICATION ASSOCIATED WITH THE USE OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL/CLARIFYING INFORMATION RECEIVED FROM THE SALES REP ON 4/13/20: AFTER PLACEMENT OF THE WEB IN THE ANEURYSM, ANGIOGRAPHY DEMONSTRATED SIGNS OF NORMAL WEB COMPRESSION WITHIN THE ANEURYSM AS EXPECTED, CONSISTENT WITH AN APPROPRIATELY SIZED DEVICE. AT THE VERY END OF THE CASE, THE PATIENT WAS ROUSED FOR A NEURO CHECK AND SHE EXHIBITED SIGNS OF A STROKE. AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS TO REMOVE THE WEB WITH A STENTRIEVER, AN LVIS STENT WAS IMPLANTED TO PIN THE WEB TO THE VESSEL WALL, FOLLOWED BY IN-STENT INFLATIONS WITH A NON-MICROVENTION ANGIOPLASTY BALLOON. VESSEL DISSECTION WITH BLEEDING (EXTRAVASATION) WAS IDENTIFIED IMMEDIATELY AT THE SITE OF STENT IMPLANTATION. THE PHYSICIAN STATED THE CAUSE OF THE PATIENT'S DEATH WAS "PRESSURE BUILD-UP PUSHING DOWN ON THE BRAINSTEM, SECONDARY TO HEMORRHAGIC STROKE."

    Additional Manufacturer Narrative · 1

    A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THIS PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. THE WEB WAS IMPLANTED AND THE DELIVERY SYSTEM WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE CANNOT BE DETERMINED. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES DEVICE MIGRATION, HEMORRHAGE, PARENT ARTERY OCCLUSION, AND VESSEL DISSECTION OR PERFORATION AS POTENTIAL COMPLICATIONS ASSOCIATED WITH THE USE OF THE DEVICE. THE SUBMISSION OF THIS REPORT OR RELATED INFORMATION TO THE FDA, AND ITS RELEASE BY THE FDA, DOES NOT REFLECT A CONCLUSION BY THE PARTY SUBMITTING THIS REPORT OR THE FDA THAT THE REPORT OR RELATED INFORMATION IS AN ADMISSION THAT THE MANUFACTURER, THEIR EMPLOYEES, OR THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TREATMENT WAS PERFORMED FOR A RIGHT P-COM ANEURYSM ON A PATIENT UNDER CONSCIOUS SEDATION. AFTER UNEVENTFUL PLACEMENT OF THE WEB, IMAGING DEMONSTRATED A SMALL AMOUNT OF ENCROACHMENT OF THE PARENT VESSEL. DELAYED IMAGING DEMONSTRATED GOOD FLOW WITHIN THE PARENT ARTERY [RIGHT INTERNAL CAROTID (RICA)] AND DECREASED FLOW INTO THE ANEURYSM SAC. THE WEB WAS DETACHED APPROXIMATELY 7 MINUTES AFTER DEPLOYMENT. A SUBSEQUENT NEURO CHECK WAS PERFORMED AND THE PATIENT DEMONSTRATED WEAKNESS OF THE LEFT UPPER EXTREMITY. 3-D RECONSTRUCTION ANGIOGRAPHY DEMONSTRATED REDUCED FLOW IN THE RICA AND WEB MIGRATION FROM THE ANEURYSM SAC INTO THE DISTAL RIGHT MCA-M1 SEGMENT. THERE WAS TOTAL OCCLUSION OF THE RIGHT MCA BRANCHES AND OUTFLOW. ATTEMPTS WERE MADE WITH MULTIPLE DEVICES TO RETRIEVE THE WEB; HOWEVER, ALL EFFORTS WERE UNSUCCESSFUL. A STENT WAS IMPLANTED TO COMPRESS THE WEB AGAINST THE M1 VESSEL, AND IN-STENT BALLOON INFLATIONS WERE PERFORMED; HOWEVER, THERE WAS ONLY SLIGHT INCREASE IN FLOW. THE M1 VESSEL APPEARED TO HAVE A NEW VESSEL DISSECTION WITH ASSOCIATED EXTRAVASATION AT THE SITE OF THE BALLOON INFLATIONS. TEN (10) EMBOLIZATION COILS WERE IMPLANTED TO SACRIFICE THE PARENT VESSEL TO OCCLUDE THE EXTRAVASATION. FINAL ANGIOGRAM DEMONSTRATED TOTAL OCCLUSION OF THE MCA VESSEL AND OUTFLOW. THE PATIENT WAS INTUBATED AND TRANSFERRED TO THE NEURO-ICU. THE PATIENT IS REPORTED TO BE IN CRITICAL CONDITION AND STILL ON A VENTILATOR AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177050 WEB LOW PROFILE SL-USA W4-4-3FOR US INTRASACCULAR FLOW DISRUPTION DEVICE OPR SEQUENT MEDICAL, INC. FGA25040-030 19012816 00854111006044

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death| H| L| R| S