BEUDAMED
    FDA Adverse Event Death Summary report: N

    WEB SL

    MDR report key: 16981533 · Received May 22, 2023

    Report

    Report Number
    2032493-2023-00743
    Event Type
    Death
    Date Received
    May 22, 2023
    Date of Event
    April 1, 2023
    Report Date
    April 30, 2023
    Manufacturer
    MICROVENTION, INC.
    Product Code
    OPR
    UDI-DI
    04987892122309
    PMA / PMN Number
    K020434
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 INSTRUCTIONS FOR USE (IFU) IDENTIFIES ANEURYSM RUPTURE AND DEATH AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE. THE DEVICE WAS IMPLANTED AND NOT AVAILABLE FOR RETURN AND ANALYSIS. IMAGING WAS PROVIDED AND WAS CONSISTENT WITH THE REPORTS REGARDING USE OF THE DEVICE. THE INVESTIGATION IS ONGOING. UPON COMPLETION OF THE INVESTIGATION, IF ADDITIONAL INFORMATION IS OBTAINED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. DEVICE WAS IMPLANTED IN PATIENT

    Additional Manufacturer Narrative · 0

    IMAGING REVIEW: CASE PRESENTATION WAS PROVIDED BY THE TREATING PHYSICIAN AND IS SUMMARIZED HERE FOLLOWED BY MICROVENTION¿S ANALYSIS. THE RECORDS REFLECT THAT THE PATIENT PRESENTED WITH AN ACUTE SAH, AND WAS IN A BAD CLINICAL GRADE (WFNS 4 OUT OF 5). THE PATIENT HAD MULTIPLE ANEURYSMS (4) BUT, BASED ON THE BLOOD PATTERN ON CT AND THE SIZE OF THE ANEURYSM, IT WAS BELIEVED BY THE CLINICAL TEAM TREATING THE PATIENT THAT THE APPROXIMATELY 8 MM SACCULAR BASILAR TIP ANEURYSM WAS THE SOURCE OF THE SAH. THE OTHER ANEURYSMS WERE: TWO DISTAL RIGHT MCA AND ONE DISTAL LEFT MCA, WHICH WERE BOTH SMALL AND HAD AN UNUSUAL APPEARANCE, REMINISCENT OF MYCOTIC ANEURYSMS. ACCORDING TO THE RECORDS PROVIDED, THE MEDICAL TEAM DECIDED TO TREAT THE BASILAR TIP ANEURYSM WITH A WEB AND TREAT THE OTHER ANEURYSMS WITH COILS AT A SUBSEQUENT TIME. THE IMAGES OF THE TREATMENT PROVIDED TO MICROVENTION SHOW THAT THE FIRST WEB THAT WAS CHOSEN WAS TOO LARGE AND OCCLUDED BOTH P1 SEGMENTS. THIS CONCLUSION WAS ALSO REFLECTED IN THE TREATING PHYSICIAN¿S REPORT TO MICROVENTION. AS HE INDICATED AND WAS REPORTED IN THE ORIGINAL MDR, THAT FIRST WEB WAS REPLACED BY A SMALLER WEB, WHICH FITTED BETTER AND, AFTER SOME REPOSITIONING, RESPECTED BOTH P1S. THE FINAL POST-TREATMENT ANGIO SHOWED GOOD APPOSITION OF THE EDGES OF THE WEB TO THE NECK OF THE ANEURYSM. ON DAY 9 FROM SAH, THE RECORDS INDICATE THAT THE PATIENT WAS IN A PERSISTENT VEGETATIVE STATE DUE TO EXTENSIVE BILATERAL MCA CEREBRAL INFARCTION (DOCUMENTED BY MRI) FROM SEVERE POST-SAH VASOSPASM. THE SEVERE VASOSPASM OF BOTH ICA AND POSTERIOR CIRCULATION MAJOR VESSELS WAS DEMONSTRATED BY CEREBRAL ANGIOGRAPHY ON DAY 9. PTA AND ARTERIAL INJECTION OF ERIL WAS PERFORMED FOR VASOSPASM. THE POSTERIOR CIRCULATION ANGIOGRAM DEMONSTRATED EXTENSIVE REGROWTH AT THE BASE OF THE ANEURYSM ¿ THE REGROWTH WAS AS LARGE AS THE ORIGINAL ANEURYSM. ACCORDING TO THE IMAGES AND HISTORY PROVIDED, IT SEEMS THAT THE REGROWTH WAS NOT RETREATED. IT WAS REPORTED IN THE RECORDS THAT ON DAY 16 FROM SAH, THE PATIENT SUFFERED ANOTHER SAH. BASED ON THE CT BLOOD PATTERN, THE BASILAR TIP ANEURYSM REGROWTH WAS THE SOURCE OF THE SAH. THE PATIENT ALSO HAD SEVERE HYDROCEPHALUS. BASED ON THE PATIENT¿S CLINICAL STATUS AND THE FAMILY¿S WISHES, SUPPORTIVE TREATMENT ONLY WAS OFFERED, AND THE PATIENT EXPIRED ON DAY 24 POST-SAH. CEREBRAL ANEURYSMS ARE NOT COMMON IN PATIENTS OF THIS AGE. IN ADDITION, 3 OF THE 4 ANEURYSMS WERE EXTREMELY ATYPICAL, BEING LOCATED IN THE DISTAL MCAS. THE LOCATION AND APPEARANCE OF THESE MCA ANEURYSMS STRONGLY SUGGEST THE POSSIBILITY THAT THEY MAY BE MYCOTIC OR VASCULITIC/VASCULOPATHIC IN NATURE. IF THAT IS ALSO THE CASE FOR THE BASILAR TIP ANEURYSM, IT IS NOT SURPRISING THAT A LARGE RECURRENCE OCCURRED OVER THE SHORT TIME DESCRIBED IN THE REPORT. BASED ON THE CASE PRESENTATION REVIEW, IT IS THE MEDICAL OPINION THAT THE WEB FUNCTIONED AS INTENDED AND WAS NOT CAUSALLY RELATED TO THE PATIENT¿S OUTCOME.

    Description of Event or Problem · 0

    MICROVENTION WAS INFORMED OF A PATIENT DEATH 24 DAYS AFTER A MEDICAL PROCEDURE TO TREAT SUBARACHNOID HEMORRHAGE INCLUDING THE USE OF ONE OF MICROVENTION'S PRODUCTS. MICROVENTION LEARNED FROM THE MEDICAL PROVIDER THAT ON (B)(6) 2023, THE PATIENT WAS DIAGNOSED WITH SUBARACHNOID HEMORRHAGE (SPECIFICALLY HUNT & HESS GRADE 4, WFNS GRADE 4, FISHER GROUP 3). ON (B)(6) 2023, IT WAS REPORTED THAT TREATMENT INCLUDING THE USE OF MICROVENTION'S W-EB WAS PERFORMED. THE PHYSICIAN ATTEMPTED TO ADDRESS A RUPTURED ANEURYSM IN THE TIP OF THE BASILAR ARTERY USING A W-EB (SL5X4), AND AFTER DEPLOYMENT IT WAS FOUND TO BE OVERSIZED AND WAS REMOVED. A W-EB (SL5×3) WAS IMPLANTED. THE PHYSICIAN INDICATED HE WAS AWARE THAT THE W-EB HE SELECTED WAS A LITTLE UNDERSIZED, BUT NO ISSUES WERE NOTED WITH ANGIOGRAPHY, AND HE INDICATED THAT P1 PRESERVATION WAS PRIORITIZED BY THE PREOPERATIVE STRATEGY. THE PHYSICIAN DETERMINED THAT THERE WERE NO PROBLEMS, AND THE PROCEDURE WAS COMPLETED. PER THE PHYSICIAN'S NOTES, ON THE 8TH DAY AFTER THE PROCEDURE, A SHORTENING OF THE W-EB WAS IDENTIFIED DURING SPASM TREATMENT. ON THE 16TH DAY AFTER THE PROCEDURE, THE REPORT INDICATED THAT RE-BLEEDING OCCURRED. ON THE 24TH DAY AFTER THE PROCEDURE, THE PATIENT DIED. NO INDICATIONS OF DEVICE MALFUNCTION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1487560 WEB SL INTRASACCULAR DEVICES OPR MICROVENTION, INC. MV-WB050321 0000130626 04987892122309

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Female Death