BEUDAMED
    FDA Adverse Event Injury Summary report: N

    132CM LARGE BORE 71 CATHETER

    MDR report key: 19784139 · Received July 19, 2024

    Report

    Report Number
    3008114965-2024-00710
    Event Type
    Injury
    Date Received
    July 19, 2024
    Date of Event
    June 30, 2024
    Report Date
    August 13, 2024
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NRY
    UDI-DI
    10886704082378
    PMA / PMN Number
    K191237
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). SECTION B5: ADDITIONAL INFORMATION WAS RECEIVED ON 11-AUG-2024. SUMMARY: THE FINAL/ END OF PROCEDURE MTICI SCORE WAS CONFIRMED TO BE ¿2B.¿ REGARDING THE ADVERSE EVENT OF ¿SUBARACHNOID HEMORRHAGE AT THE RIGHT SYLVIAN FISSURE AND RIGHT TEMPORAL LOBE SULCI,¿ THE EVENT WAS ASSOCIATED VESSEL TRAUMA; ¿LIKELY FROM THE MULTIPLE STENT RETRIEVER PASSES.¿ REGARDING THE PHYSICIAN'S OPINION ON FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT, IT WAS SAID, ¿STRAIGHTENING OF THE M1/M2 WITH STENT RETRIEVER PULLS.¿ A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). SECTION B5: ADDITIONAL/MODIFIED INFORMATION WAS RECEIVED ON 19-JUL-2024. SUMMARY: REGARDING THE EVENT OF ¿SUBARACHNOID HEMORRHAGE AT THE RIGHT SYLVIAN FISSURE AND RIGHT TEMPORAL LOBE SULCI,¿ THE OUTCOME OF "RECOVERING/RESOLVING" WAS UPDATED TO "NOT RECOVERED/NOT RESOLVED." ADDITIONAL INFORMATION WAS NOTED ON THE CLINICAL DATABASE AT THE TIME OF THIS REVIEW, 24-JUL-2024. SUMMARY: ON 19-JUL-2024, THE PATIENT WAS DISCHARGED HOME FOR SELF-CARE, WITH AN NIHSS SCORE OF 5 AND A MRS SCORE OF ¿2-SLIGHT DISABILITY; UNABLE TO CARRY OUT ALL PREVIOUS ACTIVITIES, BUT ABLE TO LOOK AFTER OWN AFFAIRS WITHOUT ASSISTANCE.¿ A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). SECTION A1. PATIENT IDENTIFIER: (B)(6). SECTION D2B ¿ PROCODE: NRY/QJP. THE DEVICE WAS DISCARDED; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31247203 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE MALFUNCTION WERE IDENTIFIED. SUBARACHNOID HEMORRHAGE IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE USE OF THE EMBOVAC LARGE BORE CATHETER AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. THERE WERE NO ALLEGED QUALITY ISSUES RELATED TO THE USED DEVICE, AS THE DEVICE PERFORMED AS INTENDED. THERE MAY HAVE BEEN CLINICAL AND PROCEDURAL FACTORS, INCLUDING VESSEL CHARACTERISTICS, DEVICE INTERACTION, AND OPERATOR TECHNIQUE, THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT, RATHER THAN THE DESIGN OR MANUFACTURE OF THE DEVICE. HOWEVER, SINCE THE PI ASSESSED THE EVENT AS POSSIBLY RELATED TO THE EMBOVAC DEVICE AND POSSIBLY RELATED TO THE PROCEDURE, THE CORRELATING RELATIONSHIP BETWEEN EVENT TO USED DEVICE AS A CONTRIBUTING FACTOR CANNOT BE RULED OUT COMPLETELY. ADDITIONALLY, THE SEVERITY OF THE EVENT/IMPACT TO THE PATIENT IS UNKNOWN, AS THE PATIENT¿S SEVEN-DAY POST-OPERATIVE ASSESSMENT SCORES WERE NOT MADE AVAILABLE AT THE TIME OF THIS REVIEW. BASED ON THIS INFORMATION AND THE ASSESSMENT OF THE PI, THE EVENT OF ¿SUBARACHNOID HEMORRHAGE AT THE RIGHT SYLVIAN FISSURE AND RIGHT TEMPORAL LOBE SULCI¿ DOES MEET US FDA REPORTING CRITERIA UNDER 21 CFR 803 WITH THE CLASSIFICATION OF ¿SERIOUS INJURY.¿ THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY CERENOVUS, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, CERENOVUS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    AS REPORTED VIA THE EXCELLENT STUDY (B)(6), A 61-YEAR-OLD MALE (SUBJECT (B)(6) WITH A MEDICAL HISTORY OF HYPERTENSION, PRESENTED WITH AN UNWITNESSED NON-WAKE UP STROKE. LAST TIME SEEN WELL WAS ON (B)(6) 2024 AT 09:00. SYMPTOMS WERE FIRST OBSERVED ON (B)(6)2024 AT 09:30. THE PATIENT WAS PRESENTED TO THE TREATING HOSPITAL ON THE SAME DAY AT 19:17, WHERE CT IMAGING CONFIRMED AN ISCHEMIC STROKE. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT ADMINISTERED AT THE TIME OF STROKE PRESENTATION. THE SUSPECTED ORIGIN OF THE EMBOLISM WAS ¿UNDETERMINED ETIOLOGIES.¿ THE PATIENT¿S BASELINE NIHSS SCORE WAS 12 AND MODIFIED RANKIN SCALE SCORE MRS SCORE WAS ¿1-NO SIGNIFICANT DISABILITY. ABLE TO CARRY OUT ALL USUAL DUTIES AND ACTIVITIES.¿ ON (B)(6)2024, THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY USING AN EMBOVAC IC 71, 132 CM, CE, ASP. IND. LARGE BORE CATHETER (IC71132UG/ 31247203) FOR AN OCCLUSION AT THE M1 SEGMENT OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). THE PRE-PASS MTICI SCORE WAS 0. THE 1ST PASS WAS MADE USING THE DIRECT CONTACT ASPIRATION DEVICE ALONE, WHICH RESULTED IN A MTICI SCORE OF 2B, WITH NO CLOT RETRIEVAL. DURING THE PROCEDURE, A GUIDEWIRE WAS USED, BUT THE BRAND WAS NOT SPECIFIED. A 0.021 TREVO MICROCATHETER AND AN 8 BALLAST LONG SHEATH WERE ALSO USED. THERE WERE NO STUDY DEVICE DEFICIENCIES DURING THE PROCEDURE. THE PATIENT¿S 24-HOUR POST-PROCEDURE NIHSS SCORE WAS 8. ON (B)(6)2024, THE PATIENT EXPERIENCED THE EVENT OF ¿SUBARACHNOID HEMORRHAGE AT THE RIGHT SYLVIAN FISSURE AND RIGHT TEMPORAL LOBE SULCI,¿ WHICH WAS MADE KNOWN TO THE SITE AND SPONSOR ON (B)(6)2024. THE PRINCIPAL INVESTIGATOR (PI) ASSESSED THIS EVENT AS NOT SERIOUS, MILD IN SEVERITY, AND AS UNRELATED TO THE EMBOTRAP III STUDY DEVICE, POSSIBLY RELATED TO THE LARGE BORE CATHETER, UNRELATED TO THE CEREGLIDE71 INTERMEDIATE CATHETER, AND POSSIBLY RELATED TO THE PRIMARY SURGICAL PROCEDURE. THE EVENT WAS NOT MEDICALLY TREATED. THE OUTCOME IS RECORDED AS ¿RECOVERING/RESOLVING¿ WITH NO END DATE LISTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1917999 132CM LARGE BORE 71 CATHETER CATHETER, ASPIRATION CATHETER NRY MEDOS INTERNATIONAL SARL 31247203 10886704082378

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Life Threatening .021 TREVO MICROCATHETER| 8 BALLAST LONG SHEATH| UNSPECIFIED GUIDEWIRE