BEUDAMED
    FDA Adverse Event Injury Summary report: N

    132CM LARGE BORE 71 CATHETER

    MDR report key: 19724408 · Received July 11, 2024

    Report

    Report Number
    3008114965-2024-00694
    Event Type
    Injury
    Date Received
    July 11, 2024
    Date of Event
    June 18, 2024
    Report Date
    July 24, 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). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, RACE, AND ETHNICITY WAS NOT REPORTED. SECTION A1. PATIENT IDENTIFIER: (B)(6). SECTION D2B: PROCODE IS 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. HEMORRHAGE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ENDOVASCULAR MECHANICAL THROMBECTOMY FOR ACUTE ISCHEMIC STROKE CASES AND IS LISTED IN THE EMBOVAC INSTRUCTIONS FOR USE (IFU) AS SUCH. THERE WERE NO ALLEGED QUALITY ISSUES RELATED TO THE USED DEVICE, AS THE DEVICE PERFORMED AS INTENDED. THE INVESTIGATOR FELT THE EVENT OF ¿SMALL FOCUS OF SUBARACHNOID HEMORRHAGE¿ WAS POSSIBLY RELATED EMBOVAC DEVICE AND POSSIBLY RELATED TO THE PRIMARY PROCEDURE; THEREFORE, THE CORRELATING RELATIONSHIP BETWEEN THE EVENT TO THE USED DEVICE AS A CONTRIBUTING FACTOR CANNOT BE RULED OUT ENTIRELY. ADDITIONALLY, THE SEVERITY OF THE EVENT IS UNKNOWN, AS THE PATIENT¿S 7-DAY POST-PROCEDURE ASSESSMENTS WERE NOT MADE AVAILABLE AT THE TIME OF THIS REVIEW. BASED ON THIS INFORMATION AND THE ASSESSMENT OF THE PI, THIS EVENT DOES MEET US FDA REPORTING CRITERIA UNDER 21 CFR 803 WITH A 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. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). SECTION B5: ADDITIONAL/MODIFIED INFORMATION WAS RECEIVED ON 19-JUL-2024. SUMMARY: REGARDING THE ADVERSE EVENT OF ¿SMALL FOCUS OF SUBARACHNOID HEMORRHAGE,¿ THE OUTCOME OF "RECOVERING/RESOLVING" WAS UPDATED TO "NOT RECOVERED/NOT RESOLVED." 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). UPDATED SECTIONS ON THIS MED WATCH: CONCOMITANT PRODUCTS. ADDITIONAL INFORMATION WAS NOTED ON THE EXCELLENT CLINICAL STUDY DATABASE, CRF, AT THE TIME OF THIS REVIEW, 11-JUL-2024. SUMMARY: ON 16-JUN-2024, THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY USING AN EMBOVAC 132CM LARGE BORE 71 CATHETER (IC71132UG/ 31247203) FOR OCCLUSIONS AT THE RIGHT INTERNAL CAROTID ARTERY (ICA) AND 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 AT THE MCA SITE, WHICH RESULTED IN A MTICI SCORE OF 2B, WITH NO CLOT RETRIEVAL. THE 2ND PASS WAS MADE USING A TREVO STENT-RETRIEVER AT THE ICA SITE, WHICH RESULTED IN A MTICI SCORE OF 3, WITH NO CLOT RETRIEVAL. DURING THE PROCEDURE, A GUIDEWIRE WAS USED, BUT THE BRAND WAS NOT SPECIFIED. A 0.088 BALLAST LONG SHEATH WAS ALSO USED. NO FURTHER INFORMATION WAS MADE AVAILABLE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 0

    AS REPORTED VIA THE EXCELLENT STUDY (B)(6), A 57-YEAR-OLD FEMALE (B)(6) WITH A MEDICAL HISTORY OF DIABETES AND HYPERTENSION, PRESENTED WITH AN UNWITNESSED NON-WAKE UP STROKE. LAST TIME SEEN WELL WAS ON 16-JUN-2024 AT 15:20. SYMPTOMS WERE FIRST OBSERVED ON 16-JUN-2024 AT 16:50. THE PATIENT WAS PRESENTED TO THE TREATING HOSPITAL ON (B)(6) 2024 AT 16:50. 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 22 AND A MRS SCORE OF ¿0-NO SYMPTOMS.¿ ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY USING AN 132CM LARGE BORE 71 CATHETER (IC71132UG, 31247203). DETAILS OF THIS PROCEDURE WERE NOT MADE AVAILABLE AT THE TIME OF THIS REVIEW. THERE WERE NO INTRAOPERATIVE STUDY DEVICE DEFICIENCIES. THE PATIENT¿S 24-HOUR POST-PROCEDURE NIHSS SCORE WAS 16. ON 18-JUN-2024, THE PATIENT EXPERIENCED THE ADVERSE EVENT OF ¿SMALL FOCUS OF SUBARACHNOID HEMORRHAGE,¿ WHICH BECAME KNOWN TO THE SITE AND SPONSOR ON 21-JUN-2024. THE PRINCIPAL INVESTIGATOR (PI) ASSESSED THIS EVENT AS NOT SERIOUS, MILD IN SEVERITY, AND AS NOT RELATED TO THE EMBOTRAP DEVICE, POSSIBLY RELATED TO THE LARGE BORE CATHETER, NOT RELATED TO THE CEREGLIDE 71, AND POSSIBLY RELATED TO THE PRIMARY 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
    2385215 132CM LARGE BORE 71 CATHETER CATHETER, ASPIRATION CATHETER NRY MEDOS INTERNATIONAL SARL 31247203 10886704082378

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Life Threatening 0.088 BALLAST LONG SHEATH| UNSPECIFIED GUIDEWIRE