BEUDAMED
    FDA Adverse Event Injury Summary report: N

    132CM LARGE BORE 71 CATHETER

    MDR report key: 18374786 · Received December 21, 2023

    Report

    Report Number
    3008114965-2023-00968
    Event Type
    Injury
    Date Received
    December 21, 2023
    Date of Event
    October 24, 2023
    Report Date
    January 10, 2024
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NRY
    UDI-DI
    10886704082378
    PMA / PMN Number
    K191237
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR IS TO INCLUDE THE ADDITIONAL EVENT INFORMATION RECEIVED ON 09-JAN-2024, THAT CHANGED THE REPORTABILITY OF THE EVENT AS RELATED TO THIS PRODUCT REPORTED IN THIS MEDWATCH REPORT. [ADDITIONAL]: ON 09-JAN-2024, ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL FROM THE EXCELLENT CLINICAL STUDY TEAM. THE PRINCIPAL INVESTIGATOR (PI) PROVIDED THE RESPONSES BELOW FOR SUBJECT 915-144: ¿ALTHOUGH THE LAST CT HEAD REPORTED IT AS SAH (SUBARACHNOID HEMORRHAGE), I DISAGREE. THE MRI BRAIN IN THE SAME AREA REPORTS: CORTICAL HEMOSIDERIN STAINING VERSUS PETECHIAL MICROHEMORRHAGE ALONG THE HIGH RIGHT PARIETAL CONVEXITY.¿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¿SMALL VOLUME ACUTE SUBARACHNOID BLOOD PRODUCTS ALONG THE RIGHT PARIETAL CONVEXITY¿ WAS CONFIRMED TO HAVE OCCURRED AT A LOCATION THAT WAS NOT RELEVANT TO WHERE THE DEVICES WERE USED. THEREFORE, THE CORRELATING RELATIONSHIP BETWEEN EVENT AND USED DEVICE CAN BE RULED OUT COMPLETELY. THE EVENT OF A SUBARACHNOID HEMORRHAGE NO LONGER MEETS USFDA MEDICAL DEVICE REPORTING CRITERIA.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT DATE OF BIRTH WAS NOT PROVIDED. BASED ON COMPLAINT INFORMATION, THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (30908801) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. PRODUCT ANALYSIS CANNOT BE CONDUCTED AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO DETERMINATION OF CAUSES AND POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. THERE WAS NO DEVICE PERFORMANCE ISSUE OR DEVICE MALFUNCTION REPORTED DURING THE PROCEDURE. BASED ON THE MANUFACTURING DOCUMENTATION REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. THERE IS NO MEDICAL EVIDENCE TO SUGGEST THE EVENT OF AN ARTERIAL RE-OCCLUSION WOULD BE RELATED TO THE STUDY DEVICE. THERE WERE NO ALLEGED QUALITY ISSUES/MALFUNCTIONS RELATED TO THE USED DEVICE, AS THE DEVICE PERFORMED AS INTENDED. THE PI ASSESSED THE SECOND THROMBECTOMY DUE TO RE-OCCLUSION AS UNRELATED TO THE STUDY DEVICE AND UNRELATED TO THE STUDY PROCEDURE. BASED ON THE LIMITED INFORMATION AVAILABLE AND THE ASSESSMENT OF THE PI, THE EVENT OF ARTERIAL OCCLUSION DOES NOT MEET US FDA REPORTING CRITERIA 21 CFR 803. PER THE ADDITIONAL INFORMATION RECEIVED ON 01-DEC-2023, THE PATIENT EXPERIENCED THE EVENT OF ¿SMALL VOLUME ACUTE SUBARACHNOID BLOOD PRODUCTS ALONG THE RIGHT PARIETAL CONVEXITY.¿ PI ASSESSED THE EVENT AS NOT SERIOUS, MILD IN SEVERITY, AND AS UNRELATED TO THE STUDY DEVICE, UNRELATED TO THE LARGE BORE CATHETER, AND UNRELATED TO THE PRIMARY PROCEDURE. BASED ON THE NEW INFORMATION WHICH PROVIDES THE PROCEDURE DATE ((B)(6) 2023), THE SUBARACHNOID HEMORRHAGE OCCURRED FOUR DAYS AFTER THE PROCEDURE. IT IS POSSIBLE VESSEL INJURY OCCURRED DURING THE PROCEDURE, AND ¿SMALL VOLUME ACUTE SUBARACHNOID BLOOD PRODUCTS¿ WAS FOUND FOUR (4) DAYS LATER. CURRENTLY, THE CORRELATION BETWEEN USED DEVICE TO THE EVENT OF A SUBARACHNOID HEMORRHAGE CANNOT BE RULED OUT COMPLETELY. THEREFORE, THIS EVENT WILL BE CONSERVATIVELY REPORTED TO THE US FDA REPORTING UNDER CRITERIA 21 CFR 803 WITH A CLASSIFICATION OF A ¿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 FOR STATISTICAL SIGNALS AND CORRECTIVE / PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. 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. THIS IS ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 3011370111-2023-00204 AND 3008114965-2023-00968. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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. 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 MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    THE EVENT WAS REPORTED VIA THE EXCELLENT STUDY, THE 69-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF ATRIAL FIBRILLATION, CORONARY ARTERY DISEASE (CAD), CONGESTIVE HEART FAILURE, AND A HISTORY OF HEMORRHAGE STROKE PRESENTED WITH AN UNWITNESSED NON-WAKE UP STROKE. THE LAST TIME SHE WAS SEEN WELL WAS ON (B)(6) 2023. SYMPTOMS WERE FIRST OBSERVED ON (B)(6) 2023 AT 05:30 HOUR. THE PATIENT PRESENTED TO THE TREATING HOSPITAL ON (B)(6) 2023 AT 06:43 HOUR. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT ADMINISTERED AT THE TIME OF STROKE PRESENTATION. THE SUSPECTED ORIGIN OF THE EMBOLISM WAS NOT ADMINISTERED AT THE TIME OF STROKE PRESENTATION. THE SUSPECTED ORIGIN OF THE EMBOLISM IS DOCUMENTED AS UNDETERMINED ETIOLOGIES. THE PATIENT¿S BASELINE NIH STROKE SCALE (NIHSS) SCORE WAS 13 AND A MODIFIED RANKIN SCALE (MRS) SCORE OF 2 ¿ ¿SLIGHT DISABILITY; ; UNABLE TO CARRY OUT ALL PREVIOUS ACTIVITIES, BUT ABLE TO LOOK AFTER OWN AFFAIRS WITHOUT ASSISTANCE.¿ THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY ON AN UNKNOWN DATE USING AN UNKNOWN EMBOTRAP REVASCULARIZATION DEVICE (CATALOG / LOT NUMBER# UNKNOWN). PROCEDURE DETAILS HAVE NOT BEEN DOCUMENTED IN THE CASE REPORT FORM (CRF) AT THE TIME OF THE COMPLAINT REVIEW. THE PATIENT¿S 24-HOUR POST-PROCEDURE NIHSS SCORE WAS 5. ON (B)(6) 2023, THE PATIENT EXPERIENCED A REOCCLUSION OF INITIAL VESSEL. THE PRINCIPAL INVESTIGATOR (PI) ASSESSED THE EVENT AS A SERIOUS AND SEVERE ADVERSE EVENT THAT COULD RESULT IN SERIOUS DETERIORATION OF HEALTH, AND WAS UNRELATED TO THE STUDY DEVICE, UNRELATED TO THE LARGE BORE CATHETER, AND UNRELATED TO THE SURGICAL PROCEDURE. THE EVENT REQUIRED THE SURGICAL INTERVENTION OF A THROMBECTOMY. THE OUTCOME IS RECORDED AS ¿RECOVERING/RESOLVING.¿ ON (B)(6) 2023, THE PATIENT EXPERIENCED A RIGHT GROIN BLEED. THE PI ASSESSED THE EVENT AS NOT SERIOUS, MILD IN SEVERITY BUT COULD RESULT IN SERIOUS DETERIORATION OF HEALTH, AND WAS UNRELATED TO THE STUDY DEVICE, UNRELATED TO THE LARGE BORE CATHETER, BUT PROBABLY RELATED TO THE SURGICAL PROCEDURE. IT WAS COMMENTED THAT THE ¿PT [PATIENT] REPORTED TO HAVE OOZING FROM RIGHT GROIN FROM PUNCTURE SITE. PRESSURE DRESSING APPLIED¿. THE EVENT REQUIRED THE APPLICATION OF A PRESSURE DRESSING. THE OUTCOME IS RECORDED AS ¿RECOVERING/RESOLVING.¿ SINCE ¿OOZING FROM THE PUNCTURE SITE¿ WOULD BE RELATED TO THE SHEATH OR METHOD OF HEMOSTASIS USED, AND THE PRINCIPAL INVESTIGATOR ASSESSED THE EVENT AS UNRELATED TO THE STUDY DEVICE, THE EVENT OF ¿RIGHT GROIN BLEED¿ WILL BE CONSIDERED A NON-PRODUCT ISSUE (NPI) AND WILL BE NEITHER CODED NOR REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 01-DEC-2023. THE INFORMATION INDICATED THAT THE PATIENT EXPERIENCED A SMALL VOLUME ACUTE SUBARACHNOID BLOOD PRODUCTS ALONG THE RIGHT PARIETAL CONVEXITY. THE PI ASSESSED THE EVENT AS NOT SERIOUS, MILD IN SEVERITY, AND AS UNRELATED TO THE STUDY DEVICE, UNRELATED TO THE LARGE BORE CATHETER, AND UNRELATED TO THE PRIMARY PROCEDURE. THE EVENT WAS NOT MEDICALLY TREATED, AND THE OUTCOME IS RECORDED AS ¿NOT RECOVERED/ NOT RESOLVED.¿ ON 13-DEC-2023, MODIFIED INFORMATION WAS RECEIVED. PER THE MODIFIED INFORMATION, THE ADVERSE EVENT TERM: "REOCCLUSION OF INITIAL VESSEL" WAS UPDATED TO "NEW OCCLUSION AT R M2." ¿IF EVENT IS BOTH SERIOUS AND DEVICE OR PROCEDURE RELATED, IN THE OPINION OF THE INVESTIGATOR AND IN ACCORDANCE WITH THE LIST OF EXPECTED EVENTS IN THE PROTOCOL AND INSTRUCTIONS FOR USE, IS THE ADVERSE EVENT:¿ WAS UPDATED FROM "BLANK" TO "EXPECTED/ANTICIPATED." REGARDING THE ADVERSE EVENT OF ¿RIGHT GROIN BLEED,¿ THE FOLLOWING FIELD WAS UPDATED: UPDATED: ¿IF EVENT IS BOTH SERIOUS AND DEVICE OR PROCEDURE RELATED, IN THE OPINION OF THE INVESTIGATOR AND IN ACCORDANCE WITH THE LIST OF EXPECTED EVENTS IN THE PROTOCOL AND INSTRUCTIONS FOR USE, IS THE ADVERSE EVENT:¿ WAS UPDATED FROM "BLANK" TO "N/A (DOES NOT MEET ABOVE CRITERIA)." ON (B)(6) 2023, THE EXCELLENT CLINICAL STUDY TEAM STATED THAT A LARGE BORE CATHETER (LBC) WAS ALSO USED ON THE FIRST PASS WITH THE EMBOTRAP DEVICE. THE CATALOG AND LOT NUMBER OF THE LBC WAS NOT KNOWN. ON 19-DEC-2023, PER THE INFORMATION, A 6.5MM X 45MM EMBOTRAP III REVASCULARIZATION (ET309645 / 23D143AV) WAS USED. THE LARGE BORE CATHETER (LBC) USED IN THE FIRST PASS WITH THE EMBOTRAP III IS A 132CM LARGE BORE 71 CATHETER (IC71132UG / 30908801). BASED ON THE ADDITIONAL INFORMATION RECEIVED ON 01-DEC-2023, THE PATIENT EXPERIENCED THE ADVERSE EVENT FOUR DAYS AFTER THE PROCEDURE. IT IS POSSIBLE VESSEL INJURY OCCURRED DURING THE PROCEDURE, AND THE REPORTED ¿SMALL VOLUME ACUTE SUBARACHNOID BLOOD PRODUCTS¿ WAS FOUND FOUR (4) DAYS LATER. CURRENTLY, THE CORRELATION BETWEEN USED DEVICE TO THE EVENT OF A SUBARACHNOID HEMORRHAGE CANNOT BE RULED OUT COMPLETELY. THEREFORE, THIS EVENT WILL BE CONSERVATIVELY REPORTED TO THE US FDA REPORTING UNDER CRITERIA 21 CFR 803 WITH A CLASSIFICATION OF A ¿SERIOUS INJURY.¿ BASED ON THE ADDITIONAL INFORMATION RECEIVED ON 06-DEC-2023 AND 19-DEC-2023, THE LBC DEVICE MEETS US FDA REPORTING UNDER CRITERIA 21 CFR 803 WITH A CLASSIFICATION OF A ¿SERIOUS INJURY¿ AS IT WAS USED WITH THE EMBOTRAP III DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2051044 132CM LARGE BORE 71 CATHETER CATHETER, ASPIRATION CATHETER NRY MEDOS INTERNATIONAL SARL 30908801 10886704082378

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Life Threatening EMBOTRAP III 6.5 MM X 45 MM