132CM LARGE BORE 71 CATHETER
Report
- Report Number
- 3008114965-2024-00657
- Event Type
- Injury
- Date Received
- July 16, 2024
- Date of Event
- June 27, 2024
- Report Date
- August 21, 2025
- Manufacturer
- MEDOS INTERNATIONAL SARL
- Product Code
- NRY
- UDI-DI
- 10886704082378
- PMA / PMN Number
- K191237
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT DATE OF BIRTH WAS NOT PROVIDED. SECTION D.2B: PROCODE IS NRY/QJP. SECTION E.1: THE INITIAL REPORTER PHONE IS NOT AVAILABLE / REPORTED. BASED ON COMPLAINT INFORMATION, THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (31202405) 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. 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 ¿TRACE PETECHIAL HEMORRHAGE IN THE FRONTAL OPERCULUM¿ 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 THE LIMITED INFORMATION AVAILABLE AND THE ASSESSMENT OF THE PI, THIS EVENT MEETS 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 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 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.
MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO INCLUDE THE ADDITIONAL INFORMATION RECEIVED ON 11-AUG-2024. [ADDITIONAL INFORMATION]: ON 11-AUG-2024, ADDITIONAL INFORMATION WAS RECEIVED FROM THE EXCELLENT CLINICAL STUDY TEAM. PER THE INFORMATION, THE SITE OF THE PETECHIAL HEMORRHAGE WAS DISTAL TO WHERE THE OCCLUSION WAS. PER THE PRINCIPAL INVESTIGATOR, REGARDING WHETHER THERE WAS ANY VESSEL INJURY / TRAUMA THAT MAY HAVE LED TO THE REPORTED ADVERSE EVENT: ¿NOT IN MY OPINION, A ZOOM 45 WAS TAKEN DISTALLY AND ASPIRATION WAS PERFORMED. COULD ALSO BE FROM REPERFUSION SINCE TANDEM OCCLUSION.¿ IT WAS CONFIRMED THERE WAS NO DEVICE DEFICIENCIES RELATED TO THE STUDY DEVICE DURING THE PROCEDURE. THE ADDITIONAL INFORMATION RECEIVED ON 11-AUG-2024 WAS THOROUGHLY DISCUSSED WITH THE MEDICAL SAFETY OFFICER (MSO) ON 13-AUG-2024. PER THE MSO, THE INVESTIGATOR FELT THE EVENT COULD BE CAUSED BY A REPERFUSION INJURY BUT COULD ALSO BE POSSIBLY RELATED TO THE EMBOVAC DEVICE. BASED ON THE PI¿S ASSESSMENT OF THE EVENT BEING POSSIBLY RELATED TO THE EMBOVAC DEVICE, THE EVENT WILL BE CONSERVATIVELY REPORTED TO THE USFDA. ADDITIONALLY, THE HEMORRHAGE OCCURRING AT A DISTAL LOCATION TO THE TARGET LESION DOES NOT RULE OUT DEVICE INVOLVEMENT. PER THE ADDITIONAL INFORMATION RECEIVED ON 11-AUG-2024, THE INVESTIGATOR FELT THE EVENT COULD HAVE BEEN CAUSED BY A REPERFUSION INJURY OR COULD ALSO BE POSSIBLY RELATED TO THE USE OF THE EMBOVAC DEVICE. BASED ON THE PI¿S ASSESSMENT OF THE EVENT BEING POSSIBLY RELATED TO THE EMBOVAC DEVICE, THE EVENT WILL BE CONSERVATIVELY REPORTED TO THE USFDA. ADDITIONALLY, THE HEMORRHAGE OCCURRING AT A DISTAL LOCATION TO THE TARGET LESION DOES NOT RULE OUT DEVICE INVOLVEMENT. BASED ON THE ASSESSMENTS OF THE PI AND MSO, NO CHANGES REGARDING THE REPORTABILITY DETERMINATION NOR CODING WERE REQUIRED. THE EVENT OF ¿TRACE PETECHIAL HEMORRHAGE IN THE FRONTAL OPERCULUM¿ REMAINS REPORTABLE TO THE USFDA. THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. REFERENCES: HONG JM, KIM DS, KIM M. HEMORRHAGIC TRANSFORMATION AFTER ISCHEMIC STROKE: MECHANISMS AND MANAGEMENT. FRONT NEUROL. 2021 NOV 30;12:703258. DOI: 10.3389/FNEUR.2021.703258. PMID: 34917010; PMCID: PMC8669478. TATJANA RUNDEK, RALPH L. SACCO. 16 - PROGNOSIS AFTER STROKE, STROKE (SIXTH EDITION), ELSEVIER, 2016, PP. 234-252.E10, ISBN 9780323295444. HTTPS://DOI.ORG/10.1016/B978-0-323-29544-4.00016-5. 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.
MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO INCLUDE THE MODIFIED INFORMATION RECEIVED ON 17-JUL-2024. [MODIFIED INFORMATION]: ON 17-JUL-2024, MODIFIED INFORMATION WAS RECEIVED, RELATED TO THE OUTCOME AND END DATE OF THE ADVERSE EVENT, ¿TRACE PETECHIAL HEMORRHAGE IN THE FRONTAL OPERCULUM'. THE OUTCOME OF THE ADVERSE EVENT, ¿TRACE PETECHIAL HEMORRHAGE IN THE FRONTAL OPERCULUM' HAS BEEN UPDATED FROM "RECOVERING/RESOLVING" TO "RECOVERED/RESOLVED". THE END DATE OF THIS EVENT WAS UPDATED, FROM BLANK TO (B)(6) 2024. 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.
MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO INCLUDE THE SOURCE OF THE ADDITIONAL INFORMATION RECEIVED ON 22-JUL-2025. [ADDITIONAL INFORMATION]: ON 22-JUL-2025, ADDITIONAL / MODIFIED INFORMATION WAS RECEIVED. A CLINICAL EVENT COMMITTEE (CEC) ADJUDICATION FOR THE ADVERSE EVENT ¿PROGRESSION OF INDEX STROKE¿ WAS RECEIVED. THE CEC ADJUDICATED EVENT TERM WAS UPDATED FROM ¿PROGRESSION OF INDEX STROKE¿ TO ¿LEFT ICA REOCCLUSION.¿ THE RELATIONSHIP OF EVENT TO THE PRIMARY STUDY PROCEDURE WAS UPDATED FROM ¿NOT RELATED¿ TO ¿POSSIBLE.¿ THE EVENT WAS REPORTED AS LIFE-THREATENING AND RESULTED IN PERMANENT IMPAIRMENT. IT WAS FURTHER COMMENTED THAT IT WAS ¿DETERIORATION DUE TO CAROTID REOCCLUSION.¿ THE LEFT ICA RE-OCCLUSION EVENT WAS ASSESSED TO BE UNRELATED TO THE EMBOVAC DEVICE BUT BEING POSSIBLY RELATED TO THE PRIMARY PROCEDURE. SINCE THE EMBOVAC DEVICE WAS USED DURING THE PROCEDURE AT THE ICA TARGET SITE, THE CORRELATION BETWEEN EVENT TO THE USED DEVICE CANNOT BE RULED OUT ENTIRELY. THEREFORE, THIS EVENT MEETS 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. UPDATED SECTIONS: B.4, G.3, G.6, H.2, AND H.11. 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.
MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO INCLUDE THE ADDITIONAL INFORMATION RECEIVED ON 22-JUL-2025. THIS MDR SUBMISSION ALSO INCLUDES THE COMPLETE PRIMARY UDI NUMBER OF THE EMBOVAC DEVICE. [ADDITIONAL INFORMATION]: ON 22-JUL-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE ADVERSE EVENT PROGRESSION OF INDEX STROKE WAS DETERMINED TO BE A RE-OCCLUSION OF THE LEFT INTERNAL CAROTID ARTERY (ICA). THE LEFT ICA RE-OCCLUSION EVENT WAS ASSESSED TO BE UNRELATED TO THE EMBOVAC DEVICE BUT BEING POSSIBLY RELATED TO THE PRIMARY PROCEDURE. SINCE THE EMBOVAC DEVICE WAS USED DURING THE PROCEDURE AT THE ICA TARGET SITE, THE CORRELATION BETWEEN EVENT TO THE USED DEVICE CANNOT BE RULED OUT ENTIRELY. THEREFORE, THIS EVENT MEETS 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. UPDATED SECTIONS: B.4, D.4, G.3, G.6, H.2, AND H.11. 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.
THE EVENT WAS REPORTED VIA THE EXCELLENT STUDY, THE 71-YEAR-OLD MALE PATIENT WITH A HISTORY OF DEEP VEIN THROMBOSIS (DVT) AND PERIPHERAL ARTERY DISEASE (PAD), PRESENTED WITH A WITNESSED STROKE ON (B)(6) 2024 AT 08:00 HOUR. THE PATIENT WAS PRESENTED TO THE TREATING HOSPITAL ON (B)(6) 2024, TIME UNKNOWN. 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 10. THE MODIFIED RANKIN SCALE (MRS) WAS NOT AVAILABLE AT THE TIME OF THE COMPLAINT INITIATION / REVIEW. ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY USING AN EMBOVAC LARGE BORE 71 CATHETER (IC71132UG / 31202405) TARGETING OCCLUSIONS IN THE LEFT INTERNAL CAROTID ARTERY (ICA) AND THE LEFT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). THE PRE-PASS MODIFIED THROMBOLYSIS IN CEREBRAL INFARCTION (MTICI) SCORE WAS 0. THE FIRST PASS WAS MADE USING THE DIRECT CONTACT ASPIRATION DEVICE ALONE AT THE ICA SITE, WHICH RESULTED IN A MTICI SCORE OF 0, WITH CLOT RETRIEVAL. THE SECOND PASS WAS MADE USING THE DIRECT CONTACT ASPIRATION DEVICE ALONE AT THE M2 SITE, WHICH RESULTED IN A MTICI SCORE OF 3, WITH NO CLOT RETRIEVAL. A GUIDEWIRE (UNSPECIFIED BRAND), A TREVO TRAK¿ 21 MICROCATHETER (STRYKER), AND A WALRUS¿ 8F BALLOON CATHETER (Q¿APEL) WERE ALSO USED DURING THE PROCEDURE. THERE WERE NO INTRAOPERATIVE STUDY DEVICE DEFICIENCIES. THE PATIENT¿S 24-HOUR POST-PROCEDURE NIHSS SCORE WAS 15. THE PATIENT EXPERIENCED THE ADVERSE EVENT, TRACE PETECHIAL HEMORRHAGE IN THE FRONTAL OPERCULUM ON (B)(6) 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 CEREGLIDE71, 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 |
|---|---|---|---|---|---|---|---|
| 2508156 | 132CM LARGE BORE 71 CATHETER | CATHETER, ASPIRATION CATHETER | NRY | MEDOS INTERNATIONAL SARL | 31202405 | 10886704082378 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Male | Life Threatening | GUIDEWIRE (UNSPECIFIED BRAND).| TREVO TRAK¿ 21 MICROCATHETER (STRYKER).| WALRUS¿ 8F BALLOON CATHETER (Q¿APEL). |