CEREGLIDE
Report
- Report Number
- 3007628272-2025-00031
- Event Type
- Injury
- Date Received
- July 14, 2025
- Date of Event
- August 24, 2024
- Report Date
- July 21, 2025
- Manufacturer
- CERENOVUS, INC.
- Product Code
- NRY
- UDI-DI
- 10886704085393
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT DATE OF BIRTH AND GENDER WERE 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 (31246931) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO INTERNAL ACTIONS RELATED TO DEVICE MANUFACTURE OR INSPECTION. 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. THROMBOEMBOLISM IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THROMBECTOMY PROCEDURES AND IS ALSO LISTED IN THE CEREGLIDE71 CATHETER¿S INSTRUCTIONS FOR USE (IFU) AS SUCH. THERE WAS 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. THE EVENT OF AN EMBOLISM IN NEW TERRITORY WAS ASSESSED BY THE PI AS BEING POSSIBLY RELATED TO THE USED CEREGLIDE71 DEVICE AND POSSIBLY RELATED TO THE PRIMARY SURGICAL PROCEDURE; THEREFORE, THE CORRELATION BETWEEN THE EVENT TO THE USED DEVICE AS CONTRIBUTING FACTOR CANNOT BE RULED OUT. ADDITIONALLY, THE SEVERITY OF THE EVENT/IMPACT ON THE PATIENT IS UNKNOWN, AS THE PATIENT WAS LOST TO FOLLOW-UP, AND THE OUTCOME IS RECORDED AS ¿UNKNOWN.¿ BASED ON THIS INFORMATION, 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 LATER. 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 JOHNSON & JOHNSON MEDTECH, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, JOHNSON & JOHNSON MEDTECH, 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. 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 EVENT INFORMATION RECEIVED ON 17-JUL-2025. [ADDITIONAL INFORMATION]: ON 17-JUL-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE INITIAL OCCLUSION WAS IN THE M1 SEGMENT OF THE LEFT MIDDLE CEREBRAL ARTERY (MCA). THE INFORMATION ALSO INDICATED THE PRE-PROCEDURE TICI SCORE WAS 0 AND THE POST-PROCEDURE TICI SCORE WAS 2C WITH THE FOLLOWING: THE FIRST PASS WAS VIA ASPIRATION ONLY. RED CLOT REMOVED. ANGIOGRAPHY SHOWED RESIDUAL THROMBUS AT THE LEFT MCA BIFURCATION. THE SECOND PASS WAS ASPIRATION ONLY WITH FURTHER RED CLOT REMOVED. ANGIOGRAPHY SHOWED MULTIPLE DISTAL M2 OCCLUSIONS. THE THIRD PASS WAS ALSO VIA ASPIRATION ONLY WITH FRAGMENTED CLOT REMOVED. FURTHER ANGIOGRAPHY SHOWED ONGOING DISTAL M2 AND MORE DISTAL OCCLUSIONS, ¿BUT THERE WAS EXCELLENT COLLATERALIZATION. CONSENSUS DECISION TO PERFORM NO FURTHER PASSES.¿ THE ¿EMBOLISM IN NEW TERRITORY¿ WAS DISTINGUISHED FROM NEW OCCLUSIONS IN THE CONTEXT OF ¿CAROTID WEB THROMBUS¿ AS FOLLOWS, ¿IT WAS AN EMBOLISM IN A NEW TERRITORY AFTER USING THE DEVICE, IT WAS NOT PRESENT BEFORE USING THE DEVICE. IT IS THEREFORE UNLIKELY TO BE SECONDARY TO A NEW EMBOLISM FROM A DIFFERENT SOURCE.¿ THE ADDITIONAL INFORMATION ALSO INDICATED THAT ¿SCANS ARE ALREADY SENT AND UPLOADED.¿ HOWEVER, THE SCANS ARE NOT INCLUDED IN THE INFORMATION NOR ARE THEY IN THE COMPLAINT FILE. MODIFIED INFORMATION WAS RECEIVED ON 18-JUL-2025, RELATED TO THE ADVERSE EVENT ¿EMBOLISM IN NEW TERRITORY (SMALL PATCHY INFARCTS INVOLVING BASAL GANGLIA, LEFT INSULA, LEFT TEMPORAL OPERCULUM, LEFT POSTERIOR PARIETAL REGION AND THE LEFT PERICALLOSAL REGION,¿ THE SPONSOR AWARENESS DATE WAS UPDATED FROM "24-JUN-2025" TO "04-JUN-2025." NOTE, THE SPONSOR AWARENESS DATE IS TAKEN FROM NOTIFICATION RECORDS RECEIVED; THE SPONSOR AWARENESS DATE REMAINS 25-JUN-2025. 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.
THE EVENT WAS REPORTED VIA THE EXCELLENT STUDY, THE 29-YEAR-OLD FEMALE PATIENT WITH NO MEDICAL HISTORY PRESENTED WITH A WITNESSED STROKE ON (B)(6) 2024, AT 06:15 HOUR. THE PATIENT WAS PRESENTED TO THE TREATING HOSPITAL ON THE SAME DAY AT 09:55 HOUR, WHERE CT IMAGING CONFIRMED AN ISCHEMIC STROKE. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS ADMINISTERED AT THE TIME OF STROKE PRESENTATION. THE SUSPECTED ORIGIN OF THE EMBOLISM WAS ¿OTHER ETIOLOGIES: CAROTID WEB THROMBUS.¿ THE PATIENT¿S BASELINE NIHSS SCORE WAS 8 AND MODIFIED RANKIN SCALE SCORE MRS SCORE WAS ¿0-NO SYMPTOMS.¿ THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY ON THE SAME DAY, (B)(6) 2024. A 132CM CEREGLIDE 71 CATHETER (NIC71132C / 31246931) WAS USED DURING THE PROCEDURE. THE FIRST PASS MADE VIA DIRECT CONTACT ASPIRATION DEVICE ALONE TARGETED AN OCCLUSION IN THE M1 SEGMENT OF THE LEFT MIDDLE CEREBRAL ARTERY (MCA). THE PRE-PASS MTICI SCORE WAS 0. THE RESULTED MTICI SCORE OF 2B WITH CLOT RETRIEVAL WAS ACHIEVE AFTER THE FIRST PASS. THE SECOND PASS TARGETED AN OCCLUSION IN THE M2 SEGMENT OF THE LEFT MCA. THE POST-PASS MTICI WAS 2C WITH CLOT RETRIEVAL. DUE TO DIFFICULTY ACCESSING/CROSSING THE CLOT, THE ASPIRATION DEVICE WAS EXCHANGED FOR A 0.035 MAX INTERMEDIATE CATHETER FOR THE THIRD PASS, WHICH TARGETED THE OCCLUSION IN THE M3 SEGMENT OF THE LEFT MCA RESULTED IN AN MTICI SCORE OF 2C, WHICH CLOT RETRIEVAL. NO FURTHER PASSES WERE MADE. THERE WERE NO REPORTED INTRAOPERATIVE STUDY DEVICE DEFICIENCIES. THE PATIENT¿S 24-HOUR POST-PROCEDURE NIHSS SCORE WAS 2. THE FOLLOWING CONCOMITANT DEVICES WERE ALSO USED DURING THE PROCEDURE: A PHENOM¿ 21 MICROCATHETER (MEDTRONIC), A BALLAST¿ 088 LONG SHEATH (BALT), AND A GUIDEWIRE (UNSPECIFIED BRAND). THE PATIENT EXPERIENCED AN ¿EMBOLISM IN NEW TERRITORY (SMALL PATCHY INFARCTS INVOLVING BASAL GANGLIA, LEFT INSULA, LEFT TEMPORAL OPERCULUM, LEFT POSTERIOR PARIETAL REGION AND THE LEFT PERICALLOSAL REGION,¿ ON (B)(6) 2024. THIS EVENT WAS MADE KNOWN TO THE SITE ON 24-JUN-2025, AND TO THE SPONSOR ON (B)(6) 2025. THE PRINCIPAL INVESTIGATOR (PI) ASSESSED THIS EVENT AS NOT SERIOUS, MILD IN SEVERITY, BUT WITH SERIOUS DETERIORATION OF HEALTH. THE EVENT WAS DEEMED UNRELATED TO THE EMBOTRAP III STUDY DEVICE (NOT USED), UNRELATED TO THE EMBOVAC LARGE BORE CATHETER (NOT USED), POSSIBLY RELATED TO THE CEREGLIDE 71, AND POSSIBLY RELATED TO THE PRIMARY SURGICAL PROCEDURE. THE EVENT WAS NOT MEDICALLY TREATED. THE OUTCOME IS RECORDED AS ¿UNKNOWN¿ WITH NO END DATE LISTED. ON (B)(6) 2024, THE PATIENT WAS DISCHARGED TO ANOTHER HOSPITAL, WITH A MRS SCORE OF ¿2-SLIGHT DISABILITY; UNABLE TO CARRY OUT ALL PREVIOUS ACTIVITIES, BUT ABLE TO LOOK AFTER OWN AFFAIRS WITHOUT ASSISTANCE.¿ THE NIHSS ASSESSMENT WAS NOT PERFORMED. THE PATIENT¿S 90-DAY POST-PROCEDURE FOLLOW-UP ASSESSMENT WAS NOT PERFORMED DUE TO SUBJECT UNAVAILABILITY. ON (B)(6) 2024, THE PATIENT WAS DISCONTINUED FROM THE STUDY DUE TO BEING ¿LOST TO FOLLOW-UP.¿
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 145747 | CEREGLIDE | CATHETER, THROMBUS RETRIEVER | NRY | CERENOVUS, INC. | 31246931 | 10886704085393 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Female | Life Threatening | BALLAST¿ 088 LONG SHEATH (BALT)| GUIDEWIRE (UNSPECIFIED BRAND)| PHENOM¿ 21 MICROCATHETER (MEDTRONIC) |