CEREGLIDE
Report
- Report Number
- 3007628272-2025-00028
- Event Type
- Death
- Date Received
- June 16, 2025
- Report Date
- July 16, 2025
- Manufacturer
- CERENOVUS, INC.
- Product Code
- NRY
- UDI-DI
- 10886704085393
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, GENDER, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. SECTION B.2: DATE OF DEATH: THE DATE OF DEATH IS NOT KNOWN / REPORTED. SECTION B.3: DATE OF EVENT: THE DATE OF THE EVENT WAS NOT REPORTED / KNOWN. 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 (31457321) 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. BASED ON THE MANUFACTURING DOCUMENTATION REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. THE EXACT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS POSSIBLE THAT CIRCUMSTANCES OF THE PROCEDURE AND / OR DEVICE MANIPULATION / INTERACTION MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. VASCULAR DISSECTION IS A KNOWN COMPLICATION ASSOCIATED WITH THE USE OF THE CEREGLIDE71 CATHETER AND IS MENTIONED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. THERE WAS NO ALLEGED QUALITY ISSUE RELATED TO THE USE OF THE DEVICE, AS THE DEVICE PERFORMED AS INTENDED. THERE ARE CLINICAL AND PROCEDURAL FACTORS INCLUDING CLOT BURDEN, VESSEL CHARACTERISTICS, AND MECHANICAL MANIPULATION OF DEVICES THAT MAY HAVE CONTRIBUTED TO THE EVENT RATHER THAN A DEVICE DESIGN OR MANUFACTURING ISSUE. A VASCULAR DISSECTION DURING A THROMBECTOMY IS LIKELY ATTRIBUTED TO THE STENT-RETRIEVER OR GUIDEWIRE. AS EXPLAINED IN THE REFERENCED MEDICAL LITERATURE, STENT-RETRIEVERS (SR) GENERATE A SUSTAINED RADIAL FORCE TO THE VESSEL WALL TO TRAP THE THROMBUS CLOT, WHICH MAY CAUSE INJURY TO THE ENDOTHELIUM. HOWEVER, SINCE THE EVENT WAS AN INTRAPROCEDURAL FINDING AND OCCURRING SHORTLY AFTER THE USE OF THE CEREGLIDE71, THE RELATIONSHIP OF THE DEVICE TO THE REPORTED EVENT CANNOT BE EXCLUDED. A VASCULAR DISSECTION IS CLASSIFIED AS A SERIOUS INJURY, AS IT INVOLVES DAMAGE TO THE VASCULAR STRUCTURE THAT CAN LEAD TO LIFE-THREATENING BLEEDING OR COMPROMISED BLOOD FLOW TO VITAL ORGANS. THE SEVERITY OF THIS EVENT IS CURRENTLY UNKNOWN. BASED ON THIS INFORMATION, THIS EVENT MEETS US FDA REPORTING CRITERIA UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿SERIOUS INJURY.¿ REFERENCE: LEE IH, HA SK, LIM DJ, CHOI JI. PREDICTORS OF INTRACRANIAL HEMORRHAGE AFTER MECHANICAL THROMBECTOMY USING A STENT-RETRIEVER FOR ANTERIOR CIRCULATION ISCHEMIC STROKE: A RETROSPECTIVE STUDY. MEDICINE (BALTIMORE). 2023 JAN 13;102(2):E32666. DOI: 10.1097/MD.0000000000032666. PMID: 36637951; PMCID: PMC9839270. PER THE ADDITIONAL INFORMATION RECEIVED ON 09-JUN-2025, IT WAS CLARIFIED THAT THE VASCULAR DISSECTION OCCURRED AT THE ORIGIN OF ACA RATHER THAN A2, AND A HEMORRHAGE ALSO OCCURRED AT THE SAME LOCATION. BASED ON THIS INFORMATION AND THE LOCATION OF THE CEREGLIDE71 DEVICE AT THE TIME OF THE EVENTS, THE CORRELATING RELATIONSHIP BETWEEN THE EVENTS OF ¿VASCULAR DISSECTION AND CEREBRAL HEMORRHAGE¿ TO THE USED CEREGLIDE71 DEVICE AS A CONTRIBUTING FACTOR CANNOT BE RULED OUT ENTIRELY. ADDITIONALLY, INFORMATION RECEIVED ON 02-JUN-2025 STATES A CONTRALATERAL RIGHT A2 OCCLUSION WAS FOUND AFTER THE FIRST PASS USING THE CEREGLIDE71 DEVICE; IT IS POSSIBLE THIS WAS A DISTAL EMBOLIZATION OF THE ORIGINAL THROMBUS, FOR WHICH THE CEREGLIDE71 DEVICE AS A CONTRIBUTING OR CAUSAL FACTOR CANNOT BE RULED OUT. WHILE THE CAUSE OF THE HEMORRHAGE IN THE POSTERIOR AREA REMAINS UNKNOWN, THE HEMORRHAGE IN THE ANTERIOR CIRCULATION MAY HAVE CONTRIBUTED TO COMPRESSION OF THE BRAINSTEM, WHICH ULTIMATELY RESULTED IN THE PATIENT¿S DEATH. THEREFORE, THE EVENTS OF ¿DISTAL EMBOLIZATION, VASCULAR DISSECTION, CEREBRAL HEMORRHAGE, AND DEATH¿ MEETS US FDA REPORTING CRITERIA UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿DEATH.¿ 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. 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 EVENT INFORMATION RECEIVED ON 17-JUN-2025. [ADDITIONAL INFORMATION]: ON 17-JUN-2025, LIMITED ADDITIONAL INFORMATION WAS RECEIVED. THE ADDITIONAL INFORMATION INDICATED THAT THE HEMORRHAGE IN THE ANTERIOR CIRCULATION WAS CAUSED BY THE ACA DISSECTION, BUT THE CAUSE OF THE HEMORRHAGE IN THE POSTERIOR AREA (BRAINSTEM) WAS UNKNOWN. INFORMATION REGARDING THE HEMORRHAGE IN THE POSTERIOR AREA IS NOT AVAILABLE AT THIS TIME; WHEN INFORMATION IS AVAILABLE, IT WILL BE REPORTED / ADDED TO THE COMPLAINT FILE. 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 EVENT INFORMATION RECEIVED ON 16-JUL-2025. [ADDITIONAL INFORMATION]: ON 16-JUL-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PATIENT WAS AN 80-YEAR-OLD FEMALE. THE PATIENT EXPIRED THE SAME DAY AS THE PROCEDURE (THE PROCEDURE DATE WAS UNKNOWN / UNOBTAINABLE). THE OFFICIAL CAUSE OF DEATH WAS RESPIRATORY FAILURE DUE TO BRAINSTEM HERNIATION. THE INFORMATION INDICATED THAT THE VASCULAR TORTUOSITY WAS NOT SEVERE, ¿BUT THERE WAS A FEELING OF STUCK AT THE SITES OF TORTUOSITY FROM THE ICA TO THE ACA (WHICH WAS OF NORMAL TORTUOSITY DEGREE), MAKING IT DIFFICULT TO ADVANCE [THE] CEREGLIDE 71. THE CEREGLIDE 71 MADE A TOTAL OF TWO PASSES. THE HEMORRHAGE SUFFERED BY THE PATIENT WAS A SUBARACHNOID HEMORRHAGE. THE CT SCAN WAS DONE AFTER THE PLANNED PROCEDURE WAS COMPLETED. PER THE ADDITIONAL INFORMATION RECEIVED ON 16-JUL-2025, IT WAS DISCLOSED THAT THE HEMORRHAGE WAS CLASSIFIED AS A SUBARACHNOID HEMORRHAGE. ADDITIONALLY, IT WAS REPORTED THAT THERE WAS DIFFICULTY ADVANCING THE CEREGLIDE 71 CATHETER THROUGH SITES OF TORTUOSITY FROM THE ICA TO THE ACA. DIFFICULTY TRACKING A CATHETER THROUGH THE VASCULATURE IS A KNOWN PROCEDURAL OCCURRENCE. THE CONSEQUENCES OF TRACKING DIFFICULTY OCCURRING DURING CLINICAL USE OF THE DEVICE ARE USUALLY ADDRESSED BY MODIFICATION IN TECHNIQUE OR SUBSTITUTION WITH ANOTHER DEVICE. TRACKING DIFFICULTY IS MOST COMMONLY RELATED TO PATIENT ANATOMY, OPERATOR TECHNIQUE, AND APPROPRIATE DEVICE SELECTION. THEREFORE, THE POTENTIAL FOR PATIENT INJURY/DEATH OCCURRING AS A RESULT OF ANY TRACKING DIFFICULTY IS REMOTE. THERE IS NO INDICATION THAT THE TRACKING DIFFICULTY ENCOUNTERED AT TORTUOUS BENDS OF THE VESSEL CONTRIBUTED TO THE ADVERSE EVENTS REPORTED. THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. UPDATED SECTIONS: A.2, B.4, G.3, G.6, H.2, H.6, 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 HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE TO TREAT AN ACUTE ISCHEMIC STROKE TARGETING THE ANTERIOR CEREBRAL ARTERY (ACA), DEVICES WERE USED IN ACCORDANCE WITH THEIR RESPECTIVE INSTRUCTIONS FOR USE (IFUS). THE PROCEDURE WAS PERFORMED VIA THE COMBINED TECHNIQUE USING THE 132CM CEREGLIDE 71 CATHETER (NIC71132C / 31457321), AXS VECTA 46® INTERMEDIATE CATHETER (STRYKER), AND TREVO® STENT RETRIEVER (STRYKER). AFTER THE 8FR OPTIMO® BALLOON GUIDE CATHETER (BGC) (TOKAI MEDICAL) WAS PLACED IN THE INTERNAL CAROTID ARTERY, THE THROMBUS WAS RETRIEVED BY THE TREVO STENT RETRIEVER USING THE CEREGLIDE 71 CATHETER AND THE AXS VECTA 46. THE THROMBUS WAS REMOVED, BUT A VASCULAR DISSECTION OCCURRED. CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE. THE PATIENT¿S MOST CURRENT CONDITION WAS NOT KNOWN AT THE TIME OF THE COMPLAINT INITIATION. ON (B)(6) 2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, RELATED TO THE FIRST PASS: THE TARGET LESION WAS THE LEFT INTERNAL CAROTID TOP OCCLUSION. AFTER THE 8FR OPTIMO® BGC WAS PLACED IN INTERNAL CAROTID ARTERY, THE THROMBUS WAS RETRIEVED BY A DIRECT ASPIRATION FIRST PASS TECHNIQUE (ADAPT) TECHNIQUE USING THE CEREGLIDE 71. ¿AFTER THE FIRST PASS, THE PHYSICIAN FOUND A CONTRALATERAL RIGHT A2 OCCLUSION, THE DEVICES APPROACHED THE LESION FROM THE SAME SIDE.¿ RELATED TO THE SECOND PASS, THE CEREGLIDE 71 WAS USED AS A DISTAL ACCESS CATHETER, AND IT WAS PLACED AT THE INTERNAL CAROTID (IC)-ANTERIOR CEREBRAL ARTERY (AC) BIFURCATION. THE AXS VECTA 46 WAS PLACED AT THE ORIGIN OF THE ACA. THE THROMBUS WAS THEN RETRIEVED BY THE COMBINED TECHNIQUE USING THE 3MM TREVO STENT RETRIEVER. POST-OPERATIVE CT REVEALED A VASCULAR DISSECTION AT THE ORIGIN OF THE A2. ADDITIONALLY, A HEMORRHAGE OF UNKNOWN CAUSE WAS OBSERVED EXTENSIVELY IN THE POSTERIOR AREA, LEADING TO COMPRESSION OF THE BRAINSTEM AND RESULTING IN RESPIRATORY DISORDER; HOWEVER, ADDITIONAL INTERVENTION COULD NOT BE PERFORMED, AND THE PROCEDURE WAS TERMINATED. THE PATIENT PASSED AWAY. THE INFORMATION INCLUDED THE PHYSICIAN¿S COMMENT: ¿VASCULAR DISSECTION AT THE ORIGIN OF THE ACA MAY HAVE OCCURRED DUE TO FORWARD ADVANCEMENT DURING STENT RETRIEVER TRACTION OR BECAUSE VECTA 46 WAS TOO ADVANCED. SINCE THE CEREGLIDE 71 WAS PLACED PROXIMAL TO THE ACA, I BELIEVED THERE WAS NO CAUSAL RELATIONSHIP WITH THE HEMORRHAGE. GENERALLY, IT IS UNLIKELY THAT HEMORRHAGE IN THE ANTERIOR CIRCULATION CAUSES HEMORRHAGE IN THE POSTERIOR AREA (BRAINSTEM), SO THE CAUSE REMAINS UNKNOWN.¿ ON (B)(6) 2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE VASCULAR DISSECTION OCCURRED AT THE ORIGIN OF ACA RATHER THAN A2, AND HEMORRHAGE ALSO OCCURRED AT THE SAME LOCATION. HEMORRHAGE WAS ALSO CONFIRMED IN THE POSTERIOR AREA. THE ADDITIONAL INFORMATION ALSO CLARIFIED THE STATEMENT RELATED TO THE FIRST PASS. ON (B)(6) 2025, THE FIRST PASS TARGETED THE LEFT INTERNAL CAROTID TOP OCCLUSION. AFTER THE 8FR OPTIMO® BGC WAS PLACED IN INTERNAL CAROTID ARTERY, THE THROMBUS WAS RETRIEVED BY A DIRECT ASPIRATION FIRST PASS TECHNIQUE (ADAPT) TECHNIQUE USING THE CEREGLIDE 71. ¿AFTER THE FIRST PASS, THE PHYSICIAN FOUND A CONTRALATERAL RIGHT A2 OCCLUSION, THE DEVICES APPROACHED THE LESION FROM THE SAME SIDE. THE CLARIFICATION IS RELATED TO THE ¿SAME SIDE¿ THE SAME SIDE IN THIS CONTEXT IS ¿THE LEFT SIDE.¿ BASED ON THE ADDITIONAL INFORMATION RECEIVED ON 02-JUN-2025 THAT WAS FURTHER CLARIFIED ON 09-JUN-2025, THE EVENT HAS BEEN DEEMED USFDA REPORTABLE UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿DEATH.¿
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1008605 | CEREGLIDE | CATHETER, THROMBUS RETRIEVER | NRY | CERENOVUS, INC. | 31457321 | 10886704085393 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Female | Life Threatening| D | 8F LONG SHEATH (UNSPECIFIED BRAND).| AXS VECTA 46® INTERMEDIATE CATHETER (STRYKER).| OPTIMO® BALLOON GUIDE CATHETER ((B)(6) MEDICAL).| TREVO® STENT RETRIEVER (STRYKER). |