CERENOVUS ENTERPRISE
Report
- Report Number
- 3008114965-2026-00213
- Event Type
- Injury
- Date Received
- February 3, 2026
- Date of Event
- January 13, 2026
- Report Date
- March 3, 2026
- Manufacturer
- MEDOS INTERNATIONAL SARL
- Product Code
- NJE
- UDI-DI
- 10886704044000
- PMA / PMN Number
- H60001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
MANUFACTURER REF# (B)(4). UPDATED SECTIONS ON THIS MEDWATCH: B4, G3, G6, H2, H6 AND H11. PROCEDURAL IMAGE WAS REVIEWED BY AN INDEPENDENT PHYSICIAN, AND THE RESULTS ARE SHOWN BELLOWS: ¿THE IMAGE IS A SINGLE 2D PA ANGIOGRAPHIC IMAGE. IT IS UNCLEAR AT WHAT POINT DURING THE PROCEDURE THE IMAGE WAS TAKEN. AT LEAST ONE STENT IS VISIBLE (POSSIBLY TWO) WITHIN THE REGION OF THE INTERNAL CAROTID ARTERY. THERE ARE IRREGULARITIES NOTED IN THE INTERNAL CAROTID ARTERY, WHICH MAY REPRESENT EITHER CALCIFICATION OR POSSIBLY A DISSECTION OF THE VESSEL (ALTHOUGH THIS WAS NOT REPORTED). BOTH SCENARIOS COULD EXPLAIN THE DIFFICULTY ENCOUNTERED WITH STENT DEPLOYMENT. ONLY LIMITED INFORMATION HAS BEEN OBTAINED, AND NO PRE-OPERATIVE IMAGES ARE AVAILABLE FOR COMPARISON. SUMMARY: BASED ON THE INFORMATION PROVIDED AND THE SINGLE IMAGE IT IS NOT POSSIBLE TO DRAW ANY FIRM CONCLUSIONS ON THE CAUSE OF THE DIFFICULTIES DESCRIBED.¿ A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.
MANUFACTURER REF# (B)(4) INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. SECTION E1. INITIAL REPORTER PHONE: (B)(6). INTERFERENCE OR FRICTION BETWEEN DEVICES IS A KNOWN OCCURRENCE. REMOVAL AND EXCHANGE OF DEVICES IS COMMON ROUTINE PRACTICE IN ENDOVASCULAR PROCEDURES. IF RESISTANCE IS ENCOUNTERED, THE SYSTEM BEING INSERTED SHOULD BE WITHDRAWN AS A UNIT TO PREVENT INJURY. IN THIS CASE IT IS DONE WITHOUT LOSS OF INTRACRANIAL TARGET POSITION. THIS IS A COMMON PRACTICE DURING PROCEDURES AND IS RECOMMENDED IN PRODUCT IFU¿S. SINCE THE VAST MAJORITY OF DIAGNOSTIC AND INTERVENTIONAL ANGIOGRAPHIC PROCEDURES UTILIZE MULTIPLE DEVICE EXCHANGES, AN INCREASED POTENTIAL FOR PATIENT INJURY IS REMOTE. THERE ARE CLINICAL AND PROCEDURAL FACTORS, INCLUDING VESSEL CHARACTERISTICS, DEVICE INTERACTION, AND OPERATOR TECHNIQUE, THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. ALTHOUGH THE DEVICE WAS SUCCESSFULLY IMPLANTED WITHOUT LOSS OF INTRACRANIAL TARGET POSITION, THE ALLEGED DEVICE DEFICIENCY MAY HAVE CONTRIBUTED TO A SIGNIFICANT PROCEDURAL DELAY. IN THE CONTEXT OF A DISRUPTED BLOOD-BRAIN BARRIER AND INCREASED CONTRAST VOLUME ADMINISTRATION, A SIGNIFICANT PROCEDURAL DELAY CAN FURTHER CONTRIBUTE TO THE ONSET AND SEVERITY OF CONTRAST-INDUCED ENCEPHALOPATHY. BASED ON THIS INFORMATION, THIS EVENT DOES MEET US FDA REPORTING CRITERIA UNDER 21 CFR 803 WITH A CLASSIFICATION OF A ¿SERIOUS INJURY,¿ WITH AN AWARENESS DATE OF 12-JAN-2026. 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. 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.
MANUFACTURER REF# (B)(4). UPDATED SECTIONS ON THIS MEDWATCH: B4, D9, G3, G6, H2, H3, H6 AND H11. THE DEVICE WAS RETURNED TO J&J MEDTECH FOR FURTHER EVALUATION. A NON-STERILE EU 4.5X37MM STENT 12 MM DW TIP WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. UPON RECEIVING THE DEVICE, VISUAL INSPECTION WAS PERFORMED, AND THE STENT WAS DETACHED FROM THE DELIVERY SYSTEM AND IT WAS NOT RETURNED FOR EVALUATION. NO APPEARANCE OF DAMAGE WAS OBSERVED. A DEVICE HISTORY RECORD (DHR) WAS PERFORMED, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE ISSUE REGARDING RESISTANCE DURING ADVANCEMENT OF THE DEVICE CANNOT BE EVALUATED THROUGH FUNCTIONAL TESTING. THE STENT MUST BE INSIDE THE INTRODUCER TUBE TO PERFORM THE FUNCTIONAL ANALYSIS. ADDITIONALLY, NONE OF THE RETURNED COMPONENTS PRESENT DAMAGES THAT SUGGEST THAT THEY WERE FORCIBLY ADVANCED. WITH THE LIMITED INFORMATION AVAILABLE, A CONCLUSIVE CAUSE CANNOT BE DETERMINED; HOWEVER, IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION AND OPERATOR'S TECHNIQUE, MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. AT THIS TIME, THERE IS NO EVIDENCE TO SUPPORT THAT THE ISSUE REPORTED IN THE COMPLAINT IS A RESULT OF A DEFECT INHERENTLY RELATED TO THE DEVICE. THE STENT COMPONENT MIGHT HAVE GOTTEN LOST SOMETIME DURING THE POST-OPERATIVE HANDLING OF THE DEVICE. IF ADDITIONAL INFORMATION OR COMPONENTS ARE RECEIVED AT A LATER TIME, THIS INVESTIGATION WILL BE REASSESSED ACCORDINGLY. THE STENT DETACHMENT IS NOT CONSIDERED RELATED TO THE ENCOUNTERED ISSUE. AS PART OF THE J&J MEDTECH QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO INTERNAL ACTION IS REQUIRED. IT SHOULD BE NOTED THAT PRODUCT FAILURE COULD BE CAUSED BY MULTIPLE FACTORS. THE INSTRUCTIONS FOR USE (IFU) DO CONTAIN THE FOLLOWING RECOMMENDATIONS: ¿ IF RESISTANCE IS MET DURING MANIPULATION, DETERMINE THE CAUSE OF RESISTANCE BEFORE PROCEEDING. ¿ DO NOT APPLY UNDUE FORCE IF RESISTANCE IS ENCOUNTERED AT ANY POINT DURING STENT MANIPULATION. WITHDRAW THE UNIT AND ADVANCE A NEW ONE. 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. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.
MANUFACTURER REF# (B)(4) CORRECTION: THE DEVICE HISTORY RECORD REVIEW WAS INADVERTENTLY OMITTED FROM THE INITIAL MEDWATCH REPORT (B)(4). SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED AND THE REPORTED FAILURE COULD NOT BE EVALUATED. A DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND IT INDICATED THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.
IT WAS REPORTED, VIA HEALTHCARE PROFESSIONAL, THAT AN EU 4.5X37MM STENT 12 MM DW TIP (ENC453712/ 9493895), EU 4.5X37MM STENT 12 MM DW TIP (ENC453712/ 9309016), ENTERPRISE2 4MMX39MM NO TIP (ENCR403900/ 9664732), PROWLER SELECT PLUS 150/5CM (606S255X/ 31667098) AND A PROWLER SELECT PLUS 150/5CM (606S255X/ 31667098) WERE USED FOR AN INTRACRANIAL ANGIOPLASTY. DURING THE PROCEDURE, THE USER REPORTED OBSTRUCTION WHILE IN PATIENT WITH LOSS OF CEREBRAL TARGET POSITION OF ONE OF THE PROWLER SELECT PLUS MICROCATHETERS (IP-(B)(4)), ENTERPRISE IMPEDIMENT IN MICROCATHETER AND WITHDRAWAL DIFFICULTY-THROUGH MICROCATHETER WITH LOSS OF CEREBRAL TARGET (IP-(B)(4)), ENTERPRISE RESISTANCE/FRICTION WITH NO LOSS OF CEREBRAL TARGET POSITION (IP-(B)(4)), AND ENTERPRISE2 IMPEDIMENT IN MICROCATHETER WITH NO LOSS OF CEREBRAL TARGET POSITION (IP-(B)(4)). THE EVENT WAS INITIALLY REPORTED AS SUCH, ¿THIS IS AN INTRACRANIAL ANGIOPLASTY PERFORMED DURING RECANALIZATION OF A CHRONIC OCCLUSION. ADEQUATE BLOOD FLOW COULD NOT BE MAINTAINED, THE SURGEON SELECTED EP TO PERFORM STENT IMPLANTATION. DURING THE PROCEDURE, THE FIRST STENT (INTENDED FOR DELIVERY TO THE DISTAL INTERNAL CAROTID ARTERY AT THE C6¿C7 SEGMENT) WAS IMPEDED IN THE MID AREA OF THE [MICROCATHETER] MC AND COULD NOT BE ADVANCED. DURING WITHDRAWAL, THE STENT WAS IMPEDED AT THE PROXIMAL PART OF THE MC AND COULD NOT BE RETRIEVED. THE WHOLE SYSTEM WAS REMOVED. THE 2ND STENT WAS DEPLOYED SMOOTHLY. THE 3RD STENT DELIVERED TO C4¿C5 SEGMENT WAS IMPED IN THE MID PART OF THE 2ND MC. THE SURGEON TRIED TO USE HIGHER FORCE TO ADVANCE, FINALLY DEPLOYED. THE 4TH STENT WAS IMPEDED AT THE PROXIMAL PART OF THE 2ND MC AND COULD NOT ADVANCE ANYMORE. THE SURGEON CHANGED TO THE 5TH STENT WITH THE 2ND MC TO DEPLOY SUCCESSFULLY AND FINALLY COMPLETED THE SURGERY. DUE TO THE IMPED ISSUES WHICH REQUIRED REPEATED EXCHANGES AND REESTABLISHING ACCESS, PROLONG THE PROCEDURE BY ABOUT 90 MINUTES; THE PATIENT LATER DEVELOPED CONTRAST INDUCED ENCEPHALOPATHY.¿ ADDITIONAL INFORMATION WAS PROVIDED ON 22-JAN-2026. SUMMARY: PER THE INFORMATION PROVIDED, THE NEUROLOGICAL SYMPTOM OBSERVED AFTER SURGERY WAS A LEFTWARD GAZE. THE CONTRAST ADMINISTERED WAS IODIXANOL; IT WAS REPORTED THAT THE TOTAL VOLUME ADMINISTERED WAS DOUBLED. THE CAUSE OF THE INITIAL VASCULAR OCCLUSION WAS THROMBOEMBOLISM. THE CAROTID ARTERY PRESENTED WITH MILD CALCIFICATION (NO PREOPERATIVE IMAGING) AND THE LENGTH OF THE OCCLUDED ARTERY PRE-PROCEDURE WAS ABOUT 10CM. NO FURTHER INFORMATION COULD BE OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 308670 | CERENOVUS ENTERPRISE | INTRACRANIAL NEUROVASCULAR STENT | NJE | MEDOS INTERNATIONAL SARL | 9309016 | 10886704044000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization |