CERENOVUS ENTERPRISE
Report
- Report Number
- 3008114965-2025-00123
- Event Type
- Malfunction
- Date Received
- February 21, 2025
- Date of Event
- February 5, 2025
- Report Date
- March 5, 2025
- Manufacturer
- MEDOS INTERNATIONAL SARL
- Product Code
- NJE
- UDI-DI
- 10886704043980
- PMA / PMN Number
- H60001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THE INVESTIGATIONAL FINDING OF THE RETURNED DEVICE. THE COMPLAINT PRODUCT WAS RETURNED AND RECEIVED FOR EVALUATION AND ANALYSIS. THE INVESTIGATION IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: A NON-STERILE 4.5MM X 22MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. VISUAL INSPECTION WAS PERFORMED. THE STENT COMPONENT WAS OBSERVED DETACHED FROM THE DELIVERY SYSTEM. THE DISTAL END OF THE DELIVERY WIRE WAS BROKEN NEXT TO THE RETRACTING BUMP, ALSO, WITH MULTIPLE KINKED CONDITIONS WERE NOTED ON IT. THESE CONDITIONS ARE CONSISTENT WITH THE DAMAGES SEEN ON THE PHOTO INCLUDED IN THE COMPLAINT. MICROSCOPIC INSPECTION WAS PERFORMED ON THE STENT COMPONENT. IT WAS OBSERVED TO BE IN GOOD CONDITION; THERE WAS NO STRUCTURAL DAMAGE (I.E., NO BROKEN STRUTS, NO KINKS). IT WAS NOTED TO BE FULLY EXPANDED WITH BOTH ENDS COMPLETELY FLARED. THE DISTAL COIL OF THE DELIVERY WIRE WAS FOUND STRETCHED. THE BROKEN CONDITION OF THE DELIVERY WIRE SUGGEST THAT THE DELIVERY WIRE WAS PUSHED OR RETRACTED AGAINST RESISTANCE SUFFICIENTLY TO CAUSE THE DELIVERY WIRE TO BREAK AND DISENGAGE THE STENT INSIDE THE INTRODUCER. THEREFORE, THE REPORTED ISSUE IN THE COMPLAINT CAN BE CONFIRMED. THERE IS NO INDICATION THAT THE ISSUE REPORTED IN THE COMPLAINT IS A RESULT OF A DEFECT INHERENTLY RELATED TO THE DEVICE. LAKE REGION MEDICAL PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION, AND PACKAGING OF THE LOT 9061886. THE HISTORY RECORD INDICATES THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. AS PART OF JOHNSON & JOHNSON MEDTECH QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IT SHOULD BE NOTED THAT PRODUCT FAILURE COULD BE CAUSED BY MULTIPLE FACTORS. THE INSTRUCTIONS FOR USE (IFU) DOES 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. BASED ON THE MANUFACTURING DOCUMENTATION REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. 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. UPDATED SECTIONS: B.4, G.3, G.6. H.2, H.3, 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.
MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, SEX, GENDER, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. SECTION E.1: THE INITIAL REPORTER PHONE: (B)(6). SECTION H.3: THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING. HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. THE PRODUCT ANALYSIS TEAM REVIEWED THE PHOTO INCLUDED IN THE COMPLAINT. THE REVIEW IS DOCUMENTED BELOW. [PHOTO REVIEW]: IN THE PHOTO THE STENT OF AN ENTERPRISE SYSTEM CAN BE SEEN INSIDE THE INTRODUCER AND THE DISTAL END OF THE DELIVERY WIRE NEXT TO THE RETRACTION BUMP CAN BE SEEN BROKEN AND ATTACHED TO THE STENT COMPONENT. THE REST OF THE DELIVERY WIRE CAN BE SEEN WITH KINKED CONDITIONS. NO OTHER DAMAGES CAN BE SEEN. LAKE REGION MEDICAL PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION, AND PACKAGING OF THE LOT 9061886. THE HISTORY RECORD INDICATES THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE ISSUE REPORTED REGARDING THE SEPARATED CONDITION OF THE DELIVERY WIRE IS CONFIRMED BASED ON THE DAMAGES OBSERVED ON THE PHOTO; HOWEVER, THE ISSUE REPORTED REGARDING THE IMPEDED CONDITION OF THE STENT CANNOT BE EVALUATED THROUGH A PHOTO AS A FUNCTIONAL TEST ON THE PHYSICAL PRODUCT IS NEEDED. THIS INVESTIGATION WAS PERFORMED BASED ONLY ON THE PHOTO PROVIDED. AN ASSESSMENT WILL BE PERFORMED AS PER THE CONDITIONS OF THE DEVICE RETURNED. 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 REPORT THAT THE PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE ON 26-FEB-2025. A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED. UPDATED SECTIONS: B.4, D.9, G.3, G.6. H.2, H.3, 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 AN ENDOVASCULAR EMBOLIZATION PROCEDURE TARGETING A RIGHT INTERNAL CAROTID CAVERNOUS ANEURYSM, THE 4.5MM X 22MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC452212 / 9061886) WAS IMPEDED IN THE HUB OF THE CONCOMITANT REBAR¿ 18 MICROCATHETER (MEDTRONIC) AND COULD NOT BE FURTHER ADVANCED. THE PHYSICIAN RETRACTED ONLY THE STENT AND OBSERVED THAT THE DELIVERY WIRE BROKE. A PHOTO WAS INCLUDED IN THE COMPLAINT TO SHOW THE BROKEN DELIVERY WIRE. THE PHYSICIAN REPLACED THE ENTERPRISE STENT WITH ANOTHER STENT (COMPETITOR BRAND) TO COMPLETE THE PROCEDURE. THERE WAS NO NEGATIVE PATIENT IMPACT. THE PHOTO INCLUDED IN THE COMPLAINT WILL BE REVIEWED BY THE PRODUCT ANALYSIS TEAM. ON 11-FEB-2025, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION CONFIRMED THE PROCEDURE WAS TARGETING THE RIGHT INTERNAL CAROTID CAVERNOUS ANEURYSM. THE CONCOMITANT MICROCATHETER WAS A REBAR 18 MICROCATHETER. THE DELIVERY WIRE WAS NOT RESHAPED PRIOR TO USE. A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER DURING THE PROCEDURE. THE INTRODUCER WAS FULLY SEATED AND SECURED IN THE HUB. WHEN THE STENT WAS REMOVED, IT WAS STILL ON THE DELIVERY WIRE. THE DELIVERY WIRE BROKE (AS INDICATED IN THE PHOTO). THE INFORMATION CONFIRMED THERE WAS NO DELAY IN THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1619757 | CERENOVUS ENTERPRISE | INTRACRANIAL NEUROVASCULAR STENT | NJE | MEDOS INTERNATIONAL SARL | 9061886 | 10886704043980 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | REBAR¿ 18 MICROCATHETER (MEDTRONIC) |