CERENOVUS ENTERPRISE
Report
- Report Number
- 3008114965-2024-01147
- Event Type
- Malfunction
- Date Received
- November 25, 2024
- Date of Event
- November 7, 2024
- Report Date
- December 19, 2024
- Manufacturer
- MEDOS INTERNATIONAL SARL
- Product Code
- NJE
- UDI-DI
- 10886704071785
- PMA / PMN Number
- H60001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PRODUCT COMPLAINT # (B)(4). SECTION H3 - 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. 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 COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). 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.
PRODUCT COMPLAINT #(B)(4). ONE (1) PHOTO ACCOMPANIED THE COMPLAINT FILE. IN THE PHOTO, A DETACHED STENT CAN BE SEEN WITH A DELIVERY WIRE. THE STENT WAS OBSERVED TO BE IN GOOD CONDITION; THERE WAS NO STRUCTURAL DAMAGE (I.E., NO BROKEN STRUTS, NO KINKS); ALSO, IT WAS NOTED FULLY EXPANDED, BOTH ENDS CAN BE NOTED AS COMPLETELY FLARED. 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. THE ISSUE REPORTED REGARDING THE STENT BEING PREMATURELY SEPARATED FROM THE DELIVERY WIRE IS CONFIRMED BASED ON THE PHOTO RECEIVED. THIS INVESTIGATION WAS PERFORMED BASED ONLY ON THE PHOTO PROVIDED. AN ASSESSMENT WILL BE PERFORMED AS PER THE CONDITIONS OF THE DEVICE RETURNED. AS PART OF 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 CAPA ACTIVITY IS REQUIRED. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE.
PRODUCT COMPLAINT # ==> (B)(4). UPDATED SECTIONS ON THIS MED WATCH: B4, D9, G3, G6, H2, H3 AND H11. THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.
PRODUCT COMPLAINT # (B)(4). UPDATED SECTIONS ON THIS MED WATCH REPORT: B4, G3, G6, H2, H3, H6 AND H11. AS REPORTED BY THE FIELD, PRIOR TO USE, THE PHYSICIAN OPENED THE PACKAGING OF AN EU ENT4.5MMD 28MML WNO DSTL TP INTRACRANIAL STENT (ENC452800, 8962460) AND REMOVED THE DEVICE FROM DISPENSER HOOP. IT WAS FOUND THAT THE STENT WAS RELEASED AUTOMATICALLY. THE STENT BODY WAS SEPARATED PREMATURELY FROM THE DELIVERY WIRE. THE DEVICE WAS NOT USED IN PATIENT. THE PHYSICIAN SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY. ADDITIONAL EVENT INFORMATION RECEIVED ON 10-DEC-2024 INDICATED THAT THERE WERE NO PACKAGING ISSUES. THE INNER POUCH WAS SECURELY SEALED. ONE (1) PHOTO ACCOMPANIED THE COMPLAINT FILE. IN THE PHOTO, A DETACHED STENT CAN BE SEEN WITH A DELIVERY WIRE. THE STENT WAS OBSERVED TO BE IN GOOD CONDITION; THERE WAS NO STRUCTURAL DAMAGE (I.E., NO BROKEN STRUTS, NO KINKS); ALSO, IT WAS NOTED FULLY EXPANDED, BOTH ENDS CAN BE NOTED AS COMPLETELY FLARED. A NON-STERILE EU ENT4.5MMD 28MML WNO DSTL TP INTRACRANIAL STENT WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. UPON RECEIVING THE DEVICE, VISUAL INSPECTION WAS PERFORMED, AND AS DESCRIBED IN THE EVENT AND IN THE PHOTO ANALYSIS, THE STENT COMPONENT WAS DETACHED FROM THE DELIVERY UNIT. THE DISTAL END OF THE DELIVERY WIRE HAD MULTIPLE KINKED CONDITIONS AND DRIED SALINE RESIDUES. 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); ALSO, IT WAS NOTED FULLY EXPANDED, BOTH ENDS CAN BE NOTED AS COMPLETELY FLARED. THE DELIVERY WIRE WAS SUBJECTED TO DIMENSIONAL ANALYSIS AND ALL MEASUREMENTS THAT CONTROL THE ATTACHMENT AND DELIVERY OF THE STENT WERE FOUND WITHIN SPECIFICATIONS. THEREFORE, DEVICE FAILURE IS NOT SUSPECTED TO BE A CONTRIBUTING FACTOR. 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. THE ISSUE REPORTED REGARDING THE STENT RELEASING AUTOMATICALLY WAS CONFIRMED BASED ON THE DETACHED CONDITION OF THE STENT; HOWEVER, THE DAMAGES FOUND ON THE DELIVERY WIRE SUGGESTS THAT EXCESSIVE FORCE COULD HAD BEEN INADVERTENTLY APPLIED WHILE REMOVING THE DEVICE FROM THE DISPENSER HOOP SINCE AS PART OF J&J MEDTECH QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. DEVICES UNDERGO 100% INSPECTION AT DIFFERENT POINTS DURING THE MANUFACTURING PROCESS TO PREVENT DAMAGES FROM LEAVING THE FACILITY. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CAPA ACTIVITY 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: ¿ DO NOT PARTIALLY DEPLOY THE STENT FROM THE INTRODUCER. ¿ CONFIRM THAT THE DELIVERY WIRE DOES NOT MOVE RELATIVE TO THE INTRODUCER DURING THE REMOVAL OF THE CERENOVUS ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM FROM THE DISPENSER HOOP. ¿ CONFIRM THE TIP OF THE DELIVERY WIRE IS ENTIRELY WITHIN THE INTRODUCER. 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.
PRODUCT COMPLAINT # (B)(4). UPDATED SECTIONS ON THIS MED WATCH REPORT: B4, B5, G3, G6, H2, AND H11. SECTION B5: ADDITIONAL EVENT INFORMATION RECEIVED ON 10-DEC-2024 INDICATED THAT THERE WERE NO PACKAGING ISSUES. THE INNER POUCH WAS SECURELY SEALED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.
AS REPORTED BY THE FIELD, PRIOR TO USE, THE PHYSICIAN OPENED THE PACKAGING OF AN EU ENT4.5MMD 28MML WNO DSTL TP INTRACRANIAL STENT (ENC452800, 8962460) AND REMOVED THE DEVICE FROM DISPENSER HOOP. IT WAS FOUND THAT THE STENT WAS RELEASED AUTOMATICALLY. THE STENT BODY WAS SEPARATED PREMATURELY FROM THE DELIVERY WIRE. THE DEVICE WAS NOT USED IN PATIENT. THE PHYSICIAN SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1631396 | CERENOVUS ENTERPRISE | INTRACRANIAL NEUROVASCULAR STENT | NJE | MEDOS INTERNATIONAL SARL | 8962460 | 10886704071785 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |