ENTERPRISE2 4MMX23MM
Report
- Report Number
- 3008114965-2022-00770
- Event Type
- Injury
- Date Received
- November 28, 2022
- Date of Event
- November 9, 2022
- Report Date
- January 10, 2023
- Manufacturer
- MEDOS INTERNATIONAL SARL
- Product Code
- NJE
- 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
PRODUCT COMPLAINT # (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. (B)(6). 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. 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 MEDWATCH: B4, B5, G3, G6, H2, H6 AND H10. COMPLAINT CONCLUSION: IT WAS REPORTED THAT DURING A STENT-ASSISTED COIL EMBOLIZATION OF AN ANTERIOR COMMUNICATING ARTERY (ACA) ANEURYSM, THE PHYSICIAN DELIVERED THE 4.5MM X 22MM ENTERPRISE STENT (ENCR402312/ 7000290) AT THE TARGET POSITION AND RELEASE THE DEVICE, HOWEVER THE STENT TIP COULD NOT BE OPENED COMPLETELY. IT WAS REFERRED THAT THE PHYSICIAN USED OTHER BRAND WIRE TO ¿MASSAGE¿ THE STENT TIP, BUT IT STILL COULD NOT BE OPENED FULLY. THE PHYSICIAN THEN USED AND RELEASED A SECOND STENT TO COMPLETE THE SURGERY. THE PROCEDURE WAS PROLONGED ABOUT 10 MINUTES AND THE PATIENT WAS STABLE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE TEMPERATURE INDICATOR LABEL ON THE INNER POUCH WAS CHECKED AND FOUND TO BE WITHIN ACCEPTABLE CRITERIA. THERE WAS NO RESISTANCE DURING THE ADVANCEMENT OF THE DEVICE. THE STENT DID NOT APPEAR DAMAGED. THERE WERE NO VESSEL OR ANEURYSM FACTORS THAT MAY HAVE CONTRIBUTED TO THE INCOMPLETE EXPANSION. THERE WAS NO BLOOD FLOW RESTRICTION. THE DEVICE REMAINS IMPLANTED; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. 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. INCOMPLETE STENT EXPANSION REQUIRING ADDITIONAL INTERVENTION ARE KNOWN COMPLICATIONS ASSOCIATED WITH THE ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND ARE LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. INCOMPLETE EXPANSION COULD LEAD TO THROMBOSIS AND/OR MIGRATION OR EMBOLIZATION, RESULTING IN ISCHEMIA OR INFARCT. SINCE THE ALLEGED INCOMPLETE STENT EXPANSION REQUIRED ADDITIONAL INTERVENTION (I.E., USE OF A GUIDEWIRE TO MASSAGE THE STENT TIP) IN AN EFFORT TO FULLY EXPAND THE STENT AND PRECLUDE PATIENT COMPLICATIONS AND THE USE OF A SECOND STENT DEVICE TO CONCLUDE THE PROCEDURE, THE EVENT MEETS MDR REPORTING CRITERIA WITH THE CLASSIFICATION OF ¿SERIOUS INJURY¿. THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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 MEDWATCH: B4, B5, G3, G6, H2 AND H10. SECTION B5: ADDITIONAL INFORMATION WAS RECEIVED ON 29-NOV-2022 INDICATING THAT THE TEMPERATURE INDICATOR LABEL ON THE INNER POUCH WAS CHECKED AND FOUND TO BE WITHIN ACCEPTABLE CRITERIA. THERE WAS NO RESISTANCE DURING THE ADVANCEMENT OF THE DEVICE. THE STENT DID NOT APPEAR DAMAGED. THERE WERE NO VESSEL OR ANEURYSM FACTORS THAT MAY HAVE CONTRIBUTED TO THE INCOMPLETE EXPANSION. THERE WAS NO BLOOD FLOW RESTRICTION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.
IT WAS REPORTED THAT DURING A STENT-ASSISTED COIL EMBOLIZATION OF AN ANTERIOR COMMUNICATING ARTERY (ACA) ANEURYSM, THE PHYSICIAN DELIVERED THE 4.5MM X 22MM ENTERPRISE STENT (ENCR402312/ 7000290) AT THE TARGET POSITION AND RELEASE THE DEVICE, HOWEVER THE STENT TIP COULD NOT BE OPENED COMPLETELY. IT WAS REFERRED THAT THE PHYSICIAN USED OTHER BRAND WIRE TO ¿MASSAGE¿ THE STENT TIP, BUT IT STILL COULD NOT BE OPENED FULLY. THE PHYSICIAN THEN USED AND RELEASED A SECOND STENT TO COMPLETE THE SURGERY. THE PROCEDURE WAS PROLONGED ABOUT 10 MINUTES AND THE PATIENT WAS STABLE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2696254 | ENTERPRISE2 4MMX23MM | INTRACRANIAL NEUROVASCULAR STENT | NJE | MEDOS INTERNATIONAL SARL | 7000290 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Female | Required Intervention | NON J&J WIRE| UNSPECIFIED STENT |