ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
Report
- Report Number
- 1058196-2013-00167
- Event Type
- Malfunction
- Date Received
- June 19, 2013
- Date of Event
- May 8, 2013
- Report Date
- May 28, 2013
- Manufacturer
- CORDIS NEUROVASCULAR, INC.
- Product Code
- NJE
- PMA / PMN Number
- H60001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER
Narratives
THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS, AND ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
PER LAKE REGION REPORT (B)(4). LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10212471. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM SPECIALTY COATINGS SYSTEMS AND NITINOL DEVICES AND COMPONENTS, ALONG WITH LAKE REGION MEDICAL¿S INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
IT WAS REPORTED THAT THERE WAS MIGRATION OF THE ENTERPRISE VRD (ENC452200/1021247) DURING THE INDEX PROCEDURE. ADDITIONAL INFORMATION INDICATED THAT EVENT OCCURRED DURING TREATMENT OF AN UNRUPTURED 2MM SUPERIOR CEREBELLAR ARTERY (SCA) WIDE NECKED ANEURYSM AND NORMAL VESSEL WITH THE ENTERPRISE STENT IMPLANTED IN THE BASILAR ARTERY (BA) ¿ LEFT POSTERIOR CEREBRAL ARTERY (PCA) WITH GOOD WALL APPOSITION. THE STENT ENDED UP IN THE BA ¿ LEFT PCA AND CONTINUED TO COVER THE ANEURYSM NECK. THE VESSEL DIAMETER WAS APPROXIMATELY 2MM BA AND DISTAL PCA 3MM. THE STENT WAS NOT IMPLANTED AT AN ACUTE ANGLE, AND POST DEPLOYMENT, THE STENT EXTENDED 5MM BEYOND PROXIMAL AND DISTAL NECK. THERE WAS NO VESSEL STENOSIS. THE PROCEDURE WAS COMPLETED UNEVENTFULLY OTHERWISE (COILING NOT PERFORMED YET), AND THE ANEURYSM WAS NOT OBLITERATED. THERE ARE ADDITIONAL PROCEDURES PLANNED. PER LAKE REGION REPORT (B)(4). LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10212471. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM SPECIALTY COATINGS SYSTEMS AND NITINOL DEVICES AND COMPONENTS, ALONG WITH LAKE REGION MEDICAL¿S INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. RECEIVED IMAGES WERE SUBSEQUENTLY REVIEWED BY AN INDEPENDENT INTERVENTIONAL NEURORADIOLOGIST. IT WAS REPORTED THAT THE IMAGES WERE CALIBRATED FOR MEASUREMENTS. SUCH MEASUREMENTS WERE TAKEN USING DIGITAL JACKET SOFTWARE, AND THE IMAGES REPRESENTING SUCH MEASUREMENTS WERE SAVED AS TIF FILES IN THE APPROPRIATELY LABELED DIRECTORY STRUCTURE ON THE MEMORY CARD THAT WAS PROVIDED. THE CASE WAS REVIEWED WITH THE FOLLOWING QUESTIONS IN MIND: 1. WAS THE ANATOMY APPROPRIATE FOR DEVICE DEPLOYMENT, MEETING LABEL REQUIREMENTS? 2. WAS THE DEVICE PLACED APPROPRIATELY, WITH APPROPRIATE DISTAL AND PROXIMAL PARENT VESSEL COVERAGE? 3. WAS THERE ANY MANIPULATION DONE BEYOND STANDARD PRACTICES? REMOVING VRD DELIVERY CATHETER AND WIRE OR PLACING A MICROCATHETER INTO THE ANEURYSM CROSSING THE VRD STRUTS ARE CONSIDERED STANDARD PRACTICE. 4. CAN THE UNEXPECTED MOVEMENT OF THE VRD BY CONFIRMED? 5. HOW MUCH OF THE DISTAL PARENT VESSEL COVERAGE REMAINED AFTER MIGRATION? THE REVIEWER REPORTED THAT THE ANEURYSM IS LOCATED AS SITTING ON THE ¿SHOULDER¿ OF THE LEFT SUPERIOR CEREBELLAR ARTERY TAKEOFF. ITS SIZE IS 1.31X1.51 MM ON THE CALIBRATED IMAGE. SUCH A SMALL ANEURYSM IS GENERALLY CONSIDERED UNTREATABLE, UNLESS ONE ATTEMPTS A FLOW DIVERTER, OR THE ¿POOR MAN¿S FLOW DIVERTER¿, AN ENTERPRISE VRD. THE REVIEWER REPORTS HAVING DONE THAT BEFORE MULTIPLE TIMES AND THAT IT ACTUALLY WORKED. IN THIS CASE HOWEVER, THE ANEURYSM NECK IS FARTHER AWAY FROM THE BASILAR ARTERY, THE PARENT VESSEL WHERE THE VRD WAS PLACED. THIS WAY IT HAS NO OR JUST MINIMAL FLOW ALTERING EFFECT. A VRD WAS PLACED WITH DISTAL MARKERS IN THE LEFT PCA P2 SEGMENT, PROXIMAL MARKERS IN THE BASILAR ARTERY. DISTAL VESSEL DIAMETER IS 1.95 MM, PROXIMAL 3.17 MM. THE DISTAL PARENT VESSEL COVERAGE AT THE TIME OF DEPLOYMENT IS 13.51 MM AS SEEN ON RUN #9. AFTER DEPLOYING THE DEVICE FULLY AT 16:01:48, THE REVIEWER REPORTS SEEING A RATHER RAPID MOVEMENT OF THE DEVICE. INITIALLY NO OTHER DEVICES ARE PRESENT IN THE PARENT ARTERY ON #10 AND #11, YET THE DEVICE IS MOVING PROXIMALLY. ON #12 A MICROCATHETER - MICROWIRE COMBINATION IS PRESENT IN THE ARTERY. APPARENTLY THE OPERATOR ATTEMPTED CATHETERIZATION OF THE TINY ANEURYSM BY CROSSING THE STENT STRUTS TO THE LEFT. THESE ATTEMPTS CONTINUED UP TO #15 AT 16:26:10. THE DISTAL DEVICE MARKERS MOVED PROXIMALLY, TO THE VERY ORIGIN OF THE RIGHT PCA BY RUN #12. AFTER THAT RUN THERE IS NO FURTHER MOVEMENT. RUNS #17 AND #18 ARE APPARENTLY FOLLOW-UP IMAGES AFTER UNSUCCESSFUL CATHETERIZATION OF THE ANEURYSM. THE DEVICE REMAINED STABLE IN THE POSITION IT REACHED BY #12. EVENTUALLY THE ORIGINAL 13.51 MM DISTAL PA COVERAGE MELTED TO 1.90 MM BY THE END OF THE PROCEDURE. THE REVIEWER REPORTED THAT IT SEEMS LIKE CATHETER INTERACTION POSSIBLY FACILITATED PROXIMAL MOVEMENT OF THE VRD BUT THE CATHETER MANIPULATION DOESN¿T SEEM TO HAVE EXCEEDED NORMAL LEVELS. ALSO, THE VRD MOVED TO A LESSER DEGREE EVEN BEFORE CATHETER MANIPULATION STARTED. OVERALL, WATERMELON-SEEDING MOST LIKELY CONTRIBUTED SIGNIFICANTLY TO THE MOVEMENT; MANIPULATION WAS PROBABLY A MILD FACILITATOR. THE REVIEWER FURTHER SUMMARIZES THAT THE ENTERPRISE VRD DEVICE WAS PLACED APPROPRIATELY REGARDING THE TECHNIQUE AND THE DISTAL MARKER POSITION. HOWEVER, IT WAS PLACED IN A VERY SMALL VESSEL, 1.95MM IN THIS CASE, WHICH IS LESS THAN THE RECOMMENDED VESSEL DIAMETER OF 2.0-4.0 AS OUTLINED IN THE INSTRUCTIONS FOR USE. INITIAL PARENT VESSEL COVERAGE PROXIMALLY AND DISTALLY WAS GOOD. THERE WAS NO MANIPULATION WITH ANY OF THE DEVICES THAT WOULD EXCEED USUAL PRACTICE BY A TRAINED EXPERT. THE UNEXPECTED MOVEMENT OF THE VRD WAS CONFIRMED BY THE REVIEWER. IT WAS REPORTED THAT THE FACT THAT THE DEVICE WAS A ¿NO DISTAL TIP¿ HAD NO EFFECT ON THE RESULTS. THE DEVICE WAS PLACED ACCURATELY, DEPLOYMENT WAS NOT AN ISSUE. THE REVIEWER REPORTS THE MECHANISM OF WATERMELON SEEDING AS THE PRIMARY CAUSE OF DEVICE MIGRATION. DEVICE MANIPULATION BY THE OPERATOR WAS NOT AN IMPORTANT FACTOR. THE STENT REMAINS IMPLANTED. STENT MIGRATION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE ENTERPRISE VRD AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). WITH REVIEW OF THE AVAILABLE INFORMATION IT IS NOTED THAT THE DEVICE WAS IMPLANTED IN A VESSEL WITH A DIAMETER LESS THAN THE RECOMMENDED SIZE OF 2.0-4.0MM. VESSEL SIZE AND TAPER ARE FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT. A LARGE DIFFERENTIAL IN DIAMETER BETWEEN THE PROXIMAL AND DISTAL SEGMENTS OF THE PARENT VESSEL AS OUTLINED IN THE IFU IS A FACTOR THAT MAY INCREASE THE RISK OF STENT MIGRATION. THE STENT MIGRATION MAY HAVE BEEN IMPACTED BY CLINICAL FACTORS; WITH REVIEW OF THE DEVICE HISTORY RECORDS AND REPORTED INFORMATION, THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.
IT WAS REPORTED THAT THERE WAS MIGRATION OF THE ENTERPRISE VRD (ENC452200/10212471 DURING THE INDEX PROCEDURE. ADDITIONAL INFORMATION INDICATED THAT EVENT OCCURRED DURING TREATMENT OF AN UNRUPTURED 2MM SCA WIDE NECKED ANEURYSM AND NORMAL VESSEL WITH THE ENTERPRISE STENT IMPLANTED IN THE BASILAR ¿ LEFT PCA WITH GOOD WALL APPOSITION. THE STENT ENDED UP IN THE BASILAR ¿ LEFT PCA AND CONTINUED TO COVER THE ANEURYSM NECK. THE VESSEL DIAMETER WAS APPROXIMATELY 2MM BA AND DISTAL PCA 3MM. THE STENT WAS NOT IMPLANTED AT AN ACUTE ANGLE, AND POST DEPLOYMENT, THE STENT EXTENDED 5MM BEYOND PROXIMAL AND DISTAL NECK. THERE WAS NO VESSEL STENOSIS. THE PROCEDURE WAS COMPLETED UNEVENTFULLY OTHERWISE (COILING NOT PERFORMED YET), AND THE ANEURYSM WAS NOT OBLITERATED. THERE ARE ADDITIONAL PROCEDURES PLANNED. PER LAKE REGION REPORT C 13,350. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10212471. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM SPECIALTY COATINGS SYSTEMS AND NITINOL DEVICES AND COMPONENTS, ALONG WITH LAKE REGION MEDICAL¿S INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE STENT REMAINS IMPLANTED. STENT MIGRATION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE ENTERPRISE VRD AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). A LARGE DIFFERENTIAL IN DIAMETER BETWEEN THE PROXIMAL AND DISTAL SEGMENTS OF THE PARENT VESSEL AS OUTLINED IN THE IFU IS A FACTOR THAT MAY INCREASE THE RISK OF STENT MIGRATION. ALTHOUGH NO DEFINITIVE CONCLUSION CAN BE MADE, THE STENT MIGRATION MAY HAVE BEEN IMPACTED BY CLINICAL FACTORS. WITH REVIEW OF THE DEVICE HISTORY RECORDS AND REPORTED INFORMATION, THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES RELATED TO THE EVENT.
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IT WAS REPORTED THAT THERE WAS MIGRATION OF THE ENTERPRISE VRD (ENC452200/10212471) DURING AND AFTER (UNTIL 2 WEEKS AFTER) THE PROCEDURE FROM POSTERIOR CEREBRAL ARTERY INTO THE BASILAR ARTERY/CFR SUPRA. THE PHYSICIAN LEFT THE STENT IN PLACE AFTER THE MOVEMENT OF THE STENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 277418 | ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM | CNV ENTERPRISE SES (NJE) | NJE | CORDIS NEUROVASCULAR, INC. | 10212471 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Life Threatening |