ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
Report
- Report Number
- 1058196-2011-00218
- Event Type
- Death
- Date Received
- May 10, 2011
- Date of Event
- February 27, 2008
- Report Date
- April 11, 2011
- Manufacturer
- CORDIS NEUROVASCULAR, INC.
- Product Code
- NJE
- PMA / PMN Number
- H60001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
INFORMATION WAS RECEIVED POST UNEVENTFUL ENTERPRISE VRD ASSISTED COILING OF A LEFT MIDDLE CEREBRAL ARTERY ANEURYSM (MCA) THE PATIENT HAD SUBSEQUENT NEUROLOGICAL DECLINE SECONDARY TO A HEMORRHAGE. THE PATIENT'S CONDITION DID NOT RESPOND TO AGGRESSIVE INTERVENTIONS. CARE WAS WITHDRAWN AND THE PATIENT DIED TWO DAYS POST PROCEDURE. BASELINE ANGIOGRAPHY DEMONSTRATED A 3.5MM X 4MM ANEURYSM ON THE LEFT MCA M1 SEGMENT, PROXIMAL TO THE BIFURCATION, WHICH POINTED SUPERIORLY. THE NECK WAS BROAD MEASURING APPROXIMATELY 3 TO 3.5MM. NO OTHER ANEURYSMS OR INTRACRANIAL STENOSES WERE SEEN. A 6 FR ENVOY EX STRAIGHT GUIDECATHETER WAS INITIALLY DELIVERED INTO THE LEFT INTERNAL CAROTID ARTERY; HOWEVER, DUE TO UNSTABLE CATHETER POSITION AND EXCESSIVE EXCURSION, IT WAS EXCHANGED FOR A 6 FR. NEURON GUIDECATHETER. A 22MM ENTERPRISE VRD WAS DELIVERED THROUGH A PROWLER SELECT MICROCATHETER WHICH HAD BEEN PLACED INTO THE LEFT MCA SUPERIOR DIVISION. THE STENT WAS DEPLOYED WITH THE MIDDLE OF THE STENT OVERLAPPING THE ANEURYSM NECK. FOLLOWING RE-ADVANCEMENT OF THE PROWLER MICROCATHETER OVER THE STENT DELIVERY SYSTEM TO THE LEVEL OF THE ANEURYSM, THE PROWLER WAS EXCHANGED OVER AN EXCHANGE LENGTH MINIGUIDE WIRE FOR AN SL10 MICROCATHETER WHICH WAS ADVANCED INTO THE ANEURYSM. 3 EV3 COILS WERE DEPLOYED IN THE ANEURYSM. THE CONTROL ANGIOGRAPHY REVEALED THE COILS MASS TO BE WELL SEATED WITHIN THE ANEURYSM SAC AND THE PARENT VESSEL TO BE WIDELY PATENT PRIOR TO EACH COIL DETACHMENT. FINAL FOLLOW-UP CONTROL ANGIOGRAPHY POST EACH COIL DETACHMENT REVEALED THE PARENT VESSEL TO BE WIDELY PATENT WITH NO EVIDENCE OF BRANCH OCCLUSIONS. THE STENT REMAINED WIDELY PATENT WITH NO THROMBUS FORMATION OR EXTRAVASATION. NO FLOW WAS SEEN WITHIN THE ANEURYSM SAC. THE PATIENT WAS EXTUBATED, AWOKEN AND TRANSFERRED TO POST ANESTHESIA CARE UNIT AT BASELINE NEUROLOGICAL STATUS. IT WAS REPORTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO IMMEDIATE COMPLICATIONS. NO FURTHER INFORMATION IS AVAILABLE REGARDING THE PATIENT'S POST PROCEDURE NEUROLOGICAL OR THE REPORTED HEMORRHAGE. INTRACRANIAL HEMORRHAGE, VESSEL /ANEURYSM RUPTURE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM AND THE PROCEDURE AS OUTLINED IN THE INSTRUCTIONS FOR USE. THESE PROCEDURES ARE PERFORMED IN VESSELS WITH EXISTING ANEURYSMS AND KNOWN VESSEL WALL WEAKNESS. BASED ON THE LACK OF INFORMATION REGARDING THE REPORTED EVENT, NO CONCLUSION CAN BE MADE REGARDING THE RELATIONSHIP OF THE ENTERPRISE VRD AND THE REPORTED HEMORRHAGE AND SUBSEQUENT DEATH POST PROCEDURE. THE STENT REMAINS IMPLANTED AND THE LOT NUMBER IS NOT KNOWN; THEREFORE A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. WITH REVIEW OF THE AVAILABLE INFORMATION THERE IS NO INDICATION OF ANY DEVICE PERFORMANCE OR MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.
6FRENCH PINNACLE SHEATH, .038" TERUMO GLIDEWIRE, EV 3 (AXIUM 3D 3X80MM, AXIUM HELIX 2X60MM, AXIUM HELIX2X30MM) COILS, DAVIS CATHETER, PROWLER SELECT, STAR-CLOSE DEVICE MICROCATHETER, TRANSCEND EX .014: MICROGUIDEWIRE, AND SL 10 90 DEGREE MICROCATHETER. DURING THE PROCEDURE UTILIZING AN 18 GAUGE COOK NEEDLE A 6 FRENCH PINNACLE SHEATH WAS PLACED COAXIALLY INTO THE RIGHT COMMON FEMORAL ARTERY. RIGHT COMMON FEMORAL ARTERY ANGIOGRAPHY WAS PERFORMED WHICH REVEALED THE SHEATH TO BE ABOVE THE FEMORAL BIFURCATION, BELOW THE INGUINAL LIGAMENT AND THE VESSEL TO BE OF SUITABLE CALIBER FOR MECHANICAL CLOSURE. A 5 FRENCH DAVIS CATHETER WAS ADVANCED OVER A0.038 TERUMO GLIDEWIRE INTO THE AORTIC ARCH TO SELECT THE BRACHIOCEPHALIC ARTERY. THE CATHETER WAS CAREFULLY ADVANCED INTO THE RIGHT COMMON CAROTID ARTERY. ROAD-MAPPING PERFORMED OVER THE CAROTID BIFURCATION REVEALED THE BIFURCATION TO BE WIDELY PATENT AND THE VESSELS TO BE OF NORMAL CALIBER. THE ROAD-MAP WAS UTILIZED TO ADVANCE THE CATHETER INTO THE RIGHT INTERNAL CAROTID ARTERY. RIGHT INTERNAL CAROTID ARTERY ANGIOGRAPHY WAS PERFORMED IN THE AP, LATERAL AND OBLIQUE PROJECTIONS. ANGIOGRAPHY REVEALED BRISK ANTEGRADE OPACIFICATION OF THE RIGHT INTERNAL CAROTID ARTERY, RIGHT MIDDLE CEREBRAL ARTERY, RIGHT ANTERIOR CEREBRAL ARTERY WITH BRISK OPACIFICATION OF THE ANTERIOR COMMUNICATING ARTERY. NO ANEURYSMS, INTRACRANIAL STENOSIS, OR EARLY DRAINING VEINS ARE SEEN. THE VESSELS ARE OF NORMAL COURSE AND CALIBER AND TAPER REGULARLY. THE DURAL DEEP VENOUS SINUSES OPACIFY. THE CATHETER WAS WITHDRAWN INTO THE AORTIC ARCH. A ROAD-MAP REVEALED A BOVINE ORIGIN. THE CATHETER WAS CAREFULLY ADVANCED OVER AN LT GLIDEWIRE INTO THE LEFT INTERNAL CAROTID ARTERY. 20 HAND INJECTED CEREBRAL ANGIOGRAPHY WAS PERFORMED IN THE AP AND LATERAL PROJECTION. ANGIOGRAPHY REVEALED BRISK ANTEGRADE OPACIFICATION OF THE LEFT INTERNAL CAROTID ARTERY, LEFT MIDDLE CEREBRAL ARTERY, LEFT ANTERIOR CEREBRAL ARTERY AND THEIR BRANCHES. THERE IS A 3.5MM X 4MM ANEURYSM ON THE LEFT MIDDLE CEREBRAL ARTERY MI SEGMENT, PROXIMAL TO THE BIFURCATION, WHICH POINTS SUPERIORLY. THE NECK IS BROAD MEASURING APPROXIMATELY 3 TO 3.5MM. NO OTHER ANEURYSMS OR INTRACRANIAL STENOSES IS SEEN. THE DURAL DEEP VENOUS SINUSES OPACIFY NORMALLY. THE DAVIS CATHETER WAS EXCHANGED FOR A 6 FRENCH ENVOY XB STRAIGHT GUIDE CATHETER OVER AN EXCHANGE LENGTH GLIDEWIRE USING A ROAD-MAP. HOWEVER THE GUIDE CATHETER POSITION WAS UNSTABLE AND EXCESSIVE EXCURSION WAS NOTED. WE THOUGHT THIS WAS A PERILOUS SYSTEM AND THE 6 FRENCH ENVOY XB WAS CAREFULLY REMOVED AND EXCHANGED OVER GLIDEWIRE FOR A 6 FRENCH NEURON GUIDE CATHETER WHICH WAS POSITIONED IN THE LEFT INTERNAL CAROTID OPHTHALMIC SEGMENT. UTILIZING A ROAD-MAP A PROWLER SELECT MICROCATHETER WAS ADVANCED OVER A TRANSCEND EX PLATINUM 0.014 MICROGUIDEWIRE INTO THE LEFT MIDDLE CEREBRAL ARTERY SUPERIOR DIVISION. THE MICROGUIDEWIRE WAS REMOVED AND A CORDIS 4.5MM X 22CM ENTERPRISE STENT DELIVERY SYSTEM WAS ADVANCED INTO THE LEFT MIDDLE CEREBRAL ARTERY. THE STENT WAS CAREFULLY DEPLOYED WITH THE MIDDLE OF STENT OVERLAPPING THE ANEURYSM NECK. THE CATHETER WAS READVANCED OVER THE STENT DELIVERY SYSTEM TO LEVEL OF THE ANEURYSM AND THEN THE WIRE WAS REMOVED. THE PROWLER SELECT MICROCATHETER WAS EXCHANGED OVER A TRANSCEND EX EXCHANGE LENGTH MICROGUIDEWIRE FOR AN SL 10 90 DEGREE ANGLED MICROCATHETER. THE MICROCATHETER WAS CAREFULLY ADVANCED INTO THE LEFT MIDDLE CEREBRAL ARTERY ANEURYSM. A EV3 30 AXIURN 3MM X 8CM COIL WAS ADVANCED INTO THE ANEURYSM SAC AND DEPLOYED. FOLLOW UP INTERNAL ANGIOGRAPHY WAS PERFORMED WHICH REVEALED THE COIL MASS TO BE WELL SEATED WITHIN THE ANEURYSM SAC AND THE PARENT VESSEL TO BE WIDELY PATENT. THE COIL WAS DEPLOYED. THIS WAS FOLLOWED BY A EV3 AXIUM HELIX 2MM X 6CM COIL WHICH WAS ADVANCED INTO THE LEFT MIDDLE CEREBRAL ARTERY ANEURYSM AND DEPLOYED. FOLLOW UP INTERNAL ANGIOGRAPHY WAS PERFORMED WHICH REVEALED THE COIL MASS TO BE WELL SEATED WITHIN THE ANEURYSM SAC AND THE PARENT VESSEL TO BE WIDELY PATENT. THE COIL WAS DEPLOYED. A EV3 AXIUM HELIX 2MM X 3CM COIL WAS ADVANCED INTO THE ANEURYSM AND DEPLOYED. CONTROL ANGIOGRAPHY WAS PERFORMED WHICH REVEALED THE COIL MASS TO BE WELL SEATED WITHIN THE ANEURYSM SAC AND THE PARENT VESSEL TO BE WIDELY PATENT. THE COIL WAS DETACHED. THE MICROCATHETER WAS CAREFULLY REMOVED OVER THE GUIDEWIRE. FOLLOW UP CONTROL ANGIOGRAPHY WAS PERFORMED IN THE AP, LATERAL AND WORKING PROJECTION WHICH REVEALED THE PARENT VESSEL TO BE WIDELY PATENT WITH NO EVIDENCE OF BRANCH OCCLUSIONS. THE STENT REMAINS WIDELY PATENT WITH NO THROMBUS FORMATION OR EXTRAVASATION. NO FLOW IS SEEN WITHIN THE ANEURYSM SAC. THE CAPILLARY AND VENOUS PHASES REMAIN NORMAL. THE NEURON GUIDE CATHETER WAS CAREFULLY REMOVED FROM THE INTERNAL CAROTID ARTERY AND PATIENT. THE DAVIS 5 FRENCH CATHETER WAS ADVANCED OVER A 0.038 GLIDEWIRE INTO THE AORTIC ARCH AND SUBSEQUENTLY TO THE LEFT VERTEBRAL ARTERY. 2D HAND INJECTED CEREBRAL ANGIOGRAPHY WAS PERFORMED IN THE AP, LATERAL PROJECTIONS WHICH REVEALS BRISK ANTEGRADE OPACIFICATION OF THE LEFT VERTEBRAL ARTERY, LEFT POSTERIOR INFERIOR CEREBELLAR ARTERY, BASILAR ARTERY, BILATERAL ANTERIOR INFERIOR CEREBELLAR ARTERIES, BILATERAL SUPERIOR CEREBELLAR ARTERIES AND BILATERAL POSTERIOR CEREBRAL ARTERIES. RETROGRADE FLASH FILLING OF THE RIGHT VERTEBRAL ARTERY AND RIGHT POSTERIOR INFERIOR CEREBELLAR ARTERY IS ALSO DEMONSTRATED. NO ANEURYSMS, INTRACRANIAL STENOSIS, OR EARLY DRAINING VEINS IS SEEN. THE DURAL DEEP VENOUS SINUSES OPACIFY NORMALLY. AFTER REVIEW OF THE ANGIOGRAPHIC DATA, THE CATHETER WAS REMOVED. THE RIGHT COMMON FEMORAL ARTERY SHEATH WAS REMOVED AND HEMOSTASIS WAS ACHIEVED UTILIZING A STARCLOSE CLOSURE DEVICE. THE PATIENT WAS EXTUBATED ON THE TABLE, AWOKEN AND TRANSFERRED TO THE POST ANESTHESIA CARE UNIT AT HER BASELINE NEUROLOGICAL STATUS. THE PATIENT TOLERATED THE PROCEDURE WELL. THERE WERE NO IMMEDIATE COMPLICATIONS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
THE REPORT INDICATED OF THAT THE ENTERPRISE VRD WAS PLACED SUCCESSFULLY AT THE NECK OF THE LEFT MIDDLE CEREBRAL ARTERY AND THEN THE ANEURYSM WAS OBLITERATED WITH EV3 COILS. ADDITIONALLY, DURING REVIEW OF THE INFORMATION, IT WAS NOTED THERE WAS POSITIONING DIFFICULTY WITH A 6FRENCH ENVOY XB STRAIGHT THAT WAS REMOVED VIA A GUIDEWIRE AND ANOTHER NON-CORDIS/CODMAN GUIDING CATHETER WAS UTILIZED. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT HAD NEUROLOGICAL DECLINED SECONDARY TO A HEMORRHAGE, AND SUBSEQUENTLY DETERIORATED TO A DEVASTATING NEUROLOGICAL EXAM AND DID NOT RESPOND TO AGGRESSIVE INTERVENTIONS. GIVEN THE POOR CONDITION AND PROGNOSIS, THE FAMILY ELECTED O WITHDRAW CARE AND THE PATIENT EXPIRED TWO DAYS AFTER THE PROCEDURE. THE SITE INDICATED THAT THE DEATH WAS UNRELATED TO THE DEVICE AND PROCEDURE
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM | CNV ENTERPRISE SES (NJE) | NJE | CORDIS NEUROVASCULAR, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Death |