ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
Report
- Report Number
- 1058196-2011-00219
- Event Type
- Death
- Date Received
- May 10, 2011
- Date of Event
- April 10, 2009
- Report Date
- April 11, 2011
- Manufacturer
- CORDIS NEUROVASCULAR, INC.
- Product Code
- NJE
- PMA / PMN Number
- H60001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
THE COMPLAINT RECEIVED STATES THAT DURING A CEREBRAL INTERVENTIONAL PROCEDURE THE ENTERPRISE STENT HAD INCOMPLETE EXPANSION AND THAT THE PATIENT HAD DIED. THE REPORT INDICATED THE OFF-LABEL USE OF THE ENTERPRISE VRD SYSTEM FOR SUCCESSFUL REVASCULARIZATION OF AN OCCLUDED LEFT CAVERNOUS CAROTID WITH BALLOON MACERATION, ANGIOPLASTY AND STENTING OF A DISSECTED VERTEBRAL ARTERY. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT EXPIRED, BUT THE CAUSE IS UNKNOWN AND WAS NOT RELATED TO THE DEVICE. THE INTENDED PROCEDURE WAS BALLOON MACERATION AND ANGIOPLASTY OF ORGANIZED THROMBUS AND UNDERLYING STENOSIS IN THE OPHTHALMIC AND ANTERIOR GENU OF THE CAVERNOUS CAROTID. A 3.0X12MM A MAVERICK BALLOON WAS ADVANCED INTO THE ANTERIOR GENU OF THE CAVERNOUS CAROTID UTILIZING A ROAD MAP AND INFLATED. FOLLOW-UP CONTROL ANGIOGRAPHY WITH LEFT INTERNAL CAROTID ARTERY INJECTION WAS PERFORMED WHICH REVEALED ANTEGRADE OPACIFICATION OF THE INTRACRANIAL LEFT INTERNAL CAROTID ARTERY, LEFT MIDDLE CEREBRAL ARTERY, LEFT ANTERIOR CEREBRAL ARTERY AND THEIR BRANCHES. NO DISTAL BRANCH OCCLUSIONS ARE SEEN. THE CAVERNOUS SEGMENT AND PROXIMAL OPHTHALMIC SEGMENTS DEMONSTRATES A FLOW LIMITING DISSECTION WITH A RAISED DISSECTION FLAP. THEN A 4.5X 22MM CORDIS ENTERPRISE VASCULAR RECONSTRUCTION DEVICE WAS ADVANCED THROUGH THE PROWLER MICROCATHETER AND DEPLOYED ACROSS THE OPHTHALMIC AND CAVERNOUS SEGMENTS AND THE DISSECTED SECTION. FOLLOW-UP CONTROL ANGIOGRAPHY WAS PERFORMED WHICH DEMONSTRATED THE STENT TO BE WELL POSITIONED ACROSS THE DISSECTION FLAP WITH GOOD DISTAL ANTEGRADE FILLING OF THE LEFT MIDDLE AND ANTERIOR CEREBRAL ARTERIES AND THEIR BRANCHES. HOWEVER, THE DISSECTION FLAP WAS STILL EVIDENT WITH SLIGHT STAGNATION OF CONTRAST UNDER THE FLAP. ADDITIONALLY, THERE APPEARS TO BE SLIGHT OVALIZATION OF THE STENT BETWEEN THE STENT TINES. THE STENT DELIVERY SYSTEM WAS REMOVED. A NEW MAVERICK 3.5 MM BY 15 MM BALLOON WAS ADVANCED OVER A 0.014 TRANSCEND GUIDEWIRE INTO THE LEFT INTERNAL CAROTID ARTERY AND INTO THE PROXIMAL PORTION OF THE CAVERNOUS STENT. ANGIOPLASTY WAS PERFORMED TO TACK DOWN THE DISSECTION FLAP BY POST DILATION OF THE STENT. THE BALLOON WAS REMOVED. FINAL FOLLOW-UP CONTROL ANGIOGRAMS WERE PERFORMED IN THE WORKING, AP AND LATERAL PROJECTIONS WHICH DEMONSTRATED GOOD OPPOSITION OF THE STENT TO THE VESSEL WALL WITH NO RESIDUAL DISSECTION FLAP SEEN. THERE IS GOOD ANTEGRADE FILLING LEFT INTERNAL CAROTID ARTERY, MIDDLE AND ANTERIOR CEREBRAL ARTERIES AND THEIR BRANCHES. NO DISTAL BRANCH OCCLUSIONS ARE SEEN. HEMOSTASIS WAS ACHIEVED UTILIZING A STARCLOSE DEVICE. THE PATIENT WAS EXTUBATED ON THE TABLE, AWOKEN AND TRANSFERRED TO THE PACU AT THEIR BASELINE NEUROLOGICAL STATUS. TO DATE NO FURTHER INFORMATION HAS BEEN AVAILABLE REGARDING THE DETAILS OF THE PATIENT'S DEATH. THE PRODUCT WAS NOT RETURNED SO NO DETAILED INVESTIGATION WAS POSSIBLE AND THERE IS NO STERILE LOT NUMBER INFORMATION AVAILABLE THUS NO DHR COULD BE PERFORMED. THE COMPLAINT OF STENT INCOMPLETE EXPANSION COULD NOT BE CONFIRMED WITHOUT THE RETURN OF THE PRODUCT OR INTERVENTIONAL FILMS FOR REVIEW. THERE IS NO STERILE LOT NUMBER INFORMATION AVAILABLE SO NO DHR COULD BE REVIEWED. REVIEW OF THE INFORMATION SUGGESTS THAT VESSEL AND LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. IT IS A COMMON OCCURRENCE FOR PRACTITIONERS TO CHOOSE TO POST DILATE STENTS, AS THE CONDITIONS INSIDE OF THE TARGET LESION OFTEN PREVENT COMPLETE EXPANSION OF THE DEVICES DURING THE INITIAL DEPLOYMENT PHASE. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. DEATH IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE AND IS LISTED IN THE IFU (INSTRUCTIONS FOR USE) AS SUCH. THERE IS NO EVIDENCE TO SUGGEST THERE WERE ANY MANUFACTURING ISSUES THAT CONTRIBUTED TO THE REPORTED EVENT. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE AVAILABLE INFORMATION DOES NOT ALLOW FOR AN EXACT DETERMINATION OF CAUSAL FACTORS; HOWEVER, THE PATIENT HAD AN INTRACRANIAL ARTERIAL STENOSIS AND A PROCEDURAL RELATED VESSEL DISSECTION THAT MAY HAVE CONTRIBUTED TO THE REPORTED DEATH.
PRIOR TO THE STENT, A 3.0X12MM A MAVERICK BALLOON THAT WAS ADVANCED INTO THE ANTERIOR GENU OF THE CAVERNOUS CAROTID UTILIZING A ROAD MAP. BALLOON MACERATION AND ANGIOPLASTY OF ORGANIZED THROMBUS AND UNDERLYING STENOSIS WAS PERFORMED ALONG THE OPHTHALMIC AND ANTERIOR GENU OF THE CAVERNOUS CAROTID. FOLLOW-UP CONTROL ANGIOGRAPHY WITH LEFT INTERNAL CAROTID ARTERY INJECTION WAS PERFORMED WHICH REVEALED ANTEGRADE OPACIFICATION OF THE INTRACRANIAL LEFT INTERNAL CAROTID ARTERY, LEFT MIDDLE CEREBRAL ARTERY, LEFT ANTERIOR CEREBRAL ARTERY AND THEIR BRANCHES. NO DISTAL BRANCH OCCLUSIONS ARE SEEN. THE CAVERNOUS SEGMENT AND PROXIMAL OPHTHALMIC SEGMENTS DEMONSTRATES A FLOW LIMITING DISSECTION WITH A RAISED DISSECTION FLAP. 5FRENCH SIMMONS II CATHETER, .038" TERUMO GLIDEWIRE, 6FRENCH .053" NEURON GUIDE CATHETER, PROWLER SELECT PLUS MICROCATHETER, TRANSCEND EX .014" GUIDEWIRE, MAVERICK 3X12MM BALLOON, MAVERICK 3.5X15MM BALLOON, AND A STAR-CLOSE DEVICE. UTILIZING AN 18G COOK NEEDLE A 6 FRENCH PINNACLE SHEATH WAS PLACED INTO THE RIGHT COMMON FEMORAL ARTERY. RIGHT COMMON FEMORAL ARTERIOGRAPHY WAS PERFORMED WHICH REVEALS THE FEMORAL SHEATH TO BE ABOVE THE FEMORAL BIFURCATION, BELOW THE INGUINAL LIGAMENT AND THE VESSEL TO BE OF SUITABLE CALIBER FOR MECHANICAL CLOSURE. 5000 UNITS OF INTRAVENOUS HEPARIN AND INTERMITTENT BOLUSES WERE ADMINISTERED TO MAINTAIN AN ACT 2 - 2.5 TIMES THE PATIENT'S BASELINE. THE LEFT COMMON CAROTID ARTERY WAS ACCESS WITH A 5FRENCH SIMMONS II CATHETER WAS ADVANCED INTO THE AORTIC ARCH OVER A 0.038 TERUMO GLIDEWIRE, REFORMATTED AND ADVANCED INTO THE LEFT COMMON CAROTID ARTERY. 20 HAND INJECTED ANGIOGRAPHY WAS PERFORMED CENTERED AT THE BIFURCATION WHICH AS AT THE C3/C4 LEVEL. MILD SOFT PLAQUING OF THE CURRENT BIFURCATION IS PRESENT. THERE IS SIGNIFICANTLY DELAYED FILLING OF THE CERVICAL LEFT INTERNAL CAROTID ARTERY SECONDARY TO A DISTAL OCCLUSION. THE LEFT EXTERNAL CAROTID ARTERY BRANCHES OPACIFY AND RECONSTITUTE THE LEFT OPHTHALMIC ARTERY VIA SPHENOPALATINE COLLATERALS. THE OPHTHALMIC ARTERY FILLS IN A RETROGRADE FASHION WITH OPACIFICATION OF THE OPHTHALMIC AND SUPRACLINOID LEFT INTERNAL CAROTID ARTERY WITH ANTEGRADE OPACIFICATION OF THE LEFT MIDDLE CEREBRAL ARTERY AND ITS BRANCHES. THE CERVICAL LEFT INTERNAL CAROTID ARTERY FILLS IN A SIGNIFICANTLY DELAYED FASHION WITH DELAYED OPACIFICATION OF THE PETROUS AND PROXIMAL CAVERNOUS SEGMENTS. THERE IS A SMALL FOCAL OCCLUSION BETWEEN THE OPHTHALMIC ARTERY AND THE ANTERIOR GENU OF THE CAVERNOUS CAROTID. UTILIZING A ROAD MAP, THE SIMMONS II CATHETER WAS EXCHANGED FOR A 6 FR. 0.53 NEURON GUIDE CATHETER OVER AN EXCHANGE LENGTH 0.038 GLIDEWIRE AND POSITIONED IN THE PETROUS LEFT INTERNAL CAROTID ARTERY. THE LEFT INTERNAL CAROTID ARTERY ANGIOPLASTY AND STENTING: UTILIZING A ROAD MAP, A PROWLER SELECT MICROCATHETER WAS ADVANCED OVER A 0.014 TRANSCEND EX PLATINUM GUIDEWIRE INTO THE CAVERNOUS CAROTID. THE CATHETER AND WAS GUIDEWIRE WERE ADVANCED BEYOND THE CAVERNOUS SEGMENT OCCLUSION INTO THE LEFT MIDDLE CEREBRAL ARTERY. SELECTIVE LEFT MIDDLE CEREBRAL ARTERY ANGIOGRAPHY WAS PERFORMED WHICH DEMONSTRATED OPACIFICATION OF THE LEFT MIDDLE CEREBRAL ARTERY AND DISTAL BRANCHES WITH NO BRANCH OCCLUSIONS. THE PROWLER SELECT MICROCATHETER WAS EXCHANGED OVER A 0.014 TRANSCEND FLOPPY EXCHANGE GUIDEWIRE FOR A 3.0 X 12 MM MAVERICK BALLOON WHICH WAS ADVANCED INTO THE ANTERIOR GENU OF THE CAVERNOUS CAROTID UTILIZING A ROAD MAP. BALLOON MACERATION AND ANGIOPLASTY OF ORGANIZED THROMBUS AND UNDERLYING STENOSIS WAS PERFORMED ALONG THE OPHTHALMIC AND ANTERIOR GENU OF THE CAVERNOUS CAROTID. FOLLOW-UP CONTROL ANGIOGRAPHY WITH LEFT INTERNAL CAROTID ARTERY INJECTION WAS PERFORMED WHICH REVEALED ANTEGRADE OPACIFICATION OF THE INTRACRANIAL LEFT INTERNAL CAROTID ARTERY, LEFT MIDDLE CEREBRAL ARTERY, LEFT ANTERIOR CEREBRAL ARTERY AND THEIR BRANCHES. NO DISTAL BRANCH OCCLUSIONS ARE SEEN. THE CAVERNOUS SEGMENT AND PROXIMAL OPHTHALMIC SEGMENTS DEMONSTRATES A FLOW LIMITING DISSECTION WITH A RAISED DISSECTION FLAP. THE MAVERICK BALLOON WAS EXCHANGED FOR THE PROWLER SELECT MICROCATHETER. A 4.5 MM X 22 MRN CORDIS ENTERPRISE VASCULAR RECONSTRUCTION DEVICE WAS ADVANCED THROUGH THE PROWLER MICROCATHETER AND DEPLOYED ACROSS THE OPHTHALMIC AND CAVERNOUS SEGMENTS. FOLLOW-UP CONTROL ANGIOGRAPHY WAS PERFORMED WHICH DEMONSTRATED THE STENT TO BE WELL POSITIONED ACROSS THE DISSECTION FLAP WITH GOOD DISTAL ANTEGRADE FILLING OF THE LEFT MIDDLE AND ANTERIOR CEREBRAL ARTERIES AND THEIR BRANCHES. THE DISSECTION FLAP IS STILL EVIDENT WITH SLIGHT STAGNATION OF CONTRAST UNDER THE FLAP. ADDITIONALLY, THERE APPEARS TO BE SLIGHT OVALIZATION OF THE STENT BETWEEN THE STENT TINES. THE STENT DELIVERY SYSTEM WAS REMOVED. A NEW MAVERICK 3.5 MM BY 15 MM BALLOON WAS ADVANCED OVER A 0.014 TRANSCEND GUIDEWIRE INTO THE LEFT INTERNAL CAROTID ARTERY AND INTO THE PROXIMAL PORTION OF THE CAVERNOUS STENT. ANGIOPLASTY WAS PERFORMED TO TACK DOWN THE STENT AND DISSECTION FLAP. THE BALLOON WAS REMOVED. FINAL FOLLOW-UP CONTROL ANGIOGRAMS WERE PERFORMED IN THE WORKING, AP AND LATERAL PROJECTIONS WHICH DEMONSTRATED GOOD OPPOSITION OF THE STENT TO THE VESSEL WALL WITH NO RESIDUAL DISSECTION FLAP SEEN. THERE IS GOOD ANTEGRADE FILLING LEFT INTERNAL CAROTID ARTERY, MIDDLE AND ANTERIOR CEREBRAL ARTERIES AND THEIR BRANCHES. NO DISTAL BRANCH OCCLUSIONS ARE SEEN. AFTER REVIEW OF THE ANGIOGRAPHIC DATA THE NEURON GUIDE CATHETER WAS REMOVED. THE RIGHT COMMON FEMORAL ARTERY SHEATH WAS REMOVED. HEMOSTASIS WAS ACHIEVED UTILIZING A STARCLOSE DEVICE. THE PATIENT WAS EXTUBATED ON THE TABLE, AWOKEN AND TRANSFERRED TO THE PACU AT THEIR BASELINE NEUROLOGICAL STATUS. THERE WERE NO IMMEDIATE COMPLICATIONS. COMPLICATIONS CONSISTED OF FLOW LIMITING DISSECTION OF THE LEFT CAVERNOUS CAROTID FOLLOWING BALLOON MACERATION AND ANGIOPLASTY OF CLOT AND UNDERLYING STENOSIS, SUCCESSFULLY TREATED WITH STENTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
THE REPORT INDICATED THE OFF-LABEL USE OF THE ENTERPRISE VRD SYSTEM FOR SUCCESSFUL REVASCULARIZATION OF AN OCCLUDED LEFT CAVERNOUS CAROTID WITH BALLOON MACERATION, ANGIOPLASTY AND STENTING OF A DISSECTED VERTEBRAL ARTERY. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT EXPIRED, BUT THE CAUSE IS UNKNOWN AND WAS NOT RELATED TO THE DEVICE. DURING THE PROCEDURE, A 4.5X 22MM CORDIS ENTERPRISE VASCULAR RECONSTRUCTION DEVICE WAS ADVANCED THROUGH THE PROWLER MICROCATHETER AND DEPLOYED ACROSS THE OPHTHALMIC AND CAVERNOUS SEGMENTS AND INTO THE DISSECTED VESSEL THAT WAS ANGIOPLASTY WITH A NON-CORDIS BALLOON. FOLLOW-UP CONTROL ANGIOGRAPHY WAS PERFORMED WHICH DEMONSTRATED THE STENT TO BE WELL POSITIONED ACROSS THE DISSECTION FLAP WITH GOOD DISTAL ANTEGRADE FILLING OF THE LEFT MIDDLE AND ANTERIOR CEREBRAL ARTERIES AND THEIR BRANCHES. THE DISSECTION FLAP IS STILL EVIDENT WITH SLIGHT STAGNATION OF CONTRAST UNDER THE FLAP. ADDITIONALLY, THERE APPEARS TO BE SLIGHT OVALIZATION OF THE STENT BETWEEN THE STENT TINES. THE STENT DELIVERY SYSTEM WAS REMOVED. A NEW MAVERICK 3.5 MM BY 15 MM BALLOON WAS ADVANCED OVER A 0.014 TRANSCEND GUIDEWIRE INTO THE LEFT INTERNAL CAROTID ARTERY AND INTO THE PROXIMAL PORTION OF THE CAVERNOUS STENT. ANGIOPLASTY WAS PERFORMED TO TACKED DOWN THE STENT AND DISSECTION FLAP. THE BALLOON WAS REMOVED. FINAL FOLLOW-UP CONTROL ANGIOGRAMS WERE PERFORMED IN THE WORKING, AP AND LATERAL PROJECTIONS WHICH DEMONSTRATED GOOD OPPOSITION OF THE STENT TO THE VESSEL WALL WITH NO RESIDUAL DISSECTION FLAP SEEN. THERE IS GOOD ANTEGRADE FILLING LEFT INTERNAL CAROTID ARTERY, MIDDLE AND ANTERIOR CEREBRAL ARTERIES AND THEIR BRANCHES. NO DISTAL BRANCH OCCLUSIONS ARE SEEN.
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 | Death| R |