ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
Report
- Report Number
- 1058196-2011-00302
- Event Type
- Injury
- Date Received
- June 20, 2011
- Date of Event
- February 28, 2011
- Report Date
- May 23, 2011
- Manufacturer
- CORDIS NEUROVASCULAR, INC.
- Product Code
- NJE
- PMA / PMN Number
- H60001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
THE COMPLAINT RECEIVED STATES THAT DURING THE INDEX PROCEDURE FOR THIS (B)(4) STUDY PATIENT THE ENTERPRISE STENT HAD INACCURATE PLACEMENT AND THEN POST PROCEDURE THE PATIENT SUFFERED A HEMORRHAGIC STROKE TWO DAYS POST PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT APPROXIMATELY ONE MONTH POST PROCEDURE MRI REVEALED OCCLUSION OF THE PARENT VESSEL. THE LOCATION OF THE OCCLUSION AS RELATED TO THE ENTERPRISE VRD IS NOT KNOWN. IT WAS REPORTED THAT THE PATIENT WAS NOT COMPLIANT WITH MEDICAL THERAPY. NO ACTION WAS TAKEN WITH FOLLOW-UP ANGIOGRAPHY FIVE MONTHS LATER CONFIRMING THAT THE PARENT VESSEL WAS PATENT. THE INDEX PROCEDURE WAS COIL EMBOLIZATION ASSISTED WITH THE ENTERPRISE VRD (B)(4) STENT OF AN ANEURYSM IN THE BASILAR ARTERY. THE ENTERPRISE WAS ADVANCED TOO MUCH THAT THE STENT WAS DEPLOYED IN THE DISTAL VESSEL, BUT EVENTUALLY WAS PLACED IN THE CORRECT POSITION, AND THE COIL EMBOLIZATION WAS COMPLETED SUCCESSFULLY. HOWEVER, 2 DAYS AFTER THE PROCEDURE, THE PATIENT DEVELOPED STOKE (BLEEDING OF BRAIN STEM AROUND THE ANEURYSM) AND BRAIN EDEMA. HOWEVER, THE BLEEDING WAS NEITHER FROM THE ANEURYSM OR THE PARENT VESSEL, BUT THERE WAS NO INFORMATION EXACTLY WHERE THE BLEEDING OCCURRED. THE SYMPTOMS WERE HEMIPLEGIA (RIGHT SIDE), MILD DISORDER OF EYE MOVEMENT (BOTH SIDES), NUMBNESS OF RIGHT SIDE BODY, AND TRUNCAL ATAXIA. STEROID DRUG THERAPY WAS DONE BUT RECOVERY WAS NOT CONFIRMED AS OF A MONTH AFTER ONSET OF SYMPTOMS. THE STENT WAS PATENT DURING THE EVENT, AND NO COIL WAS PROTRUDING INTO THE PARENT ARTERY. THE ENTERPRISE WAS FULLY EXPANDED AND APPOSE TO THE VESSEL WALL AFTER INITIAL PLACEMENT, AND THE ENTERPRISE WAS FULLY EXPANDED, APPOSE TO THE VESSEL WALL AND IN A STABLE POSITION AS COMPARED TO POSITION AFTER PLACEMENT. ANGIOGRAMS DURING THE PROCEDURE DID NOT SHOW ANY SIGNS OF PERFORATION OR EXTRAVASATION OF THE VESSEL, AND THE ANEURYSM DID NOT RUPTURE. DURING THE PROCEDURE, THE ANEURYSM WAS COMPLETELY OBLITERATED. THE MODIFIED (B)(6) SCALE PRE-PROCEDURE WAS 0, AFTER AND WITHIN A WEEK WAS 4, AND AFTER 30 DAYS IT WAS 4, AND THE ACT PRE-PROCEDURE WAS 130 SECONDS AND AFTER THE PROCEDURE WAS 285 SECONDS. THERE WERE NO INDICATIONS OF ANY CONDITIONS CAUSING HYPERCOAGULABLE STATE. THE EVENT WITH THE ENTERPRISE STENT OCCURRED WHEN THE STENT WAS DEPLOYED. THE STENT WAS DEPLOYED SLIGHTLY DISTAL TO THE INTENDED TARGET LESION. THE DEPLOYED STENT WAS PULLED BACK WITH THE GUIDEWIRE (ALREADY PLACED IN THE TARGET SITE FOR THE JAILED TECHNIQUE) SLIGHTLY, AND WAS PLACED IN THE CORRECT POSITION EVENTUALLY. THE PHYSICIAN COMMENTED HE MIGHT HAVE MISJUDGED THE DELIVERY WIRE LENGTH. ALL LABELING INSTRUCTIONS WERE FOLLOWED FOR DEPLOYMENT WITH THE PROWLER SELECT PLUS MICROCATHETER ((B)(4)/LOT 15196926). THE ANTIPLATELET THERAPY CONSISTED OF ASPIRIN 100MG/DAY ((B)(6) 2011- ) AND PLAVIX 75MG/DAY ((B)(6) 2011-). THE UNRUPTURED ANEURYSM NECK MEASURE 7.0MM AND THE NECK TO SAC RATIO WAS 7.0MM/ 15.0MM, AND THE PARENT VESSEL SIZE/DIAMETER PROXIMALLY WAS 3.0MM AND DISTALLY WAS 2.8MM. A CD COPY OF THE PROCEDURE IS NOT AVAILABLE. NO FURTHER INFORMATION WAS AVAILABLE. THE STENT REMAINS IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01425605. 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. HEMORRHAGE, STROKE AND NEUROLOGIC DEFICITS ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF INTRACRANIAL STENT PLACEMENT AND ARE LISTED IN THE ENTERPRISE IFU AS SUCH. THE INHERENT RISK OF INTRODUCING DEVICES INTO THE DELICATE CEREBRAL VESSELS AS WELL AS THE CHANGES IN INTRACRANIAL PRESSURES AND ANATOMY POST COIL PLACEMENT WITHIN THE ANEURYSM CAN CONTRIBUTE TO THE OCCURRENCE OF INTRACRANIAL AND ANEURISMAL BLEEDING COMPLICATIONS. COIL EMBOLIZATION PATIENTS ARE STARTED AND MAINTAINED ON ANTICOAGULANT AND ANTI-PLATELET MEDICATION REGIMENS THAT CAN CONTRIBUTE TO THE LIKELY HOOD OF BLEEDING IN THE PERI AND POST OPERATIVE PHASES. ADDITIONALLY, AS OUTLINED IN THE INSTRUCTIONS FOR USE, OCCLUSION OF THE TREATED SITE IS A KNOWN POTENTIAL ADVERSE EVENT. IT WAS REPORTED THAT THE PATIENT WAS NOT COMPLIANT WITH THE POST PROCEDURE ANTIPLATELET THERAPY, WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE INFORMATION SUGGESTS THAT TARGET LESION, SPECIFICALLY THE SIZE OF THE ANEURYSM AND THE NUMBER OF COILS INSERTED, MEDICATION REGIMEN AND PROCEDURAL ISSUES MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.
ADDITIONAL INFORMATION INDICATED THAT A MRI REVEALED THE PARENT VESSEL OCCLUSION APPROXIMATELY A MONTH AFTER THE INDEX PROCEDURE, BUT NO ACTION WAS TAKEN. INFORMATION ALSO INDICATED THAT THE PATIENT WAS NOT COMPLIANT WITH MEDICAL THERAPY. A FOLLOW UP ANGIOGRAPHY PERFORMED FIVE MONTHS AFTER THE EVENT CONFIRMED THAT THE PARENT VESSEL WAS PATENT. THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS UNKNOWN, AND TO THE DEVICE ALSO UNKNOWN. THERE IS NO MORE INFORMATION AVAILABLE REGARDING THIS EVENT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
THE COMPLAINT RECEIVED STATES THAT DURING THE INDEX PROCEDURE FOR THIS (B)(6) PATIENT THE ENTERPRISE STENT HAD INACCURATE PLACEMENT AND THEN POST PROCEDURE SUFFERED A HEMORRHAGIC STROKE. THE REPORT FROM A CLINICAL STUDY (B)(6) FOR PATIENT WITH (B)(6) INDICATED THAT THE PROCEDURE WAS COIL EMBOLIZATION ASSISTED WITH THE ENTERPRISE VRD (B)(4) STENT OF AN ANEURYSM IN THE BASILAR ARTERY, AND THE ENTERPRISE WAS ADVANCED TOO MUCH THAT THE STENT WAS DEPLOYED IN THE DISTAL VESSEL, BUT EVENTUALLY WAS PLACED IN THE CORRECT POSITION, AND THE COIL EMBOLIZATION WAS COMPLETED SUCCESSFULLY. HOWEVER, 2 DAYS AFTER THE PROCEDURE, THE PATIENT DEVELOPED STOKE (BLEEDING OF BRAIN STEM AROUND THE ANEURYSM) AND BRAIN EDEMA. HOWEVER, THE BLEEDING WAS NEITHER FROM THE ANEURYSM OR THE PARENT VESSEL, BUT THERE WAS NO INFORMATION EXACTLY WHERE THE BLEEDING OCCURRED. THE SYMPTOMS WERE HEMIPLEGIA (RIGHT SIDE), MILD DISORDER OF EYE MOVEMENT (BOTH SIDES), NUMBNESS OF RIGHT SIDE BODY, AND TRUNCAL ATAXIA. STEROID DRUG THERAPY WAS DONE BUT RECOVERY WAS NOT CONFIRMED AS OF A MONTH AFTER ONSET OF SYMPTOMS. THE STENT WAS PATENT DURING THE EVENT, AND NO COIL WAS PROTRUDING INTO THE PARENT ARTERY. THE ENTERPRISE WAS FULLY EXPANDED AND APPOSE TO THE VESSEL WALL AFTER INITIAL PLACEMENT, AND THE ENTERPRISE WAS FULLY EXPANDED, APPOSE TO THE VESSEL WALL AND IN A STABLE POSITION AS COMPARED TO POSITION AFTER PLACEMENT. ANGIOGRAMS DURING THE PROCEDURE DID NOT SHOW ANY SIGNS OF PERFORATION OR EXTRAVASATION OF THE VESSEL, AND THE ANEURYSM DID NOT RUPTURED. DURING THE PROCEDURE, THE ANEURYSM WAS COMPLETELY OBLITERATED. THE MODIFIED RANKIN SCALE PRE-PROCEDURE WAS 0, AFTER AND WITHIN A WEEK WAS 4, AND AFTER 30 DAYS IT WAS 4, AND THE ACT PRE-PROCEDURE WAS 130 SECONDS AND AFTER THE PROCEDURE WAS 285 SECONDS. THERE WERE NO INDICATIONS OF ANY CONDITIONS CAUSING HYPERCOAGULABLE STATE. THE EVENT WITH THE ENTERPRISE STENT OCCURRED WHEN THE STENT WAS DEPLOYED. THE STENT WAS DEPLOYED SLIGHTLY DISTAL TO THE INTENDED TARGET LESION. THE DEPLOYED STENT WAS PULLED BACK WITH THE GUIDEWIRE (ALREADY PLACED IN THE TARGET SITE FOR THE JAILED TECHNIQUE) SLIGHTLY, AND WAS PLACED IN THE CORRECT POSITION EVENTUALLY. THE PHYSICIAN COMMENTED HE MIGHT MISJUDGE THE DELIVERY WIRE LENGTH. ALL LABELING INSTRUCTIONS WERE FOLLOWED FOR DEPLOYMENT WITH THE PROWLER SELECT PLUS MICROCATHETER ((B)(4)/LOT 15196926). OTHER PRODUCTS USED DURING THE PROCEDURE CONSISTED OF ECHELON 14 MC, ROAD MASTER 7FRENCH GUIDING CATHETER, SILVER SPEED GUIDEWIRE, 40 ORBIT COILS ((B)(4)/LOT 15137037, (B)(4)/LOT 15159096, (B)(4)/LOT 15159096, (B)(4)/LOT 15158719 X2, (B)(4)/LOT 15147547, (B)(4)/LOT 15161042, (B)(4)/(LOT 15172921, GALAXY (B)(4)/LOT 15122082, (B)(4)/LOT 15141593 X2, (B)(4)/LOT 15169078 X2, (B)(4)/LOT 15182283, (B)(4)/LOT 15178883, (B)(4)/LOT 15182283 X3, (B)(4)/LOT 15174573 X2, GALAXY LOT: 13500204 X5, (B)(4)/LOT 15174573, (B)(4)/LOT 15140373, (B)(4)/LOT 15181125, (B)(4)/LOT 15182282 X3, (B)(4)/LOT 15111896 X2, (B)(4)/LOT 15181125, (B)(4)/LOT 15141582, (B)(4)/LOT 15178883, (B)(4)/LOT 16126487, GDC (QTY 3), ED (QTY 2), AND PRESIDIO (QTY 2). THE ANTIPLATELET THERAPY CONSISTED OF ASPIRIN 100MG/DAY ((B)(6) 2011- ) AND PLAVIX 75MG/DAY ((B)(6) 2011-). THE UNRUPTURED ANEURYSM NECK MEASURE 7.0MM AND THE NECK TO SAC RATIO WAS 7.0MM/ 15.0MM, AND THE PARENT VESSEL SIZE/DIAMETER PROXIMALLY WAS 3.0MM AND DISTALLY WAS 2.8MM. A CD COPY OF THE PROCEDURE IS NOT AVAILABLE. NO FURTHER INFORMATION WAS AVAILABLE. THE STENT REMAINS IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. LR PACKAGING L/N # (B)(4). PER LAKE REGION REPORT (B)(4): LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01425605. 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. HEMORRHAGE, STROKE AND NEUROLOGIC DEFICITS ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF INTRACRANIAL STENT PLACEMENT AND ARE LISTED IN THE ENTERPRISE IFU AS SUCH. THE INHERENT RISK OF INTRODUCING DEVICES INTO THE DELICATE CEREBRAL VESSELS AS WELL AS THE CHANGES IN INTRACRANIAL PRESSURES AND ANATOMY POST COIL PLACEMENT WITHIN THE ANEURYSM CAN CONTRIBUTE TO THE OCCURRENCE OF INTRACRANIAL AND ANEURISMAL BLEEDING COMPLICATIONS. COIL EMBOLIZATION PATIENTS ARE STARTED AND MAINTAINED ON ANTICOAGULANT AND ANTI-PLATELET MEDICATION REGIMENS THAT CAN CONTRIBUTE TO THE LIKELY HOOD OF BLEEDING IN THE PERI AND POST OPERATIVE PHASES. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE INFORMATION SUGGESTS THAT TARGET LESION, SPECIFICALLY THE SIZE OF THE ANEURYSM AND THE NUMBER OF COILS INSERTED, MEDICATION REGIMEN AND PROCEDURAL ISSUES MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.
THE ENTERPRISE WAS FULLY EXPANDED AND APPOSED TO THE VESSEL WALL AFTER INITIAL PLACEMENT, AND THE ENTERPRISE WAS FULLY EXPANDED, APPOSED TO THE VESSEL WALL AND IN A STABLE POSITION AS COMPARED TO POSITION AFTER PLACEMENT. ANGIOGRAMS DURING THE PROCEDURE DID NOT SHOW ANY SIGNS OF PERFORATION OR EXTRAVASATION OF THE VESSEL, AND THE ANEURYSM DID NOT RUPTURED. DURING THE PROCEDURE, THE ANEURYSM WAS COMPLETELY OBLITERATED. THERE WERE NO INDICATIONS OF ANY CONDITIONS CAUSING HYPERCOAGULABLE STATE. THE EVENT WITH THE ENTERPRISE STENT OCCURRED WHEN THE STENT WAS DEPLOYED. THE STENT WAS DEPLOYED SLIGHTLY DISTAL TO THE INTENDED TARGET LESION. THE DEPLOYED STENT WAS PULLED BACK WITH THE GUIDEWIRE (ALREADY PLACED IN THE TARGET SITE FOR THE JAILED TECHNIQUE) SLIGHTLY, AND WAS PLACED IN THE CORRECT POSITION EVENTUALLY. THE PHYSICIAN COMMENTED HE MIGHT MISJUDGE THE DELIVERY WIRE LENGTH. ALL LABELING INSTRUCTIONS WERE FOLLOWED FOR DEPLOYMENT WITH THE PROWLER SELECT PLUS MICROCATHETER (606-S255FX/LOT 15196926). OTHER PRODUCTS USED DURING THE PROCEDURE CONSISTED OF ECHELON 14 MC, ROAD MASTER 7FRENCH GUIDING CATHETER, SILVER SPEED GUIDEWIRE, 40 ORBIT COILS (638CS1230 /LOT 15137037, 638CF0925/LOT 15159096, 638CF0925/LOT 15159096, 638CF0824/LOT 15158719 X2, 638CF0721/LOT 15147547, 638CF0721/LOT 15161042, 637CF0515/(LOT 15172921, GALAXY 13500145 X3, 637HF0208/LOT 15122082, 637HF0208/LOT 15141593 X2, 637HF0208/LOT 15169078 X2, 637HF0310/LOT 15182283, 637MF0410/LOT 15178883, 637HF0310/LOT 15182283 X3, 637HF0310/LOT 15174573 X2, GALAXY LOT: 13500204 X5, 637HF0310/LOT 15174573, 637HF0310/LOT 15140373, 637HF0208/LOT 15181125, 637HF0310/LOT 15182282 X3, 637HF0310/LOT 15111896 X2, 637HF0208/LOT 15181125, 637HF0310/LOT 15141582, 637MF0410/LOT 15178883, 637MF0410/LOT 16126487, GDC (QTY 3), ED (QTY 2), AND PRESIDIO (QTY 2). THE ANTIPLATELET THERAPY CONSISTED OF ASPIRIN 100MG/DAY ((B)(6) 2011) AND PLAVIX 75MG/DAY ((B)(6) 2011). THE UNRUPTURED ANEURYSM NECK MEASURE 7.0MM AND THE NECK TO SAC RATIO WAS 7.0MM/ 15.0MM, AND THE PARENT VESSEL SIZE/DIAMETER PROXIMALLY WAS 3.0MM AND DISTALLY WAS 2.8MM. A CD COPY OF THE PROCEDURE IS NOT AVAILABLE. NO FURTHER INFORMATION WAS AVAILABLE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
THE REPORT FROM A CLINICAL STUDY (B)(4) FOR PATIENT WITH ID (B)(4) INDICATED THAT THE PROCEDURE WAS COIL EMBOLIZATION ASSISTED WITH THE ENTERPRISE VRD (ENC452812) STENT OF AN ANEURYSM IN THE BASILAR ARTERY, AND THE ENTERPRISE WAS ADVANCED TOO MUCH THAT THE STENT WAS DEPLOYED IN THE DISTAL VESSEL, BUT EVENTUALLY WAS PLACED IN THE CORRECT POSITION, AND THE COIL EMBOLIZATION WAS COMPLETED SUCCESSFULLY. HOWEVER, 2 DAYS AFTER THE PROCEDURE, THE PATIENT DEVELOPED STOKE (BLEEDING OF BRAIN STEM AROUND THE ANEURYSM) AND BRAIN EDEMA. HOWEVER, THE BLEEDING WAS NEITHER FROM THE ANEURYSM OR THE PARENT VESSEL, BUT THERE WAS NO INFORMATION EXACTLY WHERE THE BLEEDING OCCURRED. THE SYMPTOMS WERE HEMIPLEGIA (RIGHT SIDE), MILD DISORDER OF EYE MOVEMENT (BOTH SIDES), NUMBNESS OF RIGHT SIDE BODY, AND TRUNCAL ATAXIA. DRUG THERAPY WITH STEROID WAS DONE BUT RECOVERY WAS NOT CONFIRMED AS OF A MONTH AFTER ONSET OF SYMPTOMS. THE STENT WAS PATENT DURING THE EVENT, AND NO COIL WAS PROTRUDING INTO THE PARENT ARTERY.
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 | 01425605 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention |