PRECISE PRO RX CAROTID STENT SYSTEM
Report
- Report Number
- 9616099-2011-00462
- Event Type
- Injury
- Date Received
- July 7, 2011
- Date of Event
- June 3, 2011
- Report Date
- June 7, 2011
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIM
- PMA / PMN Number
- P030047
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
HE WAS NOT MOVING HIS BILATERAL LEGS ON COMMAND. THERE WAS SOME SPONTANEOUS MOVEMENT INTERMITTENTLY, POSSIBLY 3 TO 4/5 STRENGTH IN THE LEGS BUT MAYBE LESS ON THE LEFT LEG, APPEARED ALMOST TO BE A LITTLE ATAXIC. DID THRUST HIS TONGUE OUT ON COMMAND AND DID PERFORM EXTRAOCULAR MOVEMENTS ON COMMAND DURING THE EXAM, FOLLOWING COMMANDS. APPEARED TO POSSIBLY HAVE A LITTLE LEFT-SIDED NEGLECT. THERE IS 70% RECOVERY AND STILL IMPROVING. FOR THE INDEX PROCEDURE, THE PATIENT WAS ADMITTED ASYMPTOMATIC WITH 90% STENOSIS IN THE PROXIMAL LEFT INTERNAL CAROTID ARTERY. THE LESION WAS AN IN-STENT RESTENOSIS OF AN ABBOTT ACCULINK 7MM X 40MM STENT, ECCENTRIC, WITH MILD VESSEL TORTUOSITY AND CIRCUMFERENTIAL CALCIFICATION. 7 X 40MM PRECISE PRO RX STENT WAS DEPLOYED. A 7 X 40MM PRECISE PRO RX STENT WAS DEPLOYED SUCCESSFULLY, WITH NO STENT MALFUNCTION AND NOT ASSOCIATED MAJOR ADVERSE EVENT. AN ANGIOGUARD RX WAS SUCCESSFULLY DEPLOYED AND RETRIEVED WITH NO TECHNICAL PROBLEMS OR ASSOCIATED MAJOR ADVERSE EVENT. CONCOMITANT MEDICAL PRODUCTS: (B)(6) 2011: MUCOMYST, INTRA-PROCEDURE:BICARBONATE, D5W, HEPARIN 2000 UNITS (8:50AM), HEPARIN 3000 UNITS (9:40AM). FENTANYL, VERSED, HYDRALAZINE, LABETALOL 200MG, ZOFRAN, PLAVIX 75MG, ASPIRIN 81MG, OMEPRAZOLE 20MG, CARDENE, TYLENOL AND DOPAMINE. FOR THE INDEX PROCEDURE, THE PATIENT WAS ADMITTED ASYMPTOMATIC WITH 90% STENOSIS IN THE PROXIMAL LEFT INTERNAL CAROTID ARTERY. THE LESION WAS AN IN-STENT RESTENOSIS OF AN ABBOTT ACCULINK 7MM X 40MM STENT, DESCRIBED AS ECCENTRIC, WITH MILD VESSEL TORTUOSITY AND CIRCUMFERENTIAL CALCIFICATION. A 7 X 40MM PRECISE PRO RX STENT WAS DEPLOYED SUCCESSFULLY, WITH NO STENT MALFUNCTION. AN ANGIOGUARD RX WAS SUCCESSFULLY DEPLOYED AND RETRIEVED WITH NO TECHNICAL PROBLEMS. DURING THE INDEX PROCEDURE, THE PATIENT EXPERIENCED A HYPERTENSIVE EVENT WHICH WAS TREATED WITH MEDICATIONS. THREE DAYS AFTER THE INDEX PROCEDURE, THE PATIENT HAD A STENT THROMBOSIS THAT WAS REPORTED TO BE RELATED TO THE INDEX PROCEDURE AND UNRELATED TO THE CORDIS PRODUCT. AN MRA WAS PERFORMED WHICH SUGGESTED LEFT INTERNAL CAROTID ARTERY (ICA) STENT THROMBOSIS. HOWEVER, THE PHYSICIAN WHO REVIEWED THE CAROTID ULTRASOUND THREE DAYS AFTER THE INDEX PROCEDURE THOUGHT THE MRA INTERPRETATION WAS OVERESTIMATED DUE TO THE IMPACT OF MULTIPLE STENTS ON THE IMAGES AND FEELS THAT THE STENT IS PATENT. THE EVENT REMAINS UNDETERMINED. TEN DAYS POST-PROCEDURE, THE PATIENT HAD AN ACUTE BILATERAL HEMISPHERE CEREBROVASCULAR ACCIDENT. THE PATIENTS MEDICAL HISTORY INCLUDES PRE-OCCLUSIVE LEFT DISTAL INTERNAL CAROTID STENOSIS, PRIOR LEFT CAROTID STENT PLACEMENT AROUND (B)(6) 2009 AND IS STATUS POST ANOTHER LEFT CAROTID STENT PER ABOVE PROCEDURE. THE PATIENT HAS ALSO HAD A LEFT CAROTID ENDARTERECTOMY, PERIPHERAL VASCULAR DISEASE AND MULTIPLE ARTERIAL STENOSES AND IS STATUS POST A RIGHT ILIAC STENT IN (B)(6) 2008, STATUS POST RIGHT COMMON FEMORAL, RIGHT TO LEFT FEMOROFEMORAL BYPASS AROUND (B)(6) 2008. PATIENT HAS KNOWN 5CM AORTIC ABDOMINAL ANEURYSM, CHRONIC RENAL INSUFFICIENCY, HYPERTENSION, CVA WITH DYSARTHRIA IN THE PAST, HARD OF HEARING. IN (B)(6) 2008, HAD AN ADENOSINE NUCLEAR STRESS TEST, NEGATIVE FOR CARDIAC ISCHEMIA WITH AN EF OF 71%. (B)(6) 2011, HAD A NUCLEAR ADENOSINE STRESS TEST, WHICH WAS AN ABNORMAL STUDY WITH A SMALL FIXED DEFECT IN THE INFERIOR SEGMENT SUGGESTING A PRIOR MYOCARDIAL INFARCTION BUT NO CURRENT ISCHEMIA WAS SEEN. THERE WAS NORMAL LV SIZE WITH MILDLY REDUCED SYSTOLIC FUNCTION WITH AN EF OF 45%. HISTORY OF DISLIPIDEMIA, MEDICAL NONCOMPLIANCE DUE TO SOME ISSUES OF SIDE EFFECTS COMPLAINING OF HEADACHES FROM DIFFERENT BLOOD PRESSURE MEDICINES IN THE PAST. HISTORY OF ATRIAL FIBRILLATION WITH RVR AROUND (B)(6) 2009 WITH AN INCREASE IN HIS CK-MB AND TROPONIN AT THAT TIME AND TOBACCO ABUSE. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS AND/OR VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT. THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT IS RELATED TO THE DESIGN OR MANUFACTURING PROCESS OF THE DEVICE. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15370317 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4). NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. NO EXCURSIONS WERE FOUND FOR LOT 15370317. NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. AN INVESTIGATION WAS REQUESTED TO (B)(4) AND THE RESULTS INDICATE THAT ALL STENTS SHIPPED MEETS SPECIFIED RELEASE REQUIREMENTS. HYPERTENSION IS A WELL KNOWN POTENTIAL ADVERSE EVENT POSSIBLE WITH ANY INVASIVE PROCEDURE. THROMBOSIS AND CVA ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND ARE LISTED IN THE IFU AS SUCH. THE ACT OF STENT IMPLANTATION PRODUCES INTENDED DAMAGE TO THE INTIMA OF THE VESSEL WALL IN ORDER TO REMODEL THE WALL AND REESTABLISH PATENCY OF THE VESSEL. THE DISRUPTION OF THE INTIMAL LAYERS TRIGGERS THE IMMUNE SYSTEM TO HEAL THE DAMAGED AREAS, THUS ACTIVATING THE CLOTTING MECHANISM AS WELL AS THE INFLAMMATORY RESPONSE. THE COMBINATION OF INFLAMMATORY RESPONSE AND CLOTTING CASCADE CAN LEAD TO THROMBUS FORMATION IN SIDE OF THE STENT AROUND THE DAMAGED AREAS. THROMBOSIS CAN CAUSE SERIOUS POST-PROCEDURAL COMPLICATIONS OF STENT OCCLUSION OR DISTAL EMBOLIZATION, RESULTING IN ACUTE CEREBRAL INFARCTION. ACUTE STENT THROMBOSIS RATE IS REPORTED TO BE APPROXIMATELY 0.5%. IN THE (B)(4) TRIAL, CEREBROVASCULAR ACCIDENT, A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH, OCCURRED IN 5% OF PATIENTS IMMEDIATELY OR SOON AFTER BALLOON DILATATION AND STENTING. ALTHOUGH THE INCIDENCE OF STROKE ATTRIBUTABLE TO ACUTE STENT THROMBOSIS IS UNCLEAR, A SUBSTANTIAL PROPORTION IS ASSUMED TO BE A DIRECT RESULT OF STENT THROMBOSIS OR AN INDIRECT RESULT BY DISTAL EMBOLIZATION. SEVERAL FACTORS, INCLUDING MECHANICAL PLAQUE DISRUPTION, INTIMAL INJURY, AND STENT THROMBOGENICITY PREDISPOSE THE PATIENT TO THROMBOEMBOLIC EVENTS. PLATELET ADHESION, ACTIVATION, AND AGGREGATION PLAY MAIN ROLES IN MURAL THROMBUS FORMATION.
FOR THE INDEX PROCEDURE, THE PATIENT WAS ADMITTED ASYMPTOMATIC WITH 90% STENOSIS IN THE PROXIMAL LEFT INTERNAL CAROTID ARTERY. THE LESION WAS AN IN-STENT RESTENOSIS OF AN ABBOTT ACCULINK 7MM X 40MM STENT, DESCRIBED AS ECCENTRIC, WITH MILD VESSEL TORTUOSITY AND CIRCUMFERENTIAL CALCIFICATION. A 7 X 40MM PRECISE PRO RX STENT WAS DEPLOYED SUCCESSFULLY, WITH NO STENT MALFUNCTION. AN ANGIOGUARD RX WAS SUCCESSFULLY DEPLOYED AND RETRIEVED WITH NO TECHNICAL PROBLEMS. DURING THE INDEX PROCEDURE, THE PATIENT EXPERIENCED A HYPERTENSIVE EVENT WHICH WAS TREATED WITH MEDICATIONS. THREE DAYS AFTER THE INDEX PROCEDURE, THE PATIENT HAD A STENT THROMBOSIS THAT WAS REPORTED TO BE RELATED TO THE INDEX PROCEDURE AND UNRELATED TO THE CORDIS PRODUCT. AN MRA WAS PERFORMED WHICH SUGGESTED LEFT INTERNAL CAROTID ARTERY (ICA) STENT THROMBOSIS. HOWEVER, THE PHYSICIAN WHO REVIEWED THE CAROTID ULTRASOUND THREE DAYS AFTER THE INDEX PROCEDURE THOUGHT THE MRA INTERPRETATION WAS OVERESTIMATED DUE TO THE IMPACT OF MULTIPLE STENTS ON THE IMAGES AND FEELS THAT THE STENT IS PATENT. THE EVENT REMAINS UNDETERMINED. TEN DAYS POST-PROCEDURE, THE PATIENT HAD AN ACUTE BILATERAL HEMISPHERE CEREBROVASCULAR ACCIDENT. NINETEEN DAYS AFTER THE INDEX PROCEDURE, THE PATIENT HAD A NON Q-WAVE MYOCARDIAL INFARCTION. THE EVENT WAS NOT TREATED AND THE CAUSE OF THE EVENT WAS UNKNOWN. THE EVENT WAS REPORTED TO BE UNRELATED TO THE INDEX PROCEDURE AND THE CORDIS PRODUCT. TWENTY THREE DAYS AFTER THE INDEX PROCEDURE, THE PATIENT HAD A BILATERAL SUBARACHNOID/INTRA-CEREBRAL HEMORRHAGIC STROKE. THE CAUSE OF THE EVENT IS UNKNOWN. THE PATIENT HAD BILATERAL REFLEX CHANGE AND DECREASED MENTAL STATUS. THE EVENT HAD A SUDDEN ONSET AND WAS NOT TREATED. THE PATIENT HAD RESIDUAL DECREASED MENTAL STATUS. THE EVENT WAS REPORTED TO BE UNRELATED TO THE INDEX PROCEDURE AND THE CORDIS PRODUCT. A MONTH A ONE DAY AFTER THE INDEX PROCEDURE, THE PATIENT DIED. THE CAUSE OF DEATH PER THE DEATH CERTIFICATE WAS ACUTE CEREBRAL ACCIDENT AND ACUTE RESPIRATORY FAILURE. NO AUTOPSY WAS PERFORMED. THE EVENT WAS REPORTED TO BE UNRELATED TO THE INDEX PROCEDURE AND THE CORDIS PRODUCT. THE PATIENTS MEDICAL HISTORY INCLUDES PRE-OCCLUSIVE LEFT DISTAL INTERNAL CAROTID STENOSIS, PRIOR LEFT CAROTID STENT PLACEMENT AROUND (B)(6) 2009 AND IS STATUS POST ANOTHER LEFT CAROTID STENT PER ABOVE PROCEDURE. THE PATIENT HAS ALSO HAD A LEFT CAROTID ENDARTERECTOMY, PERIPHERAL VASCULAR DISEASE AND MULTIPLE ARTERIAL STENOSES AND IS STATUS POST A RIGHT ILIAC STENT IN (B)(6) 2008, STATUS POST RIGHT COMMON FEMORAL, RIGHT TO LEFT FEMOROFEMORAL BYPASS AROUND (B)(6) 2008. PATIENT HAS KNOWN 5CM AORTIC ABDOMINAL ANEURYSM, CHRONIC RENAL INSUFFICIENCY, HYPERTENSION, CVA WITH DYSARTHRIA IN THE PAST, HEARD OF HEARING. IN (B)(6) 2008, HAD AN ADENOSINE NUCLEAR STRESS TEST, NEGATIVE FOR CARDIAC ISCHEMIA WITH AN EF OF 71%. ON (B)(6) 16, 2011, HAD A NUCLEAR ADENOSINE STRESS TEST, WHICH WAS AN ABNORMAL STUDY WITH A SMALL FIXED DEFECT IN THE INFERIOR SEGMENT SUGGESTING A PRIOR MYOCARDIAL INFARCTION BUT NO CURRENT ISCHEMIA WAS SEEN. THERE WAS NORMAL LV SIZE WITH MILDLY REDUCED SYSTOLIC FUNCTION WITH AN EF OF 45%. HISTORY OF DISLIPIDEMIA, MEDICAL NONCOMPLIANCE DUE TO SOME ISSUES OF SIDE EFFECTS COMPLAINING OF HEADACHES FROM DIFFERENT BLOOD PRESSURE MEDICINES IN THE PAST. HISTORY OF ATRIAL FIBRILLATION WITH RVR AROUND (B)(6) 2009 WITH AN INCREASE IN HIS CK-MB AND TROPONIN AT THAT TIME AND TOBACCO ABUSE. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS AND/OR VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT. THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT IS RELATED TO THE DESIGN OR MANUFACTURING PROCESS OF THE DEVICE. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15370317 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4). NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. NO EXCURSIONS WERE FOUND FOR LOT 15370317. NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. AN INVESTIGATION WAS REQUESTED TO (B)(4) AND THE RESULTS INDICATE THAT ALL STENTS SHIPPED MEETS SPECIFIED RELEASE REQUIREMENTS. HYPERTENSION IS A WELL KNOWN POTENTIAL ADVERSE EVENT POSSIBLE WITH ANY INVASIVE PROCEDURE. MYOCARDIAL INFARCTION (MI) OR ACUTE MYOCARDIAL INFARCTION (AMI), COMMONLY KNOWN AS A HEART ATTACK IS THE INTERRUPTION OF BLOOD SUPPLY TO PART OF THE HEART, CAUSING SOME HEART CELLS TO DIE. THIS IS MOST COMMONLY DUE TO OCCLUSION (BLOCKAGE) OF A CORONARY ARTERY FOLLOWING THE RUPTURE OF A VULNERABLE ATHEROSCLEROTIC PLAQUE, WHICH IS AN UNSTABLE COLLECTION OF LIPIDS (FATTY ACIDS) AND WHITE BLOOD CELLS (ESPECIALLY MACROPHAGES) IN THE WALL OF AN ARTERY. THERE IS NO MEDICAL EVIDENCE TO SUGGEST A RELATIONSHIP BETWEEN CAROTID ARTERY STENT IMPLANTATION AND THE REPORTED MI. THROMBOSIS AND CVA ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND ARE LISTED IN THE IFU AS SUCH. THE ACT OF STENT IMPLANTATION PRODUCES INTENDED DAMAGE TO THE INTIMA OF THE VESSEL WALL IN ORDER TO REMODEL THE WALL AND REESTABLISH PATENCY OF THE VESSEL. THE DISRUPTION OF THE INTIMAL LAYERS TRIGGERS THE IMMUNE SYSTEM TO HEAL THE DAMAGED AREAS, THUS ACTIVATING THE CLOTTING MECHANISM AS WELL AS THE INFLAMMATORY RESPONSE. THE COMBINATION OF INFLAMMATORY RESPONSE AND CLOTTING CASCADE CAN LEAD TO THROMBUS FORMATION IN SIDE OF THE STENT AROUND THE DAMAGED AREAS. THROMBOSIS CAN CAUSE SERIOUS POST-PROCEDURAL COMPLICATIONS OF STENT OCCLUSION OR DISTAL EMBOLIZATION, RESULTING IN ACUTE CEREBRAL INFARCTION. ACUTE STENT THROMBOSIS RATE IS REPORTED TO BE APPROXIMATELY 0.5%. IN THE (B)(4) TRIAL, CEREBROVASCULAR ACCIDENT, A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH, OCCURRED IN 5% OF PATIENTS IMMEDIATELY OR SOON AFTER BALLOON DILATATION AND STENTING. ALTHOUGH THE INCIDENCE OF STROKE ATTRIBUTABLE TO ACUTE STENT THROMBOSIS IS UNCLEAR, A SUBSTANTIAL PROPORTION IS ASSUMED TO BE A DIRECT RESULT OF STENT THROMBOSIS OR AN INDIRECT RESULT BY DISTAL EMBOLIZATION. SEVERAL FACTORS, INCLUDING MECHANICAL PLAQUE DISRUPTION, INTIMAL INJURY, AND STENT THROMBOGENICITY PREDISPOSE THE PATIENT TO THROMBOEMBOLIC EVENTS. PLATELET ADHESION, ACTIVATION, AND AGGREGATION PLAY MAIN ROLES IN MURAL THROMBUS FORMATION. INTRACEREBRAL HEMORRHAGE OCCURS WHEN A DISEASED BLOOD VESSEL WITHIN THE BRAIN BURSTS, ALLOWING BLOOD TO LEAK INSIDE THE BRAIN. THE SUDDEN INCREASE IN PRESSURE WITHIN THE BRAIN CAN CAUSE DAMAGE TO THE BRAIN CELLS SURROUNDING THE BLOOD. IF THE AMOUNT OF BLOOD INCREASES RAPIDLY, THE SUDDEN BUILDUP IN PRESSURE CAN LEAD TO UNCONSCIOUSNESS OR DEATH. INTRACEREBRAL HEMORRHAGE USUALLY OCCURS IN SELECTED PARTS OF THE BRAIN, INCLUDING THE BASAL GANGLIA, CEREBELLUM, BRAINSTEM, OR CORTEX. THE MOST COMMON CAUSE OF INTRACEREBRAL HEMORRHAGE IS HIGH BLOOD PRESSURE (HYPERTENSION). AFTER REVASCULARIZATION THAT ALLEVIATES A HIGH-GRADE SYMPTOMATIC STENOTIC LESION, CEREBRAL HYPERPERFUSION MAY OCCUR AS A RESULT OF A SUDDEN, RAPID INCREASE IN CEREBRAL BLOOD FLOW EXCESS OF THAT REQUIRED TO MEET METABOLIC DEMANDS. ANTICOAGULATION IS A KNOWN RISK FACTOR FOR BRAIN HEMORRHAGE IN PATIENTS WITH PRE-EXISTING DISEASE. LESS COMMON CAUSES OF INTRACEREBRAL HEMORRHAGE INCLUDE TRAUMA, INFECTIONS, TUMORS, BLOOD CLOTTING DEFICIENCIES, AND ABNORMALITIES IN BLOOD VESSELS (SUCH AS ARTERIOVENOUS MALFORMATIONS). TYPICALLY, INTRACEREBRAL HEMORRHAGE DEVELOPS ON THE THIRD TO FIFTH POSTOPERATIVE DAY, THOUGH THERE HAVE BEEN CASES OBSERVED IMMEDIATELY AFTER SURGERY, AS WELL AS CASES DEVELOPED 3 WEEKS AFTER REVASCULARIZATION. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS AND/OR VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THESE EVENTS. THERE IS NO EVIDENCE TO SUGGEST THAT THEY ARE RELATED TO THE DESIGN OR MANUFACTURING PROCESS OF THE DEVICE.
THE INFORMATION RECEIVED FROM THE (B)(4) STUDY INDICATED THAT DURING THE INDEX PROCEDURE, THE PATIENT HAD HYPERTENSION UP TO 210/192. THE EVENT WAS TREATED WITH HYDRALAZINE, ANCEF, LABETALOL 10MG AND ZOFRAN. THE DAY OF THE INDEX PROCEDURE, THE PATIENT EXPERIENCED AN ISCHEMIC STROKE. THE PATIENT HAD DYSARTHRIA AND LEFT HEMIPARESIS. THE EVENT HAD A SUDDEN ONSET. THE RECOVERY IS UNKNOWN. THE EVENT WAS REPORTED TO BE RELATED TO THE INDEX PROCEDURE AND UNRELATED TO THE CORDIS PRODUCT. THREE DAYS AFTER THE INDEX PROCEDURE, THE PATIENT HAD A STENT THROMBOSIS THAT WAS REPORTED TO BE RELATED TO THE INDEX PROCEDURE AND UNRELATED TO THE CORDIS PRODUCT. THE MRA SUGGESTED LEFT INTERNAL CAROTID ARTERY (ICA) STENT THROMBOSIS BUT CAROTID ULTRASOUND DONE THREE DAYS AFTER THE INDEX PROCEDURE WAS THOUGHT TO BE OVERESTIMATED BY THE PHYSICIAN DUE TO THE MULTIPLE STENT PLACEMENT. THE PHYSICIAN REVIEWING THE CAROTID ULTRASOUND FEELS THE STENT IS PATENT AT THIS TIME. TEN DAYS POST-PROCEDURE, THE PATIENT HAD AN ACUTE BILATERAL HEMISPHERE CEREBROVASCULAR ACCIDENT. THE PATIENT WAS NON-VERBAL, HAD A LEFT FACIAL DROOP, LEFT ARM HAS VERY WEAK GRIP, BUT HE WAS ABLE TO HOLD UP HIS LEFT ARM IN THE AIR WHEN LIFTED UP AND KEEP IT THERE WHEN LET GO.
ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED TWENTY THREE DAYS AFTER THE INDEX PROCEDURE THE PATIENT HAD A BILATERAL SUBARACHNOID/INTRA-CEREBRAL HEMORRHAGIC STROKE. THE CAUSE OF THE EVENT IS UNKNOWN. THE PATIENT HAD BILATERAL REFLEX CHANGE AND DECREASED MENTAL STATUS. THE EVENT HAD A SUDDEN ONSET AND WAS NOT TREATED. THE PATIENT HAD RESIDUAL DECREASED MENTAL STATUS. THE EVENT WAS REPORTED TO BE UNRELATED TO THE INDEX PROCEDURE AND THE CORDIS PRODUCT. A MONTH AND ONE DAY AFTER THE INDEX PROCEDURE, THE PATIENT DIED. THE CAUSE OF DEATH PER THE DEATH CERTIFICATE WAS ACUTE CEREBRAL ACCIDENT AND ACUTE RESPIRATORY FAILURE. NO AUTOPSY WAS PERFORMED. THE EVENT WAS REPORTED TO BE UNRELATED TO THE INDEX PROCEDURE AND THE CORDIS PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISE PRO RX CAROTID STENT SYSTEM | SELF EXPANDING STENTS (NIM) | NIM | CORDIS DE MEXICO | NA | 15370317 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Hospitalization| L| R | ANGIOGUARD RX |