PRECISE PRO RX CAROTID STENT SYSTEM
Report
- Report Number
- 9616099-2012-00458
- Event Type
- Death
- Date Received
- August 23, 2012
- Date of Event
- May 11, 2012
- Report Date
- August 2, 2012
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIM
- PMA / PMN Number
- P030047
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
THE REPORT FROM THE (B)(4) STUDY INDICATED THAT TEN DAYS POST INDEX PROCEDURE CLOTS WERE FOUND PROXIMAL AND DISTAL TO THE CAROTID STENT AND REPEAT HEAD CT SHOWED BILATERAL INFRACT. BASELINE NIH AND RANKIN SCORES WERE EACH 0. PTA WAS PERFORMED ON AN 80% OCCLUDED LESION IN THE DISTAL RIGHT BASILAR INTERNAL CAROTID ARTERY OF 20 MM IN LENGTH IN AN 8.0 MM VESSEL DIAMETER WITH MODERATE VESSEL TORTUOUSITY. THE ARCH I LESION WAS ULCERATED AND SEVERELY CALCIFIED. AN ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS SUCCESSFULLY DEPLOYED FOLLOWED BY DEPLOYMENT OF A PRECISE PRO RX STENT WITH A RESIDUAL DIAMETER STENOSIS OF 20%. THE PATIENT WAS NEUROLOGICALLY INTACT UPON LEAVING THE ANGIO SUITE AND WAS DISCHARGED THE FOLLOWING DAY WITHOUT ANY MAJOR ADVERSE EVENTS. BASELINE NIH AND RANKIN SCORES WERE UNCHANGED AT DISCHARGE. THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL AFTER A FALL. CLOTS WERE FOUND PROXIMAL AND DISTAL TO THE STENT BUT THE PHYSICIAN COULD ONLY REMOVE THE PROXIMAL ONE AFTER 5 HOURS OF SURGERY. PATIENT WAS KEPT INTUBATED AND RE-EVALUATED THE NEXT MORNING WHEN REPEAT HEAD CT SHOWED COMPLETE RIGHT HEMISPHERIC INFARCT WITH WATERSHED INFARCT IN THE LEFT HEMISPHERE. FAMILY ELECTED FOR COMFORT CARE MEASURES, THE PATIENT WAS EXTUBATED AND SUBSEQUENTLY EXPIRED. THE PATIENT'S MEDICAL HISTORY INCLUDES HYPERLIPIDEMIA, HISTORY OF SMOKING AND HYPERTENSION WITH HIGH RISK CRITERIA INCLUDING CONTRALATERAL CAROTID OCCLUSION. 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 15387032 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. EMBOLIC STROKES ARE USUALLY CAUSED BY AN EMBOLUS (A BLOOD CLOT THAT FORMS ELSEWHERE IN THE BODY AND TRAVELS THROUGH THE BLOODSTREAM TO THE BRAIN) THAT TRAVELS FROM OTHER PARTS OF THE BODY TO THE NECK OR BRAIN AND BLOCKS A BLOOD VESSEL. EMBOLIC STROKES OFTEN RESULT FROM HEART DISEASE OR HEART SURGERY AND OCCUR RAPIDLY AND WITHOUT ANY WARNING SIGNS. ABOUT 15 PERCENT OF EMBOLIC STROKES OCCUR IN PEOPLE WITH ATRIAL FIBRILLATION. WHEN A CLOT FORMS IN A BLOOD VESSEL IN THE BRAIN OR NECK IT IS CALLED A THROMBOTIC STROKE. EMBOLIC AND THROMBOTIC STROKES ARE CATEGORIZED AS ISCHEMIC STROKE. THERE IS NO EVIDENCE THAT MANUFACTURING ISSUES CONTRIBUTED TO THE EVENT. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT, VESSEL AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS.
ON (B)(6) 2012, THE PATIENT PRESENTED TO AN OUTLYING HOSPITAL AFTER HE BECAME DIZZY AND FELL OFF A STOOL, HITTING HIS HEAD. INITIALLY, (EXACT TIME UNKNOWN) THE PHYSICAL EXAM REVEALED A LEFT PRONATOR DRIFT. THE PATIENT WAS UNABLE TO DO FINGER TO NOSE ON THE LEFT. THE NIH STROKE SCALE WAS 2. ACCORDING TO THE EMERGENCY ROOM NOTE, ON (B)(6) 2012 AT 18:41, THE NIH STROKE SCALE SCORE INCREASED TO 8 (ATTRIBUTIONS UNAVAILABLE). HE DEVELOPED FACIAL DROOP, DYSARTHRIA, AND LEFT-SIDED WEAKNESS. HE WAS TRANSFERRED TO THE ENROLLING HOSPITAL FOR INTERVENTION. A CT SCAN WITHOUT CONTRAST ON (B)(6) 2012 AT 16:27, SHOWED NO ACUTE ABNORMALITIES. A CT ANGIOGRAM OF THE HEAD AND NECK WITH AND WITHOUT CONTRAST ON (B)(6) 2012, REVEALED AN OCCLUSION OF THE METALLIC STENT AT THE RIGHT INTERNAL CAROTID ARTERY. THERE WAS NO FLOW IN THE DISTAL RIGHT INTERNAL CAROTID ARTERY WITHIN THE NECK TO THE LEVEL OF THE PROXIMAL PETROUS CAROTID ARTERY. ON (B)(6) 2012, THE PATIENT WAS BROUGHT THE OPERATING ROOM FOR A CEREBRAL ANGIOGRAM. THE RIGHT COMMON CAROTID ARTERY WAS SELECTED AND CERVICAL RUNS REVEALED A COMPLETE OCCLUSION OF THE RIGHT INTERNAL CAROTID ARTERY IN THE MID-STENT PORTION AS NOTED ON THE OPERATIVE REPORT. HE UNDERWENT ANGIOPLASTY AND A THROMBECTOMY IF THE ICA/MCA. THE PROXIMAL RIGHT CAROTID REVASCULARIZATION WAS SUCCESSFUL HOWEVER; THE INTRACRANIAL REVASCULARIZATION WAS UNSUCCESSFUL. HE WAS TRANSFERRED TO THE ICU INTUBATED AND SEDATED IN CRITICAL CONDITION. A CT SCAN WITHOUT CONTRAST ON (B)(6) 2012, REVEALED EXTENSIVE INFARCTION BILATERALLY. THERE WAS A LOSS OF GRAY-WHITE DIFFERENTIATION THE RIGHT ANTERIOR AND LATERAL TO TEMPORAL LOBES, EXTENDING CONTIGUOUSLY TO THE RIGHT OCCIPITAL LOBE, RIGHT BASAL GANGLIA, RIGHT INSULA, RIGHT FRONTAL, AND RIGHT PARIETAL LOBES. ABNORMAL HIGH ATTENUATION IN THE RIGHT SUPRACLINOID ICA AND RIGHT MIDDLE CEREBRAL ARTERY WAS CONSISTENT WITH THROMBUS. THERE WAS A SUBTLE LOW-ATTENUATION IN THE LEFT LATERAL TEMPORAL LOBE THAT WAS SUSPICIOUS FOR ISCHEMIA OR INFARCTION. DUE TO THE PATIENT'S POOR PROGNOSIS, THE PATIENT'S FAMILY ELECTED FOR COMFORT CARE ONLY. THE SITE REPORTED THE DEATH ON (B)(6) 2012, HOWEVER, A QUERY HAS BEEN ISSUED TO CLARIFY THE DATE OF DEATH AS THE NEUROLOGY PROGRESS NOTE REPORTED THE PATIENT'S BLOOD PRESSURE ON (B)(6) 2012. IT FURTHER NOTED THAT HE WAS EXTUBATED AND DIED. THE SITE REPORTED THE DEATH AS NEUROLOGIC. THE REPORT FROM THE (B)(4) STUDY INDICATED THAT TEN DAYS POST INDEX PROCEDURE CLOTS WERE FOUND PROXIMAL AND DISTAL TO THE CAROTID STENT AND REPEAT HEAD CT SHOWED BILATERAL INFRACT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE CEC IDENTIFIED TWO EVENTS, STROKE AND REVASCULARIZATION. THEY OCCURRED NINE DAYS AFTER THE INDEX PROCEDURE, ONE DAY EARLIER THAN THE PREVIOUSLY REPORTED EVENTS. BASELINE NIH AND RANKIN SCORES WERE EACH 0. PTA WAS PERFORMED ON AN 80% OCCLUDED LESION IN THE DISTAL RIGHT BASILAR INTERNAL CAROTID ARTERY OF 20MM IN LENGTH IN AN 8.0MM VESSEL DIAMETER WITH MODERATE VESSEL TORTUOUSITY. THE ARCH I LESION WAS ULCERATED AND SEVERELY CALCIFIED. AN ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS SUCCESSFULLY DEPLOYED FOLLOWED BY DEPLOYMENT OF A PRECISE PRO RX STENT WITH A RESIDUAL DIAMETER STENOSIS OF 20%. THE PATIENT WAS NEUROLOGICALLY INTACT UPON LEAVING THE ANGIO SUITE AND WAS DISCHARGED THE FOLLOWING DAY WITHOUT ANY MAJOR ADVERSE EVENTS. BASELINE NIH AND RANKIN SCORES WERE UNCHANGED AT DISCHARGE. THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL AFTER A FALL. CLOTS WERE FOUND PROXIMAL AND DISTAL TO THE STENT BUT THE PHYSICIAN COULD ONLY REMOVE THE PROXIMAL ONE AFTER 5 HOURS OF SURGERY. PATIENT WAS KEPT INTUBATED AND RE-EVALUATED THE NEXT MORNING WHEN REPEAT HEAD CT SHOWED COMPLETE RIGHT HEMISPHERIC INFARCT WITH WATERSHED INFARCT IN THE LEFT HEMISPHERE. FAMILY ELECTED FOR COMFORT CARE MEASURES, THE PATIENT WAS EXTUBATED AND SUBSEQUENTLY EXPIRED. THE PATIENTS MEDICAL HISTORY INCLUDES HYPERLIPIDEMIA, HISTORY OF SMOKING AND HYPERTENSION WITH HIGH RISK CRITERIA INCLUDING CONTRALATERAL CAROTID OCCLUSION. 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 15387032 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. EMBOLIC STROKES ARE USUALLY CAUSED BY AN EMBOLUS (A BLOOD CLOT THAT FORMS ELSEWHERE IN THE BODY AND TRAVELS THROUGH THE BLOODSTREAM TO THE BRAIN) THAT TRAVELS FROM OTHER PARTS OF THE BODY TO THE NECK OR BRAIN AND BLOCKS A BLOOD VESSEL. EMBOLIC STROKES OFTEN RESULT FROM HEART DISEASE OR HEART SURGERY AND OCCUR RAPIDLY AND WITHOUT ANY WARNING SIGNS. ABOUT 15 PERCENT OF EMBOLIC STROKES OCCUR IN PEOPLE WITH ATRIAL FIBRILLATION. WHEN A CLOT FORMS IN A BLOOD VESSEL IN THE BRAIN OR NECK IT IS CALLED A THROMBOTIC STROKE. EMBOLIC AND THROMBOTIC STROKES ARE CATEGORIZED AS ISCHEMIC STROKE. THERE IS NO EVIDENCE THAT MANUFACTURING ISSUES CONTRIBUTED TO THE EVENT. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT, VESSEL AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. IN-STENT RESTENOSIS (ISR) IS ASSOCIATED WITH THE PROGRESSION OF ATHEROSCLEROTIC DISEASE AND IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND DOES NOT REPRESENT A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS, IT IS NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. VESSEL OCCLUSION, RESTENOSIS, INTIMAL HYPERPLASIA OR RECURRENT STRICTURES ARE WELL KNOWN DOCUMENTED POTENTIAL COMPLICATIONS OF THIS TYPE OF PROCEDURE AND ARE LISTED IN THE IFU AS SUCH. RATES WERE HIGHER IN OLDER PATIENTS WITH MORE SEVERE ATHEROSCLEROSIS AND DEPENDED ON THE TYPE OF STENOSIS TREATED. ISR IS MORE PREVALENT IN OSTIAL STENT PLACEMENT PROCEDURES. STENOSES IN STENTS ARE USUALLY TREATED WITH INTRASTENT PTA OR PLACEMENT OF A SECOND STENT. FACTORS THAT MAY HAVE INFLUENCED THIS EVENT INCLUDE PATIENT, PROCEDURAL, PHARMACOLOGICAL AND LESION. THROMBOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS 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, STROKE 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.
THIS DEVICE IS NOT AVAILABLE FOR TESTING AND EVALUATION. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
ADDITIONAL INFORMATION WAS RECEIVED THAT THE CEC IDENTIFIED TWO EVENTS, STROKE AND REVASCULARIZATION RESULTING IN DEATH. THEY OCCURRED NINE DAYS AFTER THE INDEX PROCEDURE, ONE DAY EARLIER THAN THE PREVIOUSLY REPORTED EVENTS. A CHANGE IN THE PREVIOUSLY REPORTED PATIENT CODES ARE THEREFORE NOT REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DIED ON (B)(4) 2012 AND THEREFORE, WAS UPDATED RESULTING IN THE SUBMISSION OF THIS REPORT. NO FURTHER INFORMATION IS AVAILABLE AND FURTHER REPORTS WILL NOT BE FORTHCOMING.
PLEASE NOTE THAT THE PREVIOUS REPORT INDICATED THAT THERE WAS NO FLOW IN THE DISTAL RIGHT CAROTID. (B)(4). THE REPORT FROM THE (B)(4) STUDY INDICATED THAT TEN DAYS POST INDEX PROCEDURE THE PATIENT EXPERIENCED AN EMBOLIC STROKE. ADDITIONALLY IT WAS NOTED THAT THERE WAS NO FLOW IN THE DISTAL RIGHT INTERNAL CAROTID ARTERY SECONDARY TO AN OCCLUSION WITHIN THE STUDY DEVICE REQUIRING REVASCULARIZATION THAT WAS UNSUCCESSFUL. THE PATIENT SUBSEQUENTLY EXPIRED ON THE FOLLOWING DAY DUE TO NEUROLOGIC CAUSES. BASELINE NIH AND RANKIN SCORES WERE EACH 0. PTA WAS PERFORMED ON AN 80% OCCLUDED LESION IN THE DISTAL RIGHT BASILAR INTERNAL CAROTID ARTERY OF 20 MM IN LENGTH, 8.0 MM IN DIAMETER WITH MODERATE VESSEL TORTUOUSITY. THE ARCH I LESION WAS ULCERATED AND SEVERELY CALCIFIED. AN ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS SUCCESSFULLY DEPLOYED FOLLOWED BY SUCCESSFUL DEPLOYMENT OF A PRECISE PRO RX STENT WITH A RESIDUAL DIAMETER STENOSIS OF 20%. THE PATIENT WAS NEUROLOGICALLY INTACT UPON LEAVING THE ANGIO SUITE AND WAS DISCHARGED THE FOLLOWING DAY WITHOUT ANY MAJOR ADVERSE EVENTS. BASELINE NIH AND RANKIN SCORES WERE UNCHANGED AT DISCHARGE. THE PATIENT PRESENTED TO AN OUTLYING HOSPITAL APPROXIMATELY 10 DAYS LATER AFTER HE BECAME DIZZY AND FELL OFF A STOOL, HITTING HIS HEAD. INITIALLY, (EXACT TIME UNKNOWN) THE PHYSICAL EXAM REVEALED A LEFT PRONATOR DRIFT AND THE PATIENT WAS UNABLE TO DO FINGER TO NOSE ON THE LEFT. THE NIH STROKE SCALE WAS 2. ACCORDING TO THE EMERGENCY ROOM NOTE, ON (B)(6) 2012 AT 18:41, THE NIH STROKE SCALE SCORE INCREASED TO 8 (ATTRIBUTIONS UNAVAILABLE) AS HE DEVELOPED FACIAL DROOP, DYSARTHRIA, AND LEFT-SIDED WEAKNESS. HE WAS TRANSFERRED TO THE ENROLLING HOSPITAL FOR INTERVENTION WHERE A CT SCAN WITHOUT CONTRAST ON (B)(6) 2012 AT 16:27, SHOWED NO ACUTE ABNORMALITIES. A CT ANGIOGRAM OF THE HEAD AND NECK WITH AND WITHOUT CONTRAST ON (B)(6) 2012, REVEALED AN OCCLUSION OF THE METALLIC STENT AT THE RIGHT INTERNAL CAROTID ARTERY. THERE WAS NO FLOW IN THE DISTAL RIGHT INTERNAL CAROTID ARTERY WITHIN THE NECK TO THE LEVEL OF THE PROXIMAL PETROUS CAROTID ARTERY. ON (B)(6) 2012, THE PATIENT WAS BROUGHT THE OPERATING ROOM FOR A CEREBRAL ANGIOGRAM. THE RIGHT COMMON CAROTID ARTERY WAS SELECTED AND CERVICAL RUNS REVEALED A COMPLETE OCCLUSION OF THE RIGHT INTERNAL CAROTID ARTERY IN THE MID-STENT PORTION. HE UNDERWENT ANGIOPLASTY AND A THROMBECTOMY OF THE ICA/MCA. THE PROXIMAL RIGHT CAROTID REVASCULARIZATION WAS SUCCESSFUL HOWEVER; THE INTRACRANIAL REVASCULARIZATION WAS UNSUCCESSFUL. HE WAS TRANSFERRED TO THE ICU INTUBATED AND SEDATED IN CRITICAL CONDITION. A CT SCAN WITHOUT CONTRAST ON (B)(6) 2012, REVEALED EXTENSIVE INFARCTION BILATERALLY AND ABNORMAL HIGH ATTENUATION IN THE RIGHT SUPRACLINIOD ICA AND RIGHT MIDDLE CEREBRAL ARTERY WAS CONSISTENT WITH THROMBUS. DUE TO THE PATIENT'S POOR PROGNOSIS, THE PATIENT'S FAMILY ELECTED FOR COMFORT CARE ONLY. THE SITE REPORTED THE DEATH ON (B)(6) 2012, HOWEVER; A QUERY HAS BEEN ISSUED TO CLARIFY THE DATE OF DEATH AS THE NEUROLOGY PROGRESS NOTE REPORTED THAT THE PATIENT'S HAD A BLOOD PRESSURE ON (B)(6) 2012. IT FURTHER NOTED THAT HE WAS EXTUBATED AND DIED. THE SITE REPORTED THE DEATH AS NEUROLOGIC. 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. EMBOLIC STROKES ARE USUALLY CAUSED BY AN EMBOLUS (A BLOOD CLOT THAT FORMS ELSEWHERE IN THE BODY AND TRAVELS THROUGH THE BLOODSTREAM TO THE BRAIN) THAT TRAVELS FROM OTHER PARTS OF THE BODY TO THE NECK OR BRAIN AND BLOCKS A BLOOD VESSEL. EMBOLIC STROKES OFTEN RESULT FROM HEART DISEASE OR HEART SURGERY AND OCCUR RAPIDLY AND WITHOUT ANY WARNING SIGNS. ABOUT 15 PERCENT OF EMBOLIC STROKES OCCUR IN PEOPLE WITH ATRIAL FIBRILLATION. WHEN A CLOT FORMS IN A BLOOD VESSEL IN THE BRAIN OR NECK IT IS CALLED A THROMBOTIC STROKE. EMBOLIC AND THROMBOTIC STROKES ARE CATEGORIZED AS ISCHEMIC STROKE. THROMBOSIS IS ALSO A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS 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 CAVATAS (CAROTID AND VERTEBRAL ARTERY TRANSLUMINAL ANGIOPLASTY STUDY) TRIAL, STROKE 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. THE HYPOPERFUSION WAS ALSO SECONDARY TO THE THROMBUS. THERE IS NO EVIDENCE THAT MANUFACTURING ISSUES CONTRIBUTED TO THE EVENT. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT, VESSEL, PHARMACEUTICAL AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS.
THE EMAIL RECEIVED FOR THE (B)(4) STUDY INDICATED THAT (B)(6) DAYS POST INDEX PROCEDURE CLOTS WERE FOUND PROXIMAL AND DISTAL TO THE CAROTID STENT AND REPEAT HEAD CT SHOWED BILATERAL INFRACT. BASELINE NIH AND RANKIN SCORES WERE EACH 0. PTA WAS PERFORMED ON AN 80% OCCLUDED LESION IN THE DISTAL RIGHT BASILAR INTERNAL CAROTID ARTERY OF 20 MM IN LENGTH IN AN 8.0 MM VESSEL DIAMETER WITH MODERATE VESSEL TORTUOSITY. THE ARCH I LESION WAS ULCERATED AND SEVERELY CALCIFIED. A 6MM MEDIUM SUPPORT ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS SUCCESSFULLY DEPLOYED FOLLOWED BY DEPLOYMENT AT THE TARGET SITE OF AN 8X40 MM PRECISE PRO RX STENT. THE RESIDUAL DIAMETER STENOSED MEASURED 20%. THE PATIENT WAS NEUROLOGICALLY INTACT UPON LEAVING THE ANGIO SUITE. THE PATIENT WAS DISCHARGED ON THE FOLLOWING DAY WITHOUT ANY MAJOR ADVERSE EVENTS. BASELINE NIH AND RANKIN SCORES WERE UNCHANGED AT DISCHARGE. THE PATIENT WAS ADMITTED TO HOSPITAL AFTER A FALL. CLOTS WERE FOUND PROXIMAL AND DISTAL TO THE STENT, BUT THE PHYSICIAN COULD ONLY REMOVE THE PROXIMAL ONE AFTER 5 HOURS OF SURGERY. PATIENT WAS KEPT INTUBATED AND RE-EVALUATED THE NEXT MORNING. ON THE FOLLOWING DAY, REPEAT HEAD CT ALSO SHOWED COMPLETE RIGHT HEMISPHERIC INFARCT WITH WATERSHED INFARCT IN THE LEFT HEMISPHERE. FAMILY ELECTED FOR COMFORT CARE MEASURED AND THE PATIENT WAS EXTUBATED. THE PATIENT SUBSEQUENTLY DIED.
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 | 15387032 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Death | ANGIOGUARD RX: (LOT# 70910513, CAT# 601814REC) |