PRECISE PRO RX CAROTID STENT SYSTEM
Report
- Report Number
- 9616099-2011-00583
- Event Type
- Injury
- Date Received
- August 5, 2011
- Date of Event
- June 9, 2011
- Report Date
- July 11, 2011
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIM
- PMA / PMN Number
- P030047
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF THREE PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH SR # (B)(4). THE COMPLAINT CONCLUSION HAS BEEN UPDATED TO REFLECT RECEIPT OF THE ADJUDICATION MINUTES. THE ADJUDICATION MINUTES RECEIVED (B)(4) 2012 DISAGREES WITH THE PREVIOUS DIAGNOSIS OF A TIA AS REPORTED BY THE SITE AND HAVE ADJUDICATED THE EVENT TO BE A CEREBROVASCULAR ACCIDENT. ALTHOUGH THE ADJUDICATION NOTES THAT THE PATIENT HAD COMPLETE RESOLUTION OF THE SYMPTOMS THE SITE HAD REPORTED PARTIAL RECOVERY WITH MINOR RESIDUALS. THIS DOES NOT CHANGE THE PREVIOUS DETERMINATION. AS REPORTED BY THE (B)(6) STUDY, FOLLOWING THE PROCEDURE THE PATIENT EXPERIENCED AMAUROSIS FUGAX AND WAS DIAGNOSED WITH TRANSIENT ISCHEMIC ATTACK (TIA). DURING THE PROCEDURE, A DISSECTION OCCURRED. THE PATIENT WAS ASYMPTOMATIC PRIOR TO THE PROCEDURE. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT INTERNAL CAROTID ARTERY (ICA). THE LESION WAS DESCRIBED AS THROMBOSED, 85% STENOSED, 7.0MM IN LENGTH, ARCH TYPE I, ULCERATED, WITH >=3MM WIDTH CALCIFICATION. THE REFERENCE VESSEL WAS 7.0MM IN DIAMETER AND MILDLY TORTUOUS. NO PRE-DILATION WAS DONE. AN 8MM ANGIOGUARD RX WAS SUCCESSFULLY DEPLOYED BEYOND THE TARGET LESION FOLLOWED BY DEPLOYMENT OF AN 8X30MM PRECISE PRO RX STENT. HOWEVER, A TYPE D DISSECTION OF PRE-EXISTING ORGANIZED THROMBUS OCCURRED. THE DISSECTION WAS REPORTED AS RELATED TO THE INITIALLY IMPLANTED 8X30MM PRECISE STENT. THERE WERE RESIDUALS REPORTED AS 10-15%. A SECOND 8X30MM PRECISE STENT WAS IMPLANTED OVERLAPPING THE FIRST STENT FOLLOWED BY AN 8X40MM PRECISE STENT IN ORDER TO STABILIZE THE DISSECTION. THE ANGIOGUARD RX WAS REMOVED WITH NO DEBRIS NOTED IN THE BASKET. RESIDUAL STENOSIS WAS 10%. THERE WERE NO AIR BUBBLES PRESENT DURING THE PROCEDURE. THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITH NO NEUROLOGICAL DEFICIT. ONE HOUR POST-PROCEDURE THE PATIENT EXPERIENCED AMAUROSIS FUGAX DESCRIBED AS LEFT-SIDED VISUAL FIELD LOSS WHICH WAS DIAGNOSED AS A TIA. NO TREATMENT WAS GIVEN FOR THE TIA. THERE WAS NO HEMIPARESIS, HEMINEGLECT, OR HEMIATAXIA. THE ONSET WAS SUDDEN AND THE DURATION OF THE EVENT WAS UNKNOWN. THE PATIENT'S RECOVERY WAS PARTIAL WITH MINOR VISUAL FIELD DEFECT. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO CORDIS PRODUCT BUT WAS RELATED TO THE INDEX PROCEDURE. THE PATIENT'S MEDICAL HISTORY INCLUDES TRANSIENT ISCHEMIC ATTACK (TIA), PRIOR RIGHT AND LEFT CAROTID ENDARTERECTOMY, HYPERLIPIDEMIA, CORONARY ARTERY BYPASS GRAFT SURGERY, CORONARY ARTERY DISEASE, AND HYPERTENSION. (B)(4). 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 15227543 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4). 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 15329304 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4). 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 15246992 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. 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. DISSECTION IS A WELL-KNOWN AND EXTENSIVELY DOCUMENTED POTENTIAL COMPLICATION OF THIS TYPE OF PROCEDURE AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. VESSELS THAT ARE RESISTANT TO ANGIOPLASTY HAVE A HIGHER RISK OF INTIMAL DISSECTION DURING INTERVENTIONAL PROCEDURES. THE PHYSICAL MANIPULATION INHERENT IN THE STENT IMPLANTATION PROCEDURE INTENTIONALLY DISRUPTS THE VESSEL PLAQUE AND INTIMA IN AN EFFORT TO RECONSTRUCT VIABLE PATENT VASCULATURE AND TREAT THE ATHEROSCLEROTIC DISEASE PROCESS. AMAUROSIS FUGAX IS LOSS OF VISION IN ONE EYE DUE TO A TEMPORARY LACK OF BLOOD FLOW TO THE RETINA. IT IS THOUGHT TO OCCUR WHEN A PIECE OF PLAQUE IN THE CAROTID ARTERY BREAKS OFF AND TRAVELS TO THE RETINAL ARTERY IN THE EYE. PLAQUE IS A HARD SUBSTANCE THAT FORMS WHEN FAT, CHOLESTEROL, AND OTHER SUBSTANCES BUILD UP IN THE WALLS OF ARTERIES. PIECES OF PLAQUE CAN TRAVEL THROUGH THE BLOODSTREAM. VISION LOSS OCCURS AS LONG AS THE BLOOD SUPPLY TO THE ARTERY IS BLOCKED. ATHEROSCLEROSIS OF THE ARTERIES IN THE NECK IS THE MAIN RISK FACTOR FOR THIS CONDITION. RISK FACTORS FOR ATHEROSCLEROSIS INCLUDE HEART DISEASE, HIGH CHOLESTEROL, SMOKING, DIABETES, AND HIGH BLOOD PRESSURE. SYMPTOMS INCLUDE THE SUDDEN LOSS OF VISION IN ONE EYE. THIS USUALLY ONLY LASTS SECONDS BUT MAY LAST SEVERAL MINUTES. SOME PATIENTS DESCRIBE THE LOSS OF VISION AS A GRAY OR BLACK SHADE COMING DOWN OVER THEIR EYE. CEREBROVASCULAR ACCIDENT IS A KNOWN POTENTIAL RISK ASSOCIATED WITH IMPLANTING A STENT IN A CAROTID ARTERY AND IS LISTED IN THE IFU AS SUCH. IT CAN BE DEFINED AS A CEREBROVASCULAR DISORDER CAUSED BY DEPRIVATION OF BLOOD FLOW TO AN AREA OF THE BRAIN, GENERALLY AS A RESULT OF THROMBOSIS, EMBOLISM, OR REDUCED BLOOD PRESSURE. THE ACT OF STENT EXPANSION OR POST-DILATATION, TO OPTIMALLY OPPOSE A CAROTID STENT TO THE VESSEL WALL, TEMPORARILY OBSTRUCTS BLOOD FLOW TO THE CEREBRAL ARTERIES (ISCHEMIC PROCESS). THE PHYSICAL MANIPULATION OF THE CAROTID ARTERIES PRODUCES THE RISK OF DISLODGEMENT OF DEBRIS THAT MAY TRAVEL UPSTREAM TO THE CEREBRAL ARTERIES POTENTIALLY DISRUPTING PERFUSION. THIS ACT, INHERENT TO THE PROCEDURE MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. A BLOOD VESSEL THAT IS NOT BLOCKED, BUT IS EXTREMELY NARROWED, CAN ALSO CAUSE AN ISCHEMIC STROKE. THE BLOCKED OR NARROWED ARTERIES DEPRIVE BRAIN CELLS OF OXYGEN AND NUTRIENTS, LEADING TO NERVE CELL DEATH; 80% OF ALL STROKES ARE ISCHEMIC. DURING ISCHEMIC STROKE, DIMINISHED BLOOD FLOW INITIATES A SERIES OF EVENTS (CALLED ISCHEMIC CASCADE) THAT MAY RESULT IN ADDITIONAL, DELAYED DAMAGE TO BRAIN CELLS. EARLY MEDICAL INTERVENTION CAN HALT THIS PROCESS AND REDUCE THE RISK FOR IRREVERSIBLE COMPLICATIONS. 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.
THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2011-00582, 9616099-2011-00583, AND 9616099-2011-00584. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT. 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 15329304 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 NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. NO EXCURSIONS WERE FOUND FOR LOT 15329304.
THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2011-00582, 9616099-2011-00583, AND 9616099-2011-00584. AS REPORTED BY THE (B)(4) STUDY, FOLLOWING THE PROCEDURE THE PATIENT EXPERIENCED AMAUROSIS FUGAX AND WAS DIAGNOSED WITH TRANSIENT ISCHEMIC ATTACK (TIA). DURING THE PROCEDURE, A DISSECTION OCCURRED. THE PATIENT WAS ASYMPTOMATIC PRIOR TO THE PROCEDURE. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT INTERNAL CAROTID ARTERY (ICA). THE LESION WAS DESCRIBED AS THROMBOSED, 85% STENOSED, 7.0MM IN LENGTH, ARCH TYPE I, ULCERATED, WITH >=3MM WIDTH CALCIFICATION. THE REFERENCE VESSEL WAS 7.0MM IN DIAMETER AND MILDLY TORTUOUS. NO PRE-DILATION WAS DONE. AN 8MM ANGIOGUARD RX WAS SUCCESSFULLY DEPLOYED BEYOND THE TARGET LESION FOLLOWED BY DEPLOYMENT OF AN 8X30MM PRECISE PRO RX STENT. HOWEVER, A TYPE D DISSECTION OF PRE-EXISTING ORGANIZED THROMBUS OCCURRED. THE DISSECTION WAS REPORTED AS RELATED TO THE INITIALLY IMPLANTED 8X30MM PRECISE STENT. THERE WERE RESIDUALS REPORTED AS 10-15%. A SECOND 8X30MM PRECISE STENT WAS IMPLANTED OVERLAPPING THE FIRST STENT FOLLOWED BY AN 8X40MM PRECISE STENT IN ORDER TO STABILIZE THE DISSECTION. THE ANGIOGUARD RX WAS REMOVED WITH NO DEBRIS NOTED IN THE BASKET. RESIDUAL STENOSIS WAS 10%. THERE WERE NO AIR BUBBLES PRESENT DURING THE PROCEDURE. THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITH NO NEUROLOGICAL DEFICIT. ONE HOUR POST-PROCEDURE, THE PATIENT EXPERIENCED AMAUROSIS FUGAX DESCRIBED AS LEFT-SIDED VISUAL FIELD LOSS WHICH WAS DIAGNOSED AS A TIA. NO TREATMENT WAS GIVEN FOR THE TIA. THERE WAS NO HEMIPARESIS, HEMINEGLECT, OR HEMIATAXIA. THE ONSET WAS SUDDEN AND THE DURATION OF THE EVENT WAS UNKNOWN. THE PATIENT'S RECOVERY WAS PARTIAL WITH MINOR VISUAL FIELD DEFECT. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO CORDIS PRODUCT BUT WAS RELATED TO THE INDEX PROCEDURE. THE PATIENT'S MEDICAL HISTORY INCLUDES TRANSIENT ISCHEMIC ATTACK (TIA), PRIOR RIGHT AND LEFT CAROTID ENDARTERECTOMY, HYPERLIPIDEMIA, CORONARY ARTERY BYPASS GRAFT SURGERY, CORONARY ARTERY DISEASE, AND HYPERTENSION. (B)(4): 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 15227543 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4): 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 15329304 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4): 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 15246992 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. 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. DISSECTION IS A WELL-KNOWN AND EXTENSIVELY DOCUMENTED POTENTIAL COMPLICATION OF THIS TYPE OF PROCEDURE AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. VESSELS THAT ARE RESISTANT TO ANGIOPLASTY HAVE A HIGHER RISK OF INTIMAL DISSECTION DURING INTERVENTIONAL PROCEDURES. THE PHYSICAL MANIPULATION INHERENT IN THE STENT IMPLANTATION PROCEDURE INTENTIONALLY DISRUPTS THE VESSEL PLAQUE AND INTIMA IN AN EFFORT TO RECONSTRUCT VIABLE PATENT VASCULATURE AND TREAT THE ATHEROSCLEROTIC DISEASE PROCESS. AMAUROSIS FUGAX IS LOSS OF VISION IN ONE EYE DUE TO A TEMPORARY LACK OF BLOOD FLOW TO THE RETINA. IT IS THOUGHT TO OCCUR WHEN A PIECE OF PLAQUE IN THE CAROTID ARTERY BREAKS OFF AND TRAVELS TO THE RETINAL ARTERY IN THE EYE. PLAQUE IS A HARD SUBSTANCE THAT FORMS WHEN FAT, CHOLESTEROL, AND OTHER SUBSTANCES BUILD UP IN THE WALLS OF ARTERIES. PIECES OF PLAQUE CAN TRAVEL THROUGH THE BLOODSTREAM. VISION LOSS OCCURS AS LONG AS THE BLOOD SUPPLY TO THE ARTERY IS BLOCKED. ATHEROSCLEROSIS OF THE ARTERIES IN THE NECK IS THE MAIN RISK FACTOR FOR THIS CONDITION. RISK FACTORS FOR ATHEROSCLEROSIS INCLUDE HEART DISEASE, HIGH CHOLESTEROL, SMOKING, DIABETES, AND HIGH BLOOD PRESSURE. SYMPTOMS INCLUDE THE SUDDEN LOSS OF VISION IN ONE EYE. THIS USUALLY ONLY LASTS SECONDS BUT MAY LAST SEVERAL MINUTES. SOME PATIENTS DESCRIBE THE LOSS OF VISION AS A GRAY OR BLACK SHADE COMING DOWN OVER THEIR EYE. TRANSIENT ISCHEMIC ATTACK (TIA) IS OFTEN ASSOCIATED WITH A TEMPORARY STOPPAGE OR SLOWING OF BLOOD FLOW TO THE CEREBRAL ARTERIES. THE PHYSICAL MANIPULATION OF THE CAROTID ARTERIES PRODUCES THE RISK OF DISLODGEMENT OF DEBRIS THAT MAY COLLECT IN THE EMBOLIC PROTECTION DEVICE OR FLOW DOWNSTREAM POTENTIALLY DISRUPTING PERFUSION. TIA OCCURS WHEN THE BLOOD SUPPLY TO PART OF THE BRAIN IS BRIEFLY INTERRUPTED. TIA SYMPTOMS ARE SIMILAR TO THOSE OF STROKE BUT DO NOT LAST AS LONG. MOST SYMPTOMS OF A TIA DISAPPEAR WITHIN AN HOUR. THERE IS NO EVIDENCE THAT MANUFACTURING ISSUES CONTRIBUTED TO THE EVENT. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT, VESSEL/LESION AND POSSIBLY PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS.
THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2011-00582, 9616099-2011-00583, AND 9616099-2011-00584. ADDITIONAL INFORMATION: ((B)(4) 2012) THE ADJUDICATION MINUTES RECEIVED (B)(4) 2012 DISAGREES WITH THE PREVIOUS DIAGNOSIS OF A TIA AS REPORTED BY THE SITE AND HAVE ADJUDICATED THE EVENT TO BE A CEREBROVASCULAR ACCIDENT. ALTHOUGH THE ADJUDICATION NOTES THAT THE PATIENT HAD COMPLETE RESOLUTION OF THE SYMPTOMS THE SITE HAD REPORTED PARTIAL RECOVERY WITH MINOR RESIDUALS. THIS DOES NOT CHANGE THE PREVIOUS DETERMINATION. TO BETTER REFLECT THE ADJUDICATION DETERMINATION THE CURRENT CODE OF TIA WILL BE CHANGED TO 'CEREBROVASCULAR ACCIDENT' AND WILL REMAIN AS A REPORTABLE EVENT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.
THE PATIENT DID NOT HAVE ANY KNOWN ALLERGIES TO NITINOL, NICKEL, TITANIUM. A 6FR SHEATH INTRODUCER WAS USED. THERE WAS A TIGHT SEAL BETWEEN THE STENT DELIVERY SYSTEM (SDS) AND THE TUOHY BORST (HEMOSTASIS) VALVE OF THE SHEATH INTRODUCER/GUIDING CATHETER DURING ASPIRATION. THE USER ASPIRATED PRIOR TO CONTRAST INJECTIONS. THERE WAS NO THROMBUS IN THE STENT POST DEPLOYMENT. THE DISSECTION WAS OF PRE-EXISTING ORGANIZED THROMBUS IS OLD PATCH. THE DISSECTION WAS A TYPE D AND WAS RELATED TO THE 8X30MM PRECISE PRO RX STENT. THERE WERE RESIDUALS REPORTED AS 10-15%. NO TREATMENT WAS GIVEN FOR THE TIA. THE AMAUROSIS WAS NOTED ONE HOUR POST-PROCEDURE. THERE WAS IMPROVED VISION BUT THE PATIENT WAS STILL WITH SMALL VISUAL FIELD DEFECT.
AS REPORTED BY THE (B)(4) STUDY, FOLLOWING THE PROCEDURE THE PATIENT EXPERIENCED AMAUROSIS FUGAX AND WAS DIAGNOSED WITH TRANSIENT ISCHEMIC ATTACK (TIA). DURING THE PROCEDURE, A DISSECTION OCCURRED. THE PATIENT WAS ASYMPTOMATIC PRIOR TO THE PROCEDURE. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT INTERNAL CAROTID ARTERY (ICA). THE LESION WAS DESCRIBED AS THROMBOSED, 85% STENOSED, 7.0MM IN LENGTH, ARCH TYPE I, ULCERATED, WITH >=3MM WIDTH CALCIFICATION. THE REFERENCE VESSEL WAS 7.0MM IN DIAMETER AND MILDLY TORTUOUS. NO PRE-DILATION WAS DONE. AN 8MM ANGIOGUARD RX WAS SUCCESSFULLY DEPLOYED BEYOND THE TARGET LESION. AN 8X30MM PRECISE PRO RX STENT WAS SUCCESSFULLY IMPLANTED. A SECOND 8X30MM PRECISE PRO RX STENT WAS IMPLANTED OVERLAPPING THE STENT AND TO STABILIZE DISSECTION. A THIRD 8X40MM PRECISE PRO RX STENT WAS IMPLANTED TO STABILIZE THE DISSECTION. THE ANGIOGUARD RX WAS REMOVED WITH NO DEBRIS NOTED IN THE BASKET. RESIDUAL STENOSIS WAS 10%. THERE WERE NO AIR BUBBLES PRESENT DURING THE PROCEDURE. THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITH NO NEUROLOGICAL DEFICIT. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED AMAUROSIS FUGAX DESCRIBED AS LEFT-SIDED VISUAL FIELD LOSS. THE PATIENT WAS DIAGNOSED WITH TIA. THERE WAS NO HEMIPARESIS, HEMINEGLECT, OR HEMIATAXIA. THE ONSET WAS SUDDEN AND THE DURATION OF THE EVENT WAS UNKNOWN. THE PATIENT'S RECOVERY WAS PARTIAL WITH MINOR RESIDUAL. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO CORDIS PRODUCT. THE EVENT WAS RELATED TO THE INDEX PROCEDURE.
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 | 15329304 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Other | 8MM ANGIOGUARD RX |