PRECISE PRO RX CAROTID STENT SYSTEM
Report
- Report Number
- 9616099-2011-00143
- Event Type
- Injury
- Date Received
- February 28, 2011
- Date of Event
- January 28, 2011
- Report Date
- March 30, 2011
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIM
- PMA / PMN Number
- P030047
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
THE (B)(6) FEMALE PATIENT HAD THE FOLLOWING MEDICAL HISTORY: SEVERE PULMONARY DISEASE, HYPERLIPIDEMIA, CLINICAL COPD, CONGESTIVE HEART FAILURE, CORONARY ARTERY DISEASE, CORONARY PERCUTANEOUS REVASCULARIZATION AND HYPERTENSION. THE PATIENT WAS PART OF THE (B)(4) STUDY AND HAD A PRECISE STENT IMPLANTED IN THE LEFT INTERNAL CAROTID ARTERY. TWO DAYS POST INDEX PROCEDURE THE PATIENT HAD A TIA LIKE EPISODE WITH DYSARTHRIA FOR APPROXIMATELY 20 MINUTES, WENT TO THE ER, AND WAS GIVEN PLAVIX, ASPIRIN AND CILOSTAZOL. PATIENT WAS NOT ADMITTED TO THE HOSPITAL AND IS FULLY RECOVERED. 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 15036728 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. 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. TIA IS A WELL-KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE. TIA SYMPTOMS ARE SIMILAR TO THOSE OF STROKE BUT DO NOT LAST AS LONG. TYPICALLY SYMPTOMS OF A TIA OFTEN LAST ONLY A FEW MINUTES, MOST SYMPTOMS RESOLVE WITHIN AN HOUR BUT THEY MAY LAST UP TO 24 HOURS. TIA OCCURS WHEN THE BLOOD SUPPLY TO PART OF THE BRAIN IS BRIEFLY INTERRUPTED. THE HEMODYNAMIC INSTABILITY THAT OCCURS BOTH DURING AND AFTER CAROTID STENT IMPLANTATION IS INFLUENCED BY THE BARO-RECEPTORS, WHICH ARE LOCATED AT THE CAROTID BIFURCATION. THESE BARO-RECEPTORS ARE STIMULATED BY THE STRETCH OF INTERVENTIONAL BALLOONS, SDS (STENT DELIVERY SYSTEM) AND DISTAL PROTECTION DEVICES, INITIATING A REFLEX VIA THE GLOSSOPHARYNGEAL NERVE. THIS RESULTS IN A FALL IN BLOOD PRESSURE AND BRADYCARDIA. STENT PLACEMENT MAY PROMOTE PERSISTENT STIMULATION OF THESE BARO-RECEPTORS. THESE REACTIONS ARE ANTICIPATED RELATIVELY SHORT-TERM ADVERSE EVENTS ASSOCIATED WITH THE COMPRESSION OF THE BARO-RECEPTORS DURING BALLOON INFLATION, STENT IMPLANTATION AND FILTER DEVICE MANIPULATION. CERTAIN FACTORS MAY INFLUENCE THE LIKELIHOOD OF ANTICIPATED BARO-RECEPTOR REACTIONS SUCH AS ADVANCED AGE, VENTRICULAR DYSFUNCTION AND GENDER. 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.
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 PER THE CEC THE PATIENT HAD A SECONDARY EVENT, A STROKE, ONE DAY PRIOR TO THE PREVIOUSLY REPORTED TIA EVENT. PTA WAS PERFORMED ON A 70% OCCLUDED LESION IN THE PROXIMAL LEFT INTERNAL CAROTID ARTERY OF 20 MM IN LENGTH IN A 5.8 MM VESSEL DIAMETER WITH MODERATE VESSEL TORTUOSITY. THE ARCH I LESION WAS ECCENTRIC MODERATELY CALCIFIED. AN 8 MM MEDIUM SUPPORT ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS DEPLOYED BEFORE AN 8X40 MM PRECISE PRO RX STENT WAS SUCCESSFULLY DEPLOYED AT THE TARGET SITE. THE ANGIOGUARD WAS SUCCESSFULLY REMOVED AND THERE WAS NO DEBRIS FOUND IN THE BASKET UPON RETRIEVAL. THE RESIDUAL DIAMETER STENOSED MEASURED 20%. THE PATIENT WAS NEUROLOGICALLY INTACT UPON LEAVING THE ANGIO SUITE. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
THE ADJUDICATION MINUTES RECEIVED HAVE ADJUDICATED THE PREVIOUSLY REPORTED TIA AS A CVA - BILATERAL, MINOR, ISCHEMIC/EMBOLIC OCCURRING THE DAY FOLLOWING STENT IMPLANTATION AND THAT THE EVENT WAS PROCEDURE AND DEVICE RELATED. THE (B)(6) FEMALE PATIENT HAD THE FOLLOWING MEDICAL HISTORY: SEVERE PULMONARY DISEASE, HYPERLIPIDEMIA, CLINICAL COPD, CONGESTIVE HEART FAILURE, CORONARY ARTERY DISEASE, CORONARY PERCUTANEOUS REVASCULARIZATION AND HYPERTENSION. THE PATIENT WAS PART OF THE (B)(4) STUDY AND HAD A PRECISE STENT IMPLANTED IN THE LEFT INTERNAL CAROTID ARTERY. TWO DAYS POST INDEX PROCEDURE THE PATIENT HAD A TIA LIKE EPISODE WITH DYSARTHRIA FOR APPROXIMATELY 20 MINUTES, WENT TO THE ER, AND WAS GIVEN PLAVIX, ASPIRIN AND CILOSTAZOL. PATIENT WAS NOT ADMITTED TO THE HOSPITAL AND IS FULLY RECOVERED. 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. 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.
DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE.THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.
ADDITIONAL INFORMATION WAS RECEIVED THAT PER THE CEC THE PATIENT HAD A SECONDARY EVENT, A STROKE, ONE DAY PRIOR TO THE PREVIOUSLY REPORTED TIA EVENT. PTA WAS PERFORMED ON A 70% OCCLUDED LESION IN THE PROXIMAL LEFT INTERNAL CAROTID ARTERY OF 20 MM IN LENGTH IN A 5.8 MM VESSEL DIAMETER WITH MODERATE VESSEL TORTUOSITY. THE ARCH I LESION WAS ECCENTRIC MODERATELY CALCIFIED. AN 8 MM MEDIUM SUPPORT ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS DEPLOYED BEFORE AN 8X40 MM PRECISE PRO RX STENT WAS SUCCESSFULLY DEPLOYED AT THE TARGET SITE. THE ANGIOGUARD WAS SUCCESSFULLY REMOVED AND THERE WAS NO DEBRIS FOUND IN THE BASKET UPON RETRIEVAL. THE RESIDUAL DIAMETER STENOSED MEASURED 20%. THE PATIENT WAS NEUROLOGICALLY INTACT UPON LEAVING THE ANGIO SUITE.
THE (B)(6) FEMALE PATIENT WAS PART OF THE (B)(6) STUDY. THE PATIENT RECEIVED A PRECISE STENT IN THE LEFT INTERNAL CAROTID ARTERY. THE EMAIL RECEIVED FROM THE (B)(6) STUDY INDICATED THAT TWO DAYS POST INDEX PROCEDURE THE PATIENT HAD A TIA LIKE EPISODE WITH DYSARTHRIA FOR APPROXIMATELY 20 MINUTES, WENT TO THE ER, UNDERWENT PLAVIX AND ASA RESPONSIVENESS AND WAS FOUND TO BE NON-RESPONSIVE TO ASA WHICH WAS REPLACED WITH CILOSTAZOL. PATIENT WAS NOT ADMITTED IN THE HOSPITAL. THE PATIENT IS FULLY RECOVERED.
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 | 15036728 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention | ASPIRIN, CLOPIDOGREL |