PRECISE PRO RX CAROTID STENT SYSTEM
Report
- Report Number
- 9616099-2011-00060
- Event Type
- Injury
- Date Received
- January 28, 2011
- Date of Event
- November 10, 2010
- Report Date
- January 3, 2011
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIM
- PMA / PMN Number
- P030047
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
Narratives
THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1016427-2011-00012 AND 9616099-2011-00060. NO MALFUNCTION OCCURRED WITH THE ANGIOGUARD RX. THE PATIENT DID NOT HAVE ANY KNOWN ALLERGIES TO NITINOL, NICKEL, OR TITANIUM. A 6FR SHUTTLE SHEATH INTRODUCER WAS USED. THERE WAS A TIGHT SEAL BETWEEN THE STENT DELIVERY SYSTEM 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 NOTED POST-DEPLOYMENT. THE TIA OCCURRED ON THE LEFT SIDE OF THE BRAIN.
THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1016427-2011-00012 AND 9616099-2011-00060. THE COMPLAINT RECEIVED STATES THAT DURING THE INDEX PROCEDURE, THIS (B)(4) STUDY PATIENT EXPERIENCED HYPOTENSION AND FOLLOWING THE PROCEDURE SUFFERED A TIA (TRANSIENT ISCHEMIC ATTACK). THIS IS A (B)(6) MALE WITH MEDICAL HISTORY INCLUDING TRANSIENT ISCHEMIC ATTACK, HYPERLIPIDEMIA, CORONARY ARTERY DISEASE, CORONARY PERCUTANEOUS REVASCULARIZATION, AND HYPERTENSION. THIS PATIENT MEETS THE HIGH-RISK CRITERIA OF AGE GREATER THAN 75 YEARS. THE TARGET LESION WAS LOCATED IN THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY (ICA). THE LESION WAS DESCRIBED AS 80% STENOSED, 10MM IN LENGTH, CONCENTRIC, ECCENTRIC, NON-THROMBOSED, WITH MILD CALCIFICATION. THE REFERENCE VESSEL WAS 6.0MM IN DIAMETER. AN ANGIOGUARD WAS INSERTED, ADVANCED AND DEPLOYED PAST THE TARGET LESION WITHOUT REPORT OF DIFFICULTY. ONE PRECISE PRO RX 9 X 40MM STENT WAS DEPLOYED WITHOUT REPORT OF DIFFICULTIES. NO DISSECTION WAS REPORTED. AND NO THROMBUS WAS NOTED AT THE TARGET SITE. THE ANGIOGUARD WAS RETRIEVED WITH DEBRIS NOTED IN THE BASKET. RESIDUAL STENOSIS WAS 10%. POST STENT DEPLOYMENT THE PATIENT HAD SIGNIFICANT DECREASE IN BLOOD PRESSURE. THE BLOOD PRESSURE DROPPED FROM 160 TO 110 AND NEO-SYNEPHRINE WAS GIVEN. THE STUDY COORDINATOR CONFIRMED THE ANGIOGUARD RX WAS IN PLACE AT THE TIME THE SYSTOLIC BLOOD PRESSURE DROPPED. THE BLOOD PRESSURE REGAINED PRE-PROCEDURE LEVELS WITH MEDICAL TREATMENT. THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITH NO NEUROLOGICAL DEFICIT. AFTER THE PATIENT LEFT THE ANGIO SUITE, HE EXPERIENCED APHASIA AND WAS DIAGNOSED WITH TRANSIENT ISCHEMIC ATTACK (TIA). THERE WAS NO VISUAL FIELD LOSS, HEMIPARESIS, HEMINEGLECT, OR HEMIATAXIA. A STAT NEUROLOGY EVALUATION WAS REQUESTED; HOWEVER, NO TREATMENT WAS GIVEN FOR THE TIA AS THE SYMPTOMS RESOLVED. THE EVENT LASTED LESS THAN TWENTY-FOUR HOURS AND FULLY RESOLVED WITH NO DEFICIT. THE STENT REMAINS IMPLANTED AND THE ANGIOGUARD WAS DISCARDED, THUS NEITHER PRODUCT IS AVAILABLE FOR ANALYSIS. (B)(4): THERE IS NO STERILE LOT NUMBER INFORMATION AVAILABLE THUS NO DHR COULD BE PERFORMED. (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 15223125 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 AND EXCURSIONS WERE ISSUED FOR THIS LOT. HYPOTENSION IS A WELL-KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE. 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. CLINICAL RESEARCH HAS REVEALED THAT 40% OF PATIENTS UNDERGOING CAROTID ARTERY STENTING (CAS) SUSTAINED A REACTION SECONDARY TO CAROTID BODY STIMULATION DURING BALLOON INFLATION, MOST COMMONLY SHORT-TERM HYPOTENSION WITHOUT CLINICAL SYMPTOMS, NOT ASSOCIATED TO PERIPROCEDURAL CEREBRAL COMPLICATIONS. APHASIA, AS A SYMPTOM OF TIA, IS A WELL-KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE. 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 TRAVEL UPSTREAM TO THE CEREBRAL ARTERIES POTENTIALLY DISRUPTING PERFUSION. 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 VESSEL, LESION AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS.
AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED A TRANSIENT ISCHEMIC ATTACK. FOLLOWING STENT DEPLOYMENT, THE PATIENT'S SYSTOLIC BLOOD PRESSURE DROPPED FROM 160 TO 110 AND NEO-SYNEPHRINE WAS GIVEN. THE TARGET LESION WAS LOCATED IN THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY (ICA). THE LESION WAS DESCRIBED AS 80% STENOSED, 10MM IN LENGTH, CONCENTRIC, ECCENTRIC, NON-THROMBOSED, WITH MILD CALCIFICATION. THE REFERENCE VESSEL WAS 6.0MM IN DIAMETER. A 6MM ANGIOGUARD RX WAS SUCCESSFULLY DEPLOYED BEYOND THE TARGET LESION. THE LESION WAS PRE-DILATED AND A 9X40MM PRECISE PRO RX STENT WAS SUCCESSFULLY IMPLANTED. NO DISSECTION OCCURRED DURING THE PROCEDURE. THE ANGIOGUARD WAS RETRIEVED WITH DEBRIS NOTED IN THE BASKET. RESIDUAL STENOSIS WAS 10%. THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITH NO NEUROLOGICAL DEFICIT. THERE WERE NO AIR BUBBLES PRESENT DURING THE PROCEDURE. THE PATIENT WAS ASYMPTOMATIC PRIOR TO THE PROCEDURE. THERE WERE NO TECHNICAL PROBLEMS WITH THE PRECISE PRO RX STENT OR THE ANGIOGUARD RX. FOLLOWING STENT DEPLOYMENT , THE PATIENT'S SYSTOLIC BLOOD PRESSURE DROPPED FROM 160 TO 110 AND NEO-SYNEPHRINE WAS GIVEN. THE STUDY COORDINATOR CONFIRMED THE ANGIOGUARD RX WAS IN PLACE AT THE TIME THE SYSTOLIC BLOOD PRESSURE DROPPED. AFTER THE PROCEDURE, THE PATIENT EXPERIENCED APHASIA AND WAS DIAGNOSED WITH TRANSIENT ISCHEMIC ATTACK (TIA). THERE WAS NO VISUAL FIELD LOSS, HEMIPARESIS, HEMINEGLECT, OR HEMIATAXIA. A STAT NEUROLOGY EVALUATION WAS REQUESTED; HOWEVER, NO TREATMENT WAS GIVEN FOR THE TIA AS THE SYMPTOMS RESOLVED. THE EVENT LASTED LESS THAN TWENTY-FOUR HOURS AND FULLY RESOLVED WITH NO DEFICIT. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO CORDIS PRODUCT. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS RELATED TO THE INDEX PROCEDURE. THE LESION WAS NOT PRE-DILATED; HOWEVER, THE LESION WAS POST-DILATED WITH A NON-CORDIS BALLOON CATHETER. THE ANGIOGUARD RX LOT NUMBER WAS UNKNOWN.
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 | 15223125 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Required Intervention | 6MM ANGIOGUARD RX |