PRECISE PRO RX CAROTID STENT SYSTEM
Report
- Report Number
- 9616099-2013-00433
- Event Type
- Injury
- Date Received
- July 9, 2013
- Date of Event
- May 18, 2013
- Report Date
- June 17, 2013
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIM
- PMA / PMN Number
- P030047
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
THE ADJUDICATION MINUTES FOR THIS SAPPHIRE STUDY PATIENT WERE RECEIVED AND REVIEWED. AFTER REVIEW, THERE IS NO CHANGE TO THE REPORTED EVENTS OF ISCHEMIC STROKE AND HYPOTENSION AS CAPTURED. NO CHANGE TO THE COMPLAINT CONCLUSION. THE COMMITTEE¿S FINDINGS INDICATED THAT: CVA - MINOR, IPSILATERAL, ISCHEMIC/EMBOLIC WAS PROCEDURE-RELATED/DEVICE-RELATED-AGREE; AND CVA - MINOR, NON-IPSILATERAL, ISCHEMIC/EMBOLIC PROCEDURE-RELATED/DEVICE-RELATED-AGREE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT: PRE-PROCEDURE THE NIH STROKE SCALE SCORE WAS 0 AND THE RANKIN SCORE WAS 0. THE PATIENT UNDERWENT THE INDEX PROCEDURE WITH DELIVERY OF THE ANGIOGUARD¿ RX ECGW, PRE-STENT BALLOON ANGIOPLASTY AND PLACEMENT OF ONE PRECISE® PRO RX STENT IN THE RIGHT OSTIAL ICA. UPON RETRIEVAL OF THE ANGIOGUARD¿ THERE WAS NO DEBRIS SEEN IN THE FILTER. THE SITE REPORTED A 10% FINAL RESIDUAL STENOSIS. THE PROCEDURE ENDED AND THE PATIENT WAS TRANSFERRED TO THE CORONARY CARE UNIT AFTER EXPERIENCING PROCEDURAL HYPOTENSION DURING THE CAROTID STENTING, WHICH REQUIRED PRESSORS. THIS WAS THOUGHT TO BE DUE TO IRRITATION OF THE CAROTID BODY DURING THE PROCEDURE IN ADDITION TO ADMINISTRATION OF BLOOD PRESSURE-LOWERING MEDICATIONS DURING THE PROCEDURE. METOPROLOL AND ISOSORBIDE MONONITRATE WERE HELD SECONDARY TO THE HYPOTENSION AND WOULD BE RESUMED AFTER A MEETING WITH THE PRIMARY CARE PHYSICIAN. POST-PROCEDURE, AT AN UNKNOWN TIME, THE STROKE SCALE SCORES WERE EVALUATED BY A DIFFERENT EXAMINER. THE NIH STROKE SCALE SCORE WAS 0 AND THE RANKIN SCORE WAS 0. THE NEXT MORNING, THE PATIENT WAS NOTED TO HAVE SIGNIFICANT GAIT INSTABILITY/ATAXIA, INCREASED FROM BASELINE. THE SITE REPORTED THAT THE PATIENT HAD AN ISCHEMIC STROKE. PHYSICAL MEDICINE WAS CONSULTED AND RECOMMENDED 24-HOUR ASSISTANCE FOR GAIT AND TRANSFERS. A HEAD CT WITHOUT CONTRAST REVEALED THE FOLLOWING: SMALL ROUND HYPODENSITY IN THE RIGHT CENTRUM OVALE LIKELY REPRESENTS SMALL VESSEL ISCHEMIC CHANGES. PATCHY LOW DENSITY CHANGES THROUGHOUT THE WHITE MATTER LIKELY DUE TO LEUKOARAIOSIS. NO HEMORRHAGE, HYDROCEPHALUS OR MASS EFFECT. NORMAL SOFT TISSUE SWELLING. THE PARANASAL SINUSES AND MASTOID CELLS ARE WELL AERATED. NEUROLOGY WAS CONSULTED AND RECOMMENDED A MRI. TWO DAYS AFTER THE PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN AT REST CONSISTENT WITH UNSTABLE ANGINA WHICH RESOLVED WITH ADMINISTRATION OF NITROGLYCERIN. THE ECG REVEALED INCREASED T WAVE INVERSIONS IN LEADS V1-V3; "TROPONINS WERE WITHOUT SIGNIFICANT DELTA." A TRANSESOPHAGEAL ECHOCARDIOGRAM SHOWED NO CHANGE FROM 2009 AND THERE WAS NO EVIDENCE OF THROMBUS. MEDICAL MANAGEMENT OF HIS CARDIOVASCULAR DISEASE WAS RECOMMENDED AND HIS HOME MEDICATION REGIMEN WAS RESUMED. A CARDIAC CATHETERIZATION WAS NOT INDICATED. A MRI WAS COMPARED TO A 2011 MRI AND REVEALED THE FOLLOWING: MULTIPLE INTERVAL RIGHT-SIDED ACUTE INFARCTIONS LOCATED IN THE FRONTAL, PARIETAL, OCCIPITAL LOBES IN CORTICAL, SUBCORTICAL WHITE MATTER, DEEP WHITE MATTER LOCATIONS. SINGLE LEFT OCCIPITAL SUBCORTICAL AND LEFT CENTRUM SEMIOVALE WHITE MATTER INTERVAL ACUTE INFARCTIONS. NO INFARCTIONS WITHIN THE POSTERIOR FOSSA. SUPERIMPOSED MODERATE TO MARKED LEUKOARAIOSIS. DOMINANT RIGHT VERTEBRAL ARTERY, NORMAL VARIANT. OTHERWISE NEGATIVE. SPECIFICALLY, NO MASS EFFECT/MIDLINE SHIFT. NORMAL SIZED VENTRICLES. THE PATIENT WAS EVALUATED FOR HOME SAFETY. AS LONG AS HE USED A WALKER AND WAS SUPERVISED OR ASSISTED WITH SOME ACTIVITIES, HE COULD RETURN TO HOME. CONTINUED SMOKING CESSATION WAS RECOMMENDED. THE DISCHARGE SUMMARY DOCUMENTED THE PRIMARY DISCHARGE DIAGNOSIS AS ATAXIA, ACUTE AND CHRONIC WITH PERTINENT ADDITIONAL DIAGNOSES, INCLUDING BUT NOT LIMITED TO, ACUTE CRYPTOGENIC STROKE (B)(6) 2013 WITHOUT SEQUELAE AND UNSTABLE ANGINA. THE PATIENT WAS DISCHARGED FIVE DAYS AFTER THE PROCEDURE TO HOME ON ASA AND CLOPIDOGREL. RESUMING METOPROLOL AND ISOSORBIDE MONONITRATE WOULD BE DETERMINED AT A PRIMARY CARE PHYSICIAN VISIT. THE 30-DAY FOLLOW-UP VISIT WAS COMPLETED. THE STROKE SCALE SCORES WERE NOT EVALUATED. THE PATIENT WAS TAKING ASA AND CLOPIDOGREL.
THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT EXPERIENCED HYPOTENSION DURING THE INDEX PROCEDURE THAT REQUIRED PRESSOR SUPPORT. THE DAY AFTER THE STUDY INDEX PROCEDURE FOR CAROTID STENT IMPLANTATION, THE PATIENT EXPERIENCED AN ADVERSE EVENT (AE) OF ISCHEMIC STROKE. THE ONSET OF THE EVENT WAS SUDDEN. THE NEUROLOGICAL DEFICIT OPTIONS WERE REPORTED AS ¿OTHER¿. THE PATIENT WAS NOTED TO HAVE SIGNIFICANT GAIT INSTABILITY/ATAXIA, INCREASED FROM THE BASELINE. THE EVENT WAS REPORTED TO BE UNRELATED TO A CORDIS DEVICE OR ANTICOAGULATION AND WAS RELATED TO THE INDEX PROCEDURE. THE PATIENT RECOVERY WAS FULL WITH NO RESIDUALS. NO INTERVENTION/EMERGENCY CEA SURGERY WAS PERFORMED. THE TARGET LESION FOR THE PROCEDURE WAS THE OSTIAL LEFT INTERNAL CAROTID ARTERY (LICA). A 7 MM. ANGIOGUARD WAS USED FOR THE PROCEDURE. THE TARGET LESION WAS REPORTED TO BE: AN 80% STENOSIS, 20 MM. IN LENGTH, ABSENT OF THROMBUS, 8 MM. REFERENCE DIAMETER, SEVERELY CALCIFIED, MILDLY TORTUOUS, AND ECCENTRIC. THE LESION WAS PRE-DILATED. THE RESIDUAL STENOSIS WAS 10%. THE PATIENT WAS DISCHARGED FIVE DAYS AFTER THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT ALSO EXPERIENCED HYPOTENSION DURING THE INDEX PROCEDURE THAT REQUIRED PRESSOR SUPPORT. THE HYPOTENSION WAS THOUGHT TO BE SECONDARY TO IRRITATION OF THE CAROTID BODY DURING THE PROCEDURE IN COMBINATION WITH BLOOD PRESSURE LOWERING MEDICATION ADMINISTERED DURING THE PROCEDURE. A MRI OF THE HEAD DEMONSTRATED TWO NEW SMALL STROKES IN THE POSTERIOR CIRCULATION. THE DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR INSPECTION. 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 15627246 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. ISCHEMIC STROKE/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. HYPOTENSION AND BRADYCARDIA RELATED TO CAROTID STENTING IS USUALLY RELATED TO BARO-RECEPTOR STIMULATION. BARORECEPTORS DETECT THE AMOUNT OF STRETCH OF THE BLOOD VESSEL WALLS, AND SEND THE SIGNAL TO THE NERVOUS SYSTEM IN RESPONSE TO THIS STRETCH, 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. THERE IS NO EVIDENCE THAT MANUFACTURING ISSUES CONTRIBUTED TO THE EVENT. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT FACTORS OF PAROXYSMAL ATRIAL FIBRILLATION AND PROCEDURE HYPOTENSION, VESSEL AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS.
THE REPORT RECEIVED FROM THE (B)(6) STUDY INDICATED THAT THE PATIENT WAS ENROLLED IN THE STUDY AND HAD A PRECISE 8 X 40 STENT SUCCESSFULLY IMPLANTED IN THE OSTIAL LEFT INTERNAL CAROTID ARTERY (LICA) DURING THE STUDY INDEX PROCEDURE. THE PATIENT HAD NO NEUROLOGICAL DEFICIT UPON LEAVING THE ANGIOGRAPHY SUITE POST-PROCEDURE. THE DAY AFTER THE STUDY INDEX PROCEDURE FOR CAROTID STENT IMPLANTATION, THE PATIENT EXPERIENCED AN ADVERSE EVENT (AE) OF ISCHEMIC STROKE. THE ONSET OF THE EVENT WAS SUDDEN. THE NEUROLOGICAL DEFICIT OPTIONS WERE REPORTED AS ¿OTHER¿. THE EVENT WAS REPORTED TO BE UNRELATED TO A CORDIS DEVICE OR ANTICOAGULATION AND WAS RELATED TO THE INDEX PROCEDURE. THE PATIENT RECOVERY WAS FULL WITH NO RESIDUALS. NO INTERVENTION/EMERGENCY CEA SURGERY WAS PERFORMED. THE TARGET LESION FOR THE PROCEDURE WAS THE OSTIAL LEFT INTERNAL CAROTID ARTERY (LICA). A 7 MM. ANGIOGUARD WAS USED FOR THE PROCEDURE. THE TARGET LESION WAS REPORTED TO BE: AN 80% STENOSIS, 20 MM. IN LENGTH, ABSENT OF THROMBUS, 8 MM. REFERENCE DIAMETER, SEVERELY CALCIFIED, MILDLY TORTUOUS, AND ECCENTRIC. THE LESION WAS PRE-DILATED. THE RESIDUAL STENOSIS WAS 10%. THE PATIENT WAS DISCHARGED FIVE DAYS AFTER THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313127 | PRECISE PRO RX CAROTID STENT SYSTEM | SELF EXPANDING STENTS (NIM) | NIM | CORDIS DE MEXICO | NA | 15627246 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Life Threatening | 7 MM. ANGIOGUARD |