PRECISE PRO RX CAROTID STENT SYSTEM
Report
- Report Number
- 9616099-2013-00216
- Event Type
- Injury
- Date Received
- April 11, 2013
- Date of Event
- March 22, 2013
- Report Date
- March 25, 2013
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIM
- PMA / PMN Number
- P030047
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
ADDITIONAL INFORMATION WAS RECEIVED AND AN ADDITIONAL EVENT WAS REPORTED. IT WAS REPORTED THAT THE PATIENT, EIGHT DAYS POST CAROTID STENT PLACEMENT ((B)(6) 2013) WAS DIAGNOSED WITH A STROKE DUE TO MULTIPLE RIGHT HEMISPHERIC EMBOLIC INFARCTS SECONDARY TO RIGHT ICA THROMBUS AT THE LOCATION OF THE IMPLANTED PRECISE STENT. THE PATIENT RETURNED APPROXIMATELY TWO WEEKS LATER WITH LEFT ARM WEAKNESS. A CT ANGIOGRAM (CTA) WAS PERFORMED AND REVEALED A 65% STENOSIS OF PROXIMAL PORTION OF RIGHT INTERNAL CAROTID ARTERY IMMEDIATELY PROXIMAL TO THE RIGHT ICA STENT. THE (B)(6) PATIENT WHO WAS ENROLLED IN THE (B)(4) HAS HISTORY OF LEFT MIDDLE CEREBRAL ARTERY (MCA) STROKE (2005 AND 2011) AS WELL AS RECENT RIGHT MCA ISCHEMIC STROKE ((B)(6) 2013) DUE TO HIGH GRADE STENOSIS OF THE RIGHT INTERNAL CAROTID ARTERY (ICA) NOW STATUS POST (S/P) RIGHT CAROTID STENT, ATRIAL FIBRILLATION, HYPERTENSION, PANCREATIC CANCER AND LUNG CANCER S/P LOBECTOMY 2010 WHO PRESENTED TO THE HOSPITAL WITH CHIEF COMPLAINT OF LEFT ARM STIFFNESS AND SHAKING. PER PATIENT'S REPORT, THESE SYMPTOMS STARTED THE NIGHT BEFORE ADMISSION. THE PATIENT STATES THAT HE WAS NORMAL WHEN HE WENT TO BED BUT WAS ABNORMAL IN THE MORNING. THE PATIENT STATES THAT HE IS ABLE TO MOVE HIS LEFT ARM WITHOUT DIFFICULTY, BUT FEELS UNCOORDINATED AND SHAKY. THE PATIENT DENIED ANY ISSUES WITH SPEECH, LEG WEAKNESS, OR EATING. NO CHEST PAIN OR SHORTNESS OF BREATH. PATIENT HAS BEEN TAKING ALL OF HIS MEDICATIONS SINCE RECENT DISCHARGE. THE PATIENT WAS RECENTLY HOSPITALIZED FOR STROKE SERVICE EIGHT DAYS AFTER PRECISE CAROTID STENT PLACEMENT DUE TO MULTIPLE RIGHT HEMISPHERIC EMBOLIC INFARCTS SECONDARY TO RIGHT ICA THROMBUS. DURING THIS HOSPITALIZATION, CTA OF THE HEAD AND NECK REVEALED THROMBUS IN HIS RIGHT ICA IN THE AREA OF HIS STENT. ANTICOAGULATION WAS TRANSITIONED FROM TO DALTEPARIN AS HE HAD DEVELOPED THIS THROMBUS WHILE ON DABIGATRAN. THE PATIENT WAS PLANNED FOR DISCHARGE THREE DAYS AFTER BEING ADMITTED FOR A STROKE, BUT BECAME ACUTELY PLEGIC IN HIS LEFT UPPER EXTREMITY JUST BEFORE DISCHARGE. REPEAT CTA DEMONSTRATED INCREASING SIZE OF ICA THROMBUS AND HE WAS STARTED ON HEPARIN. LEFT ARM STRENGTH IMPROVED AND HEMATOLOGY WAS CONSULTED GIVEN WORSENING OF THROMBUS WHILE ON DALTEPARIN. OF NOTE, DURING PRIOR HOSPITALIZATION THE PATIENT HAD A BRIEF EPISODE OF CONFUSION AND RIGHT HAND AUTOMATISMS WHICH WERE CONCERNING FOR POSSIBLE COMPLEX PARTIAL SEIZURE. THIS RESOLVED AFTER SEVERAL MINUTES, CONTINUOUS EEG SHOWED NO EVIDENCE OF SEIZURE. ETIOLOGY OF THIS EPISODE REMAINED UNCLEAR AT DISCHARGE. APPROXIMATELY TWO WEEKS AFTER BEING DISCHARGED THE PATIENT HAD A NEW ONSET OF LEFT ARM STIFFNESS AND UN-COORDINATION. THE PATIENT REPORTED WAKING UP IN THE MORNING WITH AN INABILITY TO CONTROL HIS LEFT ARM. THE PATIENT WAS EVALUATED IN THE EMERGENCY DEPARTMENT AND WAS FELT TO HAVE SUBTLE DYSMETRIA ON THE LEFT. GIVEN HIS COMPLICATED HISTORY, NEURO-IR WAS CONTACTED. THEY RECOMMENDED OBTAINING A CAT SCAN (CT/CTA) TO EVALUATE THE DEGREE OF HIS ICA STENOSIS, ETC. CT AND CTA WERE NEGATIVE FOR ACUTE ISCHEMIA. THE CTA REVEALED A SHORT SEGMENT NARROWING OF THE DISTAL PORTION OF RIGHT COMMON CAROTID ARTERY EXTENDING TO THE PROXIMAL PORTION OF RIGHT INTERNAL CAROTID ARTERY WITH 65% STENOSIS OF PROXIMAL PORTION OF RIGHT INTERNAL CAROTID ARTERY IMMEDIATELY PROXIMAL TO THE RIGHT ICA STENT. THE STENT APPEARED PATENT; THE PROXIMAL PORTION OF THE STENT APPEARED SLIGHTLY FLATTENED, WITHOUT SIGNIFICANT IN-STENT NARROWING. THERE WAS NO APPRECIATED THROMBUS IN HIS R ICA STENT. MRI WAS OBTAINED AND DID NOT REVEAL ANY EVIDENCE OF A NEW ISCHEMIC LESION. NO TREATMENT OF THE RESTENOSIS WAS PERFORMED. THE PATIENT WAS DISCHARGED THE NEXT DAY. THE PRODUCTS WERE NOT RETURNED FOR EVALUATION AND TESTING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE. PATIENTS WHO ARE KNOWN TO BE AT HIGH-RISK FOR RESTENOSIS INCLUDE THOSE WITH DIABETES, LONG LESIONS, SMALL VESSELS, BIFURCATIONS, AND RESTENOTIC LESIONS. STENT THROMBOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. NARROWING OF THE IN-STENT LUMEN AND CESSATION OF ANTIPLATELET THERAPY IN COMBINATION MAY LEAD TO THE FORMATION OF BLOOD CLOT AND THROMBUS FORMATION. THROMBUS FORMATION DECREASES THE AMOUNT OF BLOOD FLOW. REVIEW OF THE INFORMATION SUGGESTS THAT VESSEL, LESION AND PATIENT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THERE POSSIBLE PATIENT FACTORS AND VESSEL/LESION FACTORS THAT MAY HAVE CONTRIBUTED TO THIS PATIENT'S RESTENOTIC EVENT. NEITHER THE DHR NOR THE INFORMATION AVAILABLE FOR REVIEW INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED.
THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
ADDITIONAL INFORMATION WAS RECEIVED AND AN ADDITIONAL EVENT WAS REPORTED. IT WAS REPORTED THAT THE PATIENT, EIGHT DAYS POST CAROTID STENT PLACEMENT ((B)(6) 2013) WAS DIAGNOSED WITH A STROKE DUE TO MULTIPLE RIGHT HEMISPHERIC EMBOLIC INFARCTS SECONDARY TO RIGHT ICA THROMBUS AT THE LOCATION OF THE IMPLANTED PRECISE STENT. THE PATIENT RETURNED APPROXIMATELY TWO WEEKS LATER WITH LEFT ARM WEAKNESS. A CT ANGIOGRAM (CTA) WAS PERFORMED AND REVEALED A 65% STENOSIS OF PROXIMAL PORTION OF RIGHT INTERNAL CAROTID ARTERY IMMEDIATELY PROXIMAL TO THE RIGHT ICA STENT. THE (B)(6) PATIENT WHO WAS ENROLLED DIN THE SAPPHIRE STUDY HAS HISTORY OF LEFT MIDDLE CEREBRAL ARTERY (MCA) STROKE (2005 AND 2011) AS WELL AS RECENT RIGHT MCA ISCHEMIC STROKE ((B)(6) 2013) DUE TO HIGH GRADE STENOSIS OF THE RIGHT INTERNAL CAROTID ARTERY (ICA) NOW STATUS POST (S/P) RIGHT CAROTID STENT, ATRIAL FIBRILLATION, HYPERTENSION, PANCREATIC CANCER AND LUNG CANCER S/P LOBECTOMY 2010 WHO PRESENTED TO THE HOSPITAL WITH CHIEF COMPLAINT OF LEFT ARM STIFFNESS AND SHAKING. PER PATIENT'S REPORT, THESE SYMPTOMS STARTED THE NIGHT BEFORE ADMISSION. THE PATIENT STATES THAT HE WAS NORMAL WHEN HE WENT TO BED BUT WAS ABNORMAL IN THE MORNING. THE PATIENT STATES THAT HE IS ABLE TO MOVE HIS LEFT ARM WITHOUT DIFFICULTY, BUT FEELS UNCOORDINATED AND SHAKY. THE PATIENT DENIED ANY ISSUES WITH SPEECH, LEG WEAKNESS, OR EATING. NO CHEST PAIN OR SHORTNESS OF BREATH. PATIENT HAS BEEN TAKING ALL OF HIS MEDICATIONS SINCE RECENT DISCHARGE. THE PATIENT WAS RECENTLY HOSPITALIZED FOR STROKE SERVICE EIGHT DAYS AFTER PRECISE CAROTID STENT PLACEMENT DUE TO MULTIPLE RIGHT HEMISPHERIC EMBOLIC INFARCTS SECONDARY TO RIGHT ICA THROMBUS. DURING THIS HOSPITALIZATION, CTA OF THE HEAD AND NECK REVEALED THROMBUS IN HIS RIGHT ICA IN THE AREA OF HIS STENT. THE PATIENT WAS EVALUATED AND IT WAS FELT THAT THE RISK OF FURTHER INTRACEREBRAL EMBOLIZATION WOULD OUTWEIGH THE BENEFIT OF ATTEMPTING THROMBECTOMY. ANTICOAGULATION WAS TRANSITIONED FROM TO DALTEPARIN AS HE HAD DEVELOPED THIS THROMBUS WHILE ON DABIGATRAN. THE PATIENT WAS PLANNED FOR DISCHARGE THREE DAYS AFTER BEING ADMITTED FOR A STROKE, BUT BECAME ACUTELY PLEGIC IN HIS LEFT UPPER EXTREMITY JUST BEFORE DISCHARGE. REPEAT CTA DEMONSTRATED INCREASING SIZE OF ICA THROMBUS AND HE WAS STARTED ON HEPARIN. LEFT ARM STRENGTH IMPROVED AND HEMATOLOGY WAS CONSULTED GIVEN WORSENING OF THROMBUS WHILE ON DALTEPARIN. THEY RECOMMENDED STARLING APIXABAN WHICH HE HAS BEEN ON SINCE DISCHARGE. OF NOTE, DURING PRIOR HOSPITALIZATION THE PATIENT HAD A BRIEF EPISODE OF CONFUSION AND RIGHT HAND AUTOMATISMS WHICH WERE CONCERNING FOR POSSIBLE COMPLEX PARTIAL SEIZURE. THIS RESOLVED AFTER SEVERAL MINUTES WITH NO PAST-ICTAL PERIOD, CONTINUOUS EEG SHOWED NO EVIDENCE OF SEIZURE. ETIOLOGY OF THIS EPISODE REMAINED UNCLEAR AT DISCHARGE. APPROXIMATELY TWO WEEKS AFTER BEING DISCHARGED THE PATIENT HAD A NEW ONSET OF LEFT ARM STIFFNESS AND UN-COORDINATION. THE PATIENT REPORTED WAKING UP IN THE MORNING WITH AN INABILITY TO CONTROL HIS LEFT ARM. THE PATIENT WAS EVALUATED IN THE EMERGENCY DEPARTMENT AND WAS FELT TO HAVE SUBTLE DYSMETRIA ON THE LEFT. GIVEN HIS COMPLICATED HISTORY, NEURO-IR WAS CONTACTED. THEY RECOMMENDED OBTAINING A CAT SCAN (CT/CTA) TO EVALUATE THE DEGREE OF HIS ICA STENOSIS, ETC. CT AND CTA WERE NEGATIVE FOR ACUTE ISCHEMIA. THE CTA REVEALED A SHORT SEGMENT NARROWING OF THE DISTAL PORTION OF RIGHT COMMON CAROTID ARTERY EXTENDING TO THE PROXIMAL PORTION OF RIGHT INTERNAL CAROTID ARTERY WITH 65% STENOSIS OF PROXIMAL PORTION OF RIGHT INTERNAL CAROTID ARTERY IMMEDIATELY PROXIMAL TO THE RIGHT ICA STENT. THE STENT APPEARED PATENT; THE PROXIMAL PORTION OF THE STENT APPEARED SLIGHTLY FLATTENED, WITHOUT SIGNIFICANT IN-STENT NARROWING. THERE WAS NO APPRECIATED THROMBUS IN HIS R ICA STENT. MRI WAS OBTAINED AND DID NOT REVEAL ANY EVIDENCE OF A NEW ISCHEMIC LESION. NO TREATMENT OF THE RESTENOSIS WAS PERFORMED. THE PATIENT WAS DISCHARGED THE NEXT DAY. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
AS REPORTED, THE (B)(4) STUDY INDICATED THAT NINE DAYS POST INDEX PROCEDURE THE PATIENT EXPERIENCED THE EVENT OF ISCHEMIC STROKE. THE TARGET LESION LOCATION WAS THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY. AN ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS DEPLOYED DISTAL TO THE LESION AND THE LESION WAS PRE-DILATED. A PRECISE STENT WAS OPENED BUT THE OPERATOR CHANGED HIS MIND REGARDING AN APPROPRIATE STENT SIZE AFTER THEY HAD OPENED, SO IT WAS NOT EVER DEPLOYED IN THE PATIENT. ANOTHER PRECISE WAS OPENED AND DEPLOYED IN THE TARGET LESION. THE ANGIOGUARD WAS REMOVED FROM THE PATIENT AND UPON REMOVAL THERE WAS NO DEBRIS FOUND IN THE BASKET. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS DISCHARGED THE NEXT DAY WITH ASPIRIN PRESCRIBED. APPROXIMATELY NINE DAYS POST PROCEDURE THE PATIENT SUFFERED A NEUROLOGICAL EVENT DESCRIBED AS REFLEX CHANGE, AND HEMIPARESIS ON THE LEFT SIDE. THE ONSET WAS SUDDEN AND RECOVERY IS UNKNOWN. THE PATIENT WAS DIAGNOSED WITH AN ISCHEMIC STROKE. THE EVENT WAS EVALUATED AND DETERMINED TO BE UNRELATED TO THE CORDIS PRODUCT BUT RELATED TO THE INDEX PROCEDURE. THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND TESTING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. ISCHEMIC STROKE 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. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.
AS REPORTED, THE (B)(4) STUDY INDICATED THAT NINE DAYS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED THE EVENT OF ISCHEMIC STROKE. THE PATIENT IS (B)(6) MALE. THE TARGET LESION LOCATION WAS THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY. THE LESION WAS DESCRIBED AS ECCENTRIC AND ULCERATED. THE VESSEL WAS DESCRIBED AS MODERATELY CALCIFIED AND MILDLY TORTUOUS. THE RATE OF STENOSIS WAS 75%. AN ANGIOGUARD (501814RMC/LOT 70912414) EMBOLIC PROTECTION DEVICE WAS DEPLOYED DISTAL TO THE LESION AND THE LESION WAS PRE-DILATED. A PRECISE (PC1030RXC/ LOT 15526146) STENT WAS OPENED BUT THE OPERATOR CHANGED HIS MIND REGARDING AN APPROPRIATE STENT SIZE AFTER THEY HAD OPENED, SO IT WAS NOT EVER DEPLOYED IN THE PATIENT. ANOTHER PRECISE (PC0820RXC/ LOT 15761258) WAS OPENED AND DEPLOYED IN THE TARGET LESION. THE ANGIOGUARD WAS REMOVED FROM THE PATIENT AND UPON REMOVAL, THERE WAS NO DEBRIS FOUND IN THE BASKET. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS NEUROLOGICALLY INTACT WHEN TAKEN FROM THE ANGIO SUITE. THE PATIENT WAS DISCHARGED THE NEXT DAY WITH ASPIRIN PRESCRIBED. APPROXIMATELY, NINE DAYS POST PROCEDURE, THE PATIENT SUFFERED A NEUROLOGICAL EVENT DESCRIBED AS REFLEX CHANGE, AND HEMIPARESIS ON THE LEFT SIDE. THE ONSET WAS SUDDEN AND RECOVERY IS UNKNOWN. THE PATIENT WAS DIAGNOSED WITH AN ISCHEMIC STROKE. THE EVENT WAS EVALUATED AND DETERMINED TO BE UNRELATED TO THE CORDIS PRODUCT BUT RELATED TO THE INDEX PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 155938 | PRECISE PRO RX CAROTID STENT SYSTEM | SELF EXPANDING STENTS (NIM) | NIM | CORDIS DE MEXICO | NA | 15761258 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Hospitalization| L| R | ANGIOGUARD |