PRECISE PRO RX CAROTID STENT SYSTEM
Report
- Report Number
- 9616099-2014-00010
- Event Type
- Injury
- Date Received
- January 3, 2014
- Date of Event
- December 12, 2013
- Report Date
- December 12, 2013
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIM
- PMA / PMN Number
- P030047
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
ADDITIONAL INFORMATION WAS REPORTED THAT THERE WAS NONE DOCUMENTED PRESENCE OF AIR BUBBLES. THERE WAS NO OCCLUSION IN THE CONTRALATERAL CAROTID ARTERY. ADDITIONAL LAB VALUES WERE PROVIDED: DATE OF MAXIMUM CK (B)(6) 2013 02:32 AM, MAXIMUM TOTAL CK 142.0, MAXIMUM UPPER LIMIT CK 232.0, DATE OF MAXIMUM CK-MB (B)(6) 2013 02:32 AM, MAXIMUM TOTAL CK-MB 3.7, MAXIMUM UPPER LIMIT CK-MB 6.3, MAXIMUM VALUE UNITS NG/ML. ADDITIONAL INFORMATION ON MEDICATIONS WERE PROVIDED: HEPARIN WAS GIVEN DURING THE PROCEDURE. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED ADVERSE EVENT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2014-00010 AND 1016427-2014-00003.
THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED ADVERSE EVENT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2014-00010 AND 1016427-2014-00003. COMPLAINT CONCLUSION: AS REPORTED BY THE SAPPHIRE REGISTRY, A PATIENT SUFFERED FROM A SUDDEN ONSET OF RIGHT-SIDED HEMIPARESIS AND MILD SLURRING OF SPEECH, WHICH WAS DIAGNOSED AS AN ISCHEMIC STROKE, IMMEDIATELY AFTER AN 8X40MM PRECISE PRO RX STENT WAS DEPLOYED WITH AN ANGIOGUARD IN PLACE. THE PATIENT RECOVERED TO SOME DEGREE AND WAS DISCHARGED TO A REHAB FACILITY 5 DAYS AFTER THE EVENT. THE PATIENT IS A (B)(6) FEMALE WITH A MEDICAL HISTORY OF HYPERLIPIDEMIA, ABNORMAL STRESS TEST, CABG, AORTIC VALVE REPLACEMENT, RENAL INSUFFICIENCY, CORONARY ARTERY DISEASE, AND HISTORY OF TIA AND STROKE. THE TARGET LESION WAS LOCATED IN THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY. THE LESION WAS HEAVILY CALCIFIED IN A CIRCUMFERENTIAL MANNER WITH 75-80% STENOSIS. THE VESSEL WAS DOCUMENTED TO BE TORTUOUS BUT PATENT. THE NIH STROKE SCALE SCORE AT BASELINE WAS 2 FROM RECURRENT TIAS AND RANKIN SCORE IS NOT AVAILABLE. DURING THE CAROTID STENTING PROCEDURE, AN ANGIOGUARD RX EMBOLIC PROTECTION DEVICE WAS DEPLOYED BEHIND THE LESION AND PRE-DILATATION WAS DONE USING A 4X20MM AVIATOR PLUS BALLOON CATHETER. THEN, AN 8X40MM PRECISE PRO RX STENT WAS SUCCESSFULLY IMPLANTED AT THE TARGET LESION. IMMEDIATELY AFTER STENT DEPLOYMENT, THE PATIENT BEGAN TO SUFFER FROM A SUDDEN ONSET OF RIGHT-SIDED HEMIPARESIS WITH THE ANGIOGUARD STILL IN PLACE. THE PATIENT ALSO HAD MILD SLURRING OF SPEECH. A 5X20MM AVIATOR BALLOON CATHETER WAS USED FOR POST-DILATION OF THE PRECISE STENT. THE ANGIOGUARD WAS THEN RETRIEVED, AND IT WAS NOT DOCUMENTED IF THE FILTER HAD DEBRIS IN THE BASKET. THE PATIENT WAS TREATED WITH UNINTERRUPTED ASA AND PLAVIX FOR STENT. CT OF THE HEAD SHOWED ATROPHY AND CHRONIC ISCHEMIC CHANGES. A REPEAT CT SHOWED NO HEMORRHAGE; THE FINAL CT DID DEMONSTRATE EVIDENCE OF EARLY INFARCTION IN THE LEFT FRONTAL LOBE WITH ENCEPHALOMALACIA IN THE LEFT OCCIPITAL LOBE. ALSO SYSTOLIC BLOOD PRESSURE WAS KEPT TO 140-160 DUE TO SMALL VESSEL DISEASE SEEN ON CT. THE PATIENT PARTIALLY RECOVERED BEFORE BEING DISCHARGED TO A REHAB FACILITY 5 DAYS LATER. THE PATIENT HAD IMPROVED SYMPTOMS INCLUDING COMPLETE RESOLUTION OF SPEECH SLURRING AND IMPROVEMENT IN HIS RIGHT UPPER/LOWER EXTREMITY WEAKNESS. THE RIGHT LOWER EXTREMITY HAS VERY MINIMAL WEAKNESS AND HIS UPPER EXTREMITY HAS 4/5 WEAKNESS. THERE WAS NO RANKIN SCORE AVAILABLE AT DISCHARGE, AND THE NIH SCORE IS CURRENTLY UNKNOWN. THE DEVICE WAS IMPLANTED, AND THEREFORE WAS NOT AVAILABLE FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) 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 15870134 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. AN 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. THE DEBRIS MAY ALSO GET CAUGHT IN THE EMBOLIC PROTECTION DEVICE AND OBSTRUCTING THE FLOW. 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. THE SYMPTOMS OF THE STROKE DEPEND ON THE AREA OF THE OXYGEN DEPRIVATION. THE PATIENT MAY HAVE SYMPTOMS SUCH AS VISION CHANGES, CHANGES IN SPEECH, HEMIPARESIS, AND CONFUSION. 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. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE DHR AND THE INFORMATION PROVIDED, THE REPORTED FAILURE/EVENT DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS.
THE CLINICAL EVENTS COMMITTEE (CEC) AGREED THAT A CVA-MAJOR, IPSILATERAL, ISCHEMIC/EMBOLIC OCCURRED AND WAS PROCEDURE AND DEVICE-RELATED. ADDITIONAL DETAILS WERE RECEIVED FROM THE CLINICAL EVENTS COMMITTEE (CEC) MEETING MINUTES : PER PRE-PROCEDURE NOTE FOR PRIOR STROKES STATED: ¿LEFT HIM WITH VISUAL APRAXIA AND DIFFICULTY IN INTERPRETING THE WRITTEN WORD.¿ THERE WERE NO MOTOR DEFICITS, NO VISUAL DEFICITS, AND NO ATAXIA. HE WAS UNABLE TO TELL HIS AGE. THERE WERE NO LANGUAGE DEFICITS. NO DYSARTHRIA. THE NIH STROKE SCALE SCORE WAS 2 DUE TO DISORIENTATION TO AGE, AS WELL AS AN INABILITY TO READ WRITTEN WORD. AFTER STENT DEPLOYMENT, THE PATIENT DEVELOPED NEUROLOGICAL DEFICITS. HE HAD DIFFICULTY MOVING HIS RIGHT UPPER AND LOWER EXTREMITIES, WAS ABLE TO ANSWER QUESTIONS BUT WITH SLURRING OF HIS SPEECH. PER CATHETERIZATION REPORT, THE STENT WAS WIDELY PATENT WITH NORMAL FLOW. THERE WAS NO DISSECTION OR FILLING DEFECT AND NO EVIDENCE OF CUT OFF BRANCHES WITH BRISK FLOW INTO BOTH ANTERIOR AND MIDDLE CEREBRAL BRANCHES. DURING THE PROCEDURE, THERE WERE NO EPISODES OF HYPO- OR HYPERTENSION AND NO NEED FOR BLOOD PRESSURE SUPPORT. THE NEUROLOGICAL SYMPTOMS PROGRESSED AND THE PATIENT HAD 4/5 MOVEMENT OF THE RIGHT UPPER AND LOWER EXTREMITIES. NO DEBRIS WAS FOUND UPON RETRIEVAL OF THE ANGIOGUARD RX ECGW. IMAGES WERE EVALUATED AGAIN, AND THERE WERE NO CHANGES NOTED. IMPRESSION: SUCCESSFUL CAROTID STENTING WITH COMPLICATION OF A CEREBROVASCULAR ACCIDENT SUGGESTIVE OF ATHEROEMBOLIC EVENT. THE SITE REPORTED A 9% FINAL RESIDUAL STENOSIS. THE CONSULTATION NOTE STATED THAT THE PATIENT DEVELOPED POST-PROCEDURAL RIGHT HEMIPARESIS WITH LANGUAGE DYSFUNCTION. THE PATIENT WAS NOT A TPA CANDIDATE DUE TO HEPARIN OVERLOAD PRE-PROCEDURE. POST-PROCEDURE, THE NIH STROKE SCALE SCORE WAS NOT EVALUATED, AS WELL AS IT WAS NOT EVALUATED DURING HIS FURTHER HOSPITAL STAY. PER DISCHARGE SUMMARY, HIS SPEECH DETERIORATED TO SOME APHASIA, HE HAD COMPLETE RESOLUTION OF HIS SPEECH AND HIS RIGHT UPPER AND LOWER EXTREMITIES HAD IMPROVED DRASTICALLY. HIS RIGHT LOWER EXTREMITY HAD VERY MINIMAL WEAKNESS AND HIS RIGHT UPPER AND LOWER EXTREMITY HAD 4/5 WEAKNESS. PRE-DISCHARGE NIH OR RANKIN STROKE SCALE SCORES WERE NOT ASSESSED. THE PATIENT RECEIVED PHYSICAL THERAPY AND WAS TRANSFERRED TO AN ACUTE REHABILITATION FACILITY ON (B)(6) 2013 ON ASA AND CLOPIDOGREL. ADDITIONAL LAB RESULTS/TESTS PROVIDED: A HEAD CT SCAN ON (B)(6) 2013 AT 12:36 SHOWED ATROPHY AND CHRONIC ISCHEMIC CHANGES. A FOLLOW-UP HEAD CT SCAN ON (B)(6) 2013 AT 20:22, COMPARED TO CT SCAN ON (B)(6) 2013 AT 12:36, REVEALED EVIDENCE OF AN EARLY INFARCTION IN THE LEFT FRONTAL LOBE. ENCEPHALOMALACIA IN THE LEFT OCCIPITAL LOBE WAS NOTED. THERE WAS NO HEMORRHAGE NOTED. A FOLLOW-UP HEAD CT SCAN ON (B)(6) 2013 AT 10:20, COMPARED TO PREVIOUS CT SCANS, REVEALED THE FOLLOWING ACCORDING TO RADIOLOGY REPORT IMPRESSION: CHRONIC ISCHEMIC CHANGES AGAIN NOTED WITH MILD HYPOATTENUATION WITHIN THE ANTERIOR LEFT FRONTAL LOBE, AGAIN MOST CONSISTENT WITH AN ACUTE TO SUBACUTE INFARCT IN THE APPROPRIATE CLINICAL SETTING. BASED ON THE ADDITIONAL INFORMATION PROVIDED, (B)(4). UPDATED COMPLAINT CONCLUSION WITH ADJUDICATION MINUTES: AS REPORTED BY THE SAPPHIRE REGISTRY, A PATIENT SUFFERED FROM A SUDDEN ONSET OF RIGHT-SIDED HEMIPARESIS AND MILD SLURRING OF SPEECH, WHICH WAS LATER DIAGNOSED AS A CEREBROVASCULAR ACCIDENT (CVA), IMMEDIATELY AFTER AN 8X40MM PRECISE PRO RX STENT WAS DEPLOYED WITH AN ANGIOGUARD IN PLACE. THE PATIENT RECOVERED TO SOME DEGREE AND WAS DISCHARGED TO A REHAB FACILITY 5 DAYS AFTER THE EVENT. THE PATIENT IS A (B)(6) MALE WITH A MEDICAL HISTORY OF HYPERLIPIDEMIA, ABNORMAL STRESS TEST, CABG, AORTIC VALVE REPLACEMENT, RENAL INSUFFICIENCY, CORONARY ARTERY DISEASE, AND HISTORY OF TIA AND STROKE. THE TARGET LESION WAS LOCATED IN THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY. THE LESION WAS HEAVILY CALCIFIED IN A CIRCUMFERENTIAL MANNER WITH 75-80% STENOSIS. THE VESSEL WAS DOCUMENTED TO BE TORTUOUS BUT PATENT. THE NIH STROKE SCALE SCORE AT BASELINE WAS 2 FROM RECURRENT TIAS AND A PRIOR STROKE WHICH ¿LEFT HIM WITH VISUAL APRAXIA AND DIFFICULTY IN INTERPRETING THE WRITTEN WORD¿ AND DISORIENTATION TO AGE. THE RANKIN SCORE IS NOT AVAILABLE. DURING THE CAROTID STENTING PROCEDURE, AN ANGIOGUARD RX EMBOLIC PROTECTION DEVICE WAS DEPLOYED BEHIND THE LESION AND PRE-DILATATION WAS DONE USING A 4X20MM AVIATOR PLUS BALLOON CATHETER. THEN, AN 8X40MM PRECISE PRO RX STENT WAS SUCCESSFULLY IMPLANTED AT THE TARGET LESION. IMMEDIATELY AFTER STENT DEPLOYMENT, THE PATIENT BEGAN TO SUFFER FROM A SUDDEN ONSET OF RIGHT-SIDED HEMIPARESIS WITH THE ANGIOGUARD STILL IN PLACE. THE PATIENT ALSO HAD MILD SLURRING OF SPEECH. PER CATHETERIZATION REPORT, THE STENT WAS WIDELY PATENT WITH NORMAL FLOW. THERE WAS NO DISSECTION OR FILLING DEFECT AND NO EVIDENCE OF CUT OFF BRANCHES WITH BRISK FLOW INTO BOTH ANTERIOR AND MIDDLE CEREBRAL BRANCHES. DURING THE PROCEDURE, THERE WERE NO EPISODES OF HYPO- OR HYPERTENSION AND NO NEED FOR BLOOD PRESSURE SUPPORT. A 5X20MM AVIATOR BALLOON CATHETER WAS USED FOR POST-DILATION OF THE PRECISE STENT. THE ANGIOGUARD WAS THEN RETRIEVED, AND THERE WAS NO DEBRIS IN THE BASKET. THE SITE REPORTED A 9% FINAL RESIDUAL STENOSIS. THE PATIENT WAS TREATED WITH UNINTERRUPTED ASA AND PLAVIX FOR STENT. CT OF THE HEAD SHOWED ATROPHY AND CHRONIC ISCHEMIC CHANGES. IMPRESSION: SUCCESSFUL CAROTID STENTING WITH COMPLICATION OF A CEREBROVASCULAR ACCIDENT SUGGESTIVE OF ATHEROEMBOLIC EVENT. A REPEAT CT SHOWED NO HEMORRHAGE; THE FINAL CT DID DEMONSTRATE EVIDENCE OF EARLY INFARCTION IN THE LEFT FRONTAL LOBE WITH ENCEPHALOMALACIA IN THE LEFT OCCIPITAL LOBE. ALSO SYSTOLIC BLOOD PRESSURE WAS KEPT TO 140-160 DUE TO SMALL VESSEL DISEASE SEEN ON CT. THE PATIENT PARTIALLY RECOVERED BEFORE BEING DISCHARGED TO A REHAB FACILITY 5 DAYS LATER. THE PATIENT HAD IMPROVED SYMPTOMS INCLUDING COMPLETE RESOLUTION OF SPEECH SLURRING AND IMPROVEMENT IN HIS RIGHT UPPER/LOWER EXTREMITY WEAKNESS. THE RIGHT LOWER EXTREMITY HAS VERY MINIMAL WEAKNESS AND HIS UPPER EXTREMITY HAS 4/5 WEAKNESS. THE NIH AND RANKIN SCORES WERE NOT ASSESS BEFORE DISCHARGE. THE DEVICE WAS IMPLANTED, AND THEREFORE WAS NOT AVAILABLE FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) 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 15870134 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. A 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. THE DEBRIS MAY ALSO GET CAUGHT IN THE EMBOLIC PROTECTION DEVICE AND OBSTRUCTING THE FLOW. 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. THE SYMPTOMS OF THE STROKE DEPEND ON THE AREA OF THE OXYGEN DEPRIVATION. THE PATIENT MAY HAVE SYMPTOMS SUCH AS VISION CHANGES, CHANGES IN SPEECH, HEMIPARESIS, AND CONFUSION. 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. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE DHR AND THE INFORMATION PROVIDED, THE REPORTED FAILURE/EVENT DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS.
THE PRODUCT REMAINS IMPLANTED AND IS THUS NOT AVAILABLE FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THE CATALOG CODE PROVIDED (PXXXRX), REPRESENTS AN UNKNOWN PRECISE STENT. THE CATALOG AND LOT NUMBERS FOR THE ACTUAL PRODUCT USED IN THE PROCEDURE ARE UNKNOWN. CONCOMITANT MEDICATIONS: CARVEDILOL AND AMLODIPINE WERE GIVEN DURING THE PROCEDURE. PRE AND POST-PROCEDURE MEDICATIONS INCLUDED ACETYLSALICYLIC ACID AND CLOPIDOGREL. CONCOMITANT DEVICES: ANGIOGUARD RX EMBOLIC PROTECTION DEVICE. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED ADVERSE EVENT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2014-00010 AND 1016427-2014-00003.
THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED ADVERSE EVENT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2014-00010 AND 1016427-2014-00003.
PLEASE NOTE THAT THE LOT NUMBER AND CATALOG NUMBER FOR THE PRECISE STENT USED IN THIS COMPLAINT HAS BEEN RECEIVED. LOT# 15870134, CATALOG # PC0840RXC. ADDITIONAL INFORMATION: A 5X20MM AVIATOR BALLOON CATHETER WAS USED FOR POST-DILATION OF THE PRECISE STENT. PRE-DILATATION WAS DONE USING A 4X20MM AVIATOR PLUS. ADDITIONAL INFORMATION FOR CONCOMITANT DEVICES: ANGIOGUARD RX EMBOLIC PROTECTION DEVICE, LOT# 70913450, CATALOG #601814RMC; 5X20MM AVIATOR BALLOON CATHETER; AND 4.0MM X 20MM AVIATOR PLUS. THE PRODUCT REMAINS IMPLANTED AND IS THUS NOT AVAILABLE FOR ANALYSIS. A 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. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED ADVERSE EVENT AND THE ASSOCIATED MANUFACTURER REPORT NUMBER IS 1016427-2014-00003.
PLEASE NOTE THAT THE GENDER OF THE PATIENT HAS BEEN CHANGED TO MALE. IT WAS ALSO REPORTED THAT: NIH STROKE SCALE NOT DONE AT TIME OF EVENT NOR IN DAYS POST; ONLY ONCE PATIENT CAME IN FOR 30 DAY FOLLOW-UP WHICH WAS OUTSIDE OF WINDOW. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED ADVERSE EVENT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2014-00010 AND 1016427-2014-00003. COMPLAINT CONCLUSION UPDATED TO INCLUDE THE CORRECTED PATIENT GENDER: AS REPORTED BY THE SAPPHIRE REGISTRY, A PATIENT SUFFERED FROM A SUDDEN ONSET OF RIGHT-SIDED HEMIPARESIS AND MILD SLURRING OF SPEECH, WHICH WAS DIAGNOSED AS AN ISCHEMIC STROKE, IMMEDIATELY AFTER AN 8X40MM PRECISE PRO RX STENT WAS DEPLOYED WITH AN ANGIOGUARD IN PLACE. THE PATIENT RECOVERED TO SOME DEGREE AND WAS DISCHARGED TO A REHAB FACILITY 5 DAYS AFTER THE EVENT. THE PATIENT IS A (B)(6) MALE WITH A MEDICAL HISTORY OF HYPERLIPIDEMIA, ABNORMAL STRESS TEST, CABG, AORTIC VALVE REPLACEMENT, RENAL INSUFFICIENCY, CORONARY ARTERY DISEASE, AND HISTORY OF TIA AND STROKE. THE TARGET LESION WAS LOCATED IN THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY. THE LESION WAS HEAVILY CALCIFIED IN A CIRCUMFERENTIAL MANNER WITH 75-80% STENOSIS. THE VESSEL WAS DOCUMENTED TO BE TORTUOUS BUT PATENT. THE NIH STROKE SCALE SCORE AT BASELINE WAS 2 FROM RECURRENT TIAS AND RANKIN SCORE IS NOT AVAILABLE. DURING THE CAROTID STENTING PROCEDURE, AN ANGIOGUARD RX EMBOLIC PROTECTION DEVICE WAS DEPLOYED BEHIND THE LESION AND PRE-DILATATION WAS DONE USING A 4X20MM AVIATOR PLUS BALLOON CATHETER. THEN, AN 8X40MM PRECISE PRO RX STENT WAS SUCCESSFULLY IMPLANTED AT THE TARGET LESION. IMMEDIATELY AFTER STENT DEPLOYMENT, THE PATIENT BEGAN TO SUFFER FROM A SUDDEN ONSET OF RIGHT-SIDED HEMIPARESIS WITH THE ANGIOGUARD STILL IN PLACE. THE PATIENT ALSO HAD MILD SLURRING OF SPEECH. A 5X20MM AVIATOR BALLOON CATHETER WAS USED FOR POST-DILATION OF THE PRECISE STENT. THE ANGIOGUARD WAS THEN RETRIEVED, AND IT WAS NOT DOCUMENTED IF THE FILTER HAD DEBRIS IN THE BASKET. THE PATIENT WAS TREATED WITH UNINTERRUPTED ASA AND PLAVIX FOR STENT. CT OF THE HEAD SHOWED ATROPHY AND CHRONIC ISCHEMIC CHANGES. A REPEAT CT SHOWED NO HEMORRHAGE; THE FINAL CT DID DEMONSTRATE EVIDENCE OF EARLY INFARCTION IN THE LEFT FRONTAL LOBE WITH ENCEPHALOMALACIA IN THE LEFT OCCIPITAL LOBE. ALSO SYSTOLIC BLOOD PRESSURE WAS KEPT TO 140-160 DUE TO SMALL VESSEL DISEASE SEEN ON CT. THE PATIENT PARTIALLY RECOVERED BEFORE BEING DISCHARGED TO A REHAB FACILITY 5 DAYS LATER. THE PATIENT HAD IMPROVED SYMPTOMS INCLUDING COMPLETE RESOLUTION OF SPEECH SLURRING AND IMPROVEMENT IN HIS RIGHT UPPER/LOWER EXTREMITY WEAKNESS. THE RIGHT LOWER EXTREMITY HAS VERY MINIMAL WEAKNESS AND HIS UPPER EXTREMITY HAS 4/5 WEAKNESS. THERE WAS NO RANKIN SCORE AVAILABLE AT DISCHARGE, AND THE NIH SCORE IS CURRENTLY UNKNOWN. THE DEVICE WAS IMPLANTED, AND THEREFORE WAS NOT AVAILABLE FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) 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 15870134 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. AN 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. THE DEBRIS MAY ALSO GET CAUGHT IN THE EMBOLIC PROTECTION DEVICE AND OBSTRUCTING THE FLOW. 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. THE SYMPTOMS OF THE STROKE DEPEND ON THE AREA OF THE OXYGEN DEPRIVATION. THE PATIENT MAY HAVE SYMPTOMS SUCH AS VISION CHANGES, CHANGES IN SPEECH, HEMIPARESIS, AND CONFUSION. 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. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE DHR AND THE INFORMATION PROVIDED, THE REPORTED FAILURE/EVENT DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS.
AS REPORTED BY THE (B)(4) REGISTRY, A PATIENT SUFFERED FROM A SUDDEN ONSET OF RIGHT-SIDED HEMIPARESIS AND MILD SLURRING OF SPEECH, WHICH WAS DIAGNOSED AS AN ISCHEMIC STROKE, IMMEDIATELY AFTER AN 8X40MM PRECISE PRO RX STENT WAS DEPLOYED WITH AN ANGIOGUARD IN PLACE. THE PATIENT RECOVERED TO SOME DEGREE AND WAS DISCHARGED TO A REHAB FACILITY 5 DAYS AFTER THE EVENT. THE TARGET LESION WAS LOCATED IN THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY. THE LESION WAS HEAVILY CALCIFIED IN A CIRCUMFERENTIAL MANNER WITH 75-80% STENOSIS. THE VESSEL WAS DOCUMENTED TO BE TORTUOUS BUT PATENT. THE NIH STROKE SCALE SCORE AT BASELINE WAS 2 FROM RECURRENT TIAS AND RANKIN SCORE IS NOT AVAILABLE. DURING THE CAROTID STENTING PROCEDURE, AN ANGIOGUARD RX EMBOLIC PROTECTION DEVICE WAS DEPLOYED BEHIND THE LESION. THEN, AN 8X40MM PRECISE PRO RX STENT WAS SUCCESSFULLY IMPLANTED AT THE TARGET LESION. IMMEDIATELY AFTER STENT DEPLOYMENT, THE PATIENT BEGAN TO SUFFER FROM A SUDDEN ONSET OF RIGHT-SIDED HEMIPARESIS WITH THE ANGIOGUARD STILL IN PLACE. THE PATIENT ALSO HAD MILD SLURRING OF SPEECH. THE ANGIOGUARD WAS THEN RETRIEVED, AND IT WAS NOT DOCUMENTED IF THE FILTER HAD DEBRIS IN THE BASKET. THE PATIENT WAS TREATED WITH UNINTERRUPTED ASA AND PLAVIX FOR STENT. ALSO SYSTOLIC BLOOD PRESSURE WAS KEPT TO 140-160 DUE TO SMALL VESSEL DISEASE SEEN ON CT. THE PATIENT PARTIALLY RECOVERED BEFORE BEING DISCHARGED TO A REHAB FACILITY 5 DAYS LATER. THE PATIENT HAD IMPROVED SYMPTOMS INCLUDING COMPLETE RESOLUTION OF SPEECH SLURRING AND IMPROVEMENT IN HIS RIGHT UPPER/LOWER EXTREMITY WEAKNESS. THE RIGHT LOWER EXTREMITY HAS VERY MINIMAL WEAKNESS AND HIS UPPER EXTREMITY HAS 4/5 WEAKNESS. THERE WAS NO RANKIN SCORE AVAILABLE AT DISCHARGE, AND THE NIH SCORE IS CURRENTLY UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 4518 | PRECISE PRO RX CAROTID STENT SYSTEM | SELF EXPANDING STENTS (NIM) | NIM | CORDIS DE MEXICO | NA | 15870134 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Required Intervention| S |