PRECISE PRO RX CAROTID STENT SYSTEM
Report
- Report Number
- 9616099-2013-00245
- Event Type
- Injury
- Date Received
- April 23, 2013
- Date of Event
- January 7, 2013
- Report Date
- March 29, 2013
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIM
- PMA / PMN Number
- P030047
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- Reporter Occupation
- OTHER
Narratives
ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT EXPIRED DUE TO COMPLICATIONS OF PNEUMONIA AND ACUTE RENAL FAILURE. THERE WERE NO AIR BUBBLES PRESENT DURING THE INDEX PROCEDURE. THE PATIENT WAS ANTICOAGULATED. THE SYMPTOMS BEGAN APPROXIMATELY 10 HOURS POST PROCEDURE. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THIS EVENT NO LONGER MEETS THAT CRITERIA FOR REPORTING AS A SERIOUS INJURY UNDER MDR REGULATIONS. PLEASE UPDATE YOUR FILES ACCORDINGLY.
ADDITIONAL INFORMATION RECEIVED: BASED ON THE ADJUDICATION MINUTES AND ACCORDING TO CATHETERIZATION REPORT, THE PATIENT DEVELOPED TRANSIENT CONFUSION, WHICH RESOLVED AT THE END OF THE PROCEDURE. HE WAS ALERT, ORIENTED AND HAD NO NEUROLOGICAL DEFICITS. THE PROCEDURE WAS ALSO REMARKABLE FOR SINUS BRADYCARDIA IN HIGH 30S - LOW 40S, TREATED WITH ATROPINE WITH HEART RATE STAYING AT 60S. OPERATOR ALSO NOTED A DROP IN BLOOD PRESSURE FORM 220 MMHG SYSTOLIC TO ABOUT 140 MMHG AT THE END OF THE PROCEDURE. THE PATIENT WAS TRANSFERRED TO THE HOLDING AREA IN STABLE CONDITION. ON (B)(6) 2013 AT 21:30, THE PATIENT DEVELOPED APHASIA WITH PROGRESSIVELY INCREASING BLOOD PRESSURE. THIS WAS FOLLOWED BY GENERALIZED TONIC SEIZURE ACTIVITY. A STROKE ALERT WAS CALLED. THE PATIENT WAS TRANSFERRED TO ICU AND INTUBATED FOR AIRWAY PROTECTION. IV KEPPRA LOADING DOSE WAS GIVEN, AFTER WHICH NO OVERT SEIZURES WERE OBSERVED. PER NEUROLOGY CONSULTATION NOTE ON (B)(6) 2013, THE PATIENT HAD REMAINED VERY AGITATED AND APHASIC SINCE THIS EVENT, AND REQUIRED USE OF SEDATING AGENTS OVERNIGHT "TO MAINTAIN VENTILATORY STATUS." PER NEUROLOGICAL EXAM DESCRIPTION, THE PATIENT WAS UNRESPONSIVE AND SEDATED. CRANIAL NERVE EXAMINATION REVEALED THAT GAZE WAS AT MIDLINE, THE PUPILS WERE 2 MM IN SIZE AND REACTIVE. A DOLL'S EYE RESPONSE WAS PRESENT. A GAG RESPONSE WAS PRESENT. REMAINDER OF CRANIAL NERVE TESTING REVEALED NO ABNORMALITIES, BUT WAS LIMITED DUE TO PATIENT'S SEDATION. TONE WAS MAINTAINED IN THE EXTREMITIES. WITH NOXIOUS STIMULUS, HE DID WITHDRAW ALL THE EXTREMITIES, THE RIGHT ARM PERHAPS WITH LESS MOVEMENT RELATIVE TO THE LEFT, BUT THERE WAS APPROPRIATE WITHDRAWAL RESPONSE SEEN. NO ABNORMAL POSTURING OR EXTENSOR MOVEMENT. SENSORY EXAM NOTED RESPONSE TO NOXIOUS STIMULI. TESTING APPEARED TO BE ROUGHLY SYMMETRICAL BUT DID REQUIRE DEEP STIMULATION TO GET A RESPONSE. THERE WAS ALSO HAD A FACIAL GRIMACE WITH NOXIOUS STIMULUS BUT HE DID NOT OPEN HIS EYES. NEUROLOGY CONSULTATION IMPRESSION: REPERFUSION SYNDROME WITH DIFFERENTIAL DIAGNOSIS TO INCLUDE EMBOLIC EVENTS FROM THE CAROTID STENT AND ISCHEMIC STROKE. A HEAD CT SCAN ON (B)(6) 2013 REVEALED THE FOLLOWING, ACCORDING TO RADIOLOGY REPORT IMPRESSION: 1) NO ACUTE INTRACRANIAL HEMORRHAGE OR DEFINITE MASS EFFECT; 2) QUESTIONABLE SMALL HYPODENSITY IN THE ANTERIOR RIGHT PONS. FOR THE RECORD, ON (B)(6) 2013 AT 05:00, THE CK WAS 303 (NL 174, RATIO) AND THE CKMB WAS 4.7 (NL 6.3, RATIO <1). TROPONIN WAS 0.13. NO FURTHER CARDIAC ENZYME DRAWS WERE DONE. ON (B)(6) 2013, THE BNP WAS 1226. AN EEG ON (B)(6) 2013 REVEALED THE FOLLOWING, ACCORDING TO REPORTED IMPRESSION: ABNORMAL EEG NOTING A MILD SUPPRESSION OF BACKGROUND ACTIVITY, SUGGESTIVE OF A MILD ENCEPHALOPATHY; THE PATIENT ON IV SEDATION WHICH MAY BE A CONTRIBUTOR FACTOR. NO SIDE-TO-SIDE ASYMMETRY SEEN. NO EPILEPTIFORM ACTIVITY SEEN. BILATERAL CAROTID ULTRASOUND ON (B)(6) 2013 AT 04:15 REVEALED LEFT ICA STENT, MAXIMAL ICA VELOCITY 194 CM/SEC; ICA/CCA RATIO 2.3, AND A PATENT CCA. IMPRESSION: A 50-69% STENOSIS OF THE LEFT ICA. FOR THE RIGHT CAROTID ARTERY, THERE WAS A 50-69% STENOSIS IN THE RIGHT ICA AND A PATENT CCA. ANTEGRADE FLOW IN THE VERTEBRAL ARTERIES WAS NOTED. A FOLLOW-UP HEAD CT SCAN ON (B)(6) 2013 REPORTED NO SIGNIFICANT HEAD CT ABNORMALITY IDENTIFIED, NOTING THAT IF THERE A CLINICAL CONCERN REGARDING A PONTINE INFARCT, BRAIN MRI MIGHT BE HELPFUL. PER NEUROLOGIC CARE TRENDS CHARTS, ON (B)(6) 2013, THE PATIENT WAS ORIENTED, OBEYED COMMANDS AND HAD SPEECH DIFFICULTY. THE NIH STROKE SCALE SCORE WAS NOT ASSESSED. ON (B)(6) 2013 AT 04:00, NO NEUROLOGICAL SYMPTOMS WERE NOTED WITH GLASGOW COMA SCORE OF 15; HOWEVER, ON THE SAME DATE AT 08:00, DISORIENTATION WAS NOTED ON THE CHART. ON (B)(6) 2013, ALTERED MEMORY/THINKING/SEIZURES WITH GLASGOW COMA SCORE OF 10 WAS NOTED. STARTING ON (B)(6) 2013 AT 20:00 AND (B)(6) 2013 AT 00:00, THE NEUROLOGIC CARE TRENDS CHART REPORTED ALTERED MEMORY/THINKING/SEIZURES, "CHANGES IN CONCENTRATION, DIFFICULTY SWALLOWING, WEAKNESS, LEFT SIDE WEAKNESS, RIGHT SIDE" [END OF RECORD]. THE PATIENT WAS AROUSABLE TO PAINFUL STIMULI, ORIENTATION WAS UNABLE TO BE ASSESSED, AND HE DID WITHDRAW TO THE PAIN. THE GLASGOW COMA SCORE WAS 6. THE NIH STROKE SCALE SCORE WAS NOT ASSESSED. THE SITE HAD REPORTED CEREBRAL HYPERPERFUSION SYNDROME ON (B)(6) 2013. COMPLAINT CONCLUSION UPDATED: PER THE SAPPHIRE STUDY ADJUDICATION COMMITTEE, A PATIENT EXPERIENCED CEREBRAL HYPERFUSION SYNDROME AND BRADYCARDIA DURING THE CAROTID INDEX PROCEDURE. THE PATIENT ALSO DEVELOPED APHASIA WITH PROGRESSIVELY INCREASING BLOOD PRESSURE ON THE SAME DAY OF THE INDEX PROCEDURE. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 80% STENOSIS TO THE LEFT OSTIUM INTERNAL CAROTID ARTERY. PRE-PROCEDURE NIH STROKE SCALE WAS 0, THE STROKE SCALE WAS 0 AND THE PATIENT WAS ASYMPTOMATIC. THE LESION WAS DESCRIBED AS 20MM IN LENGTH, CONCENTRIC, ARCH TYPE I AND MODERATELY TORTUOUS. THE LESION WAS ECCENTRIC AND THROMBUS WAS PRESENT WITHIN THE LESION AND ULCERATED. THE REFERENCE VESSEL WAS 8.0 IN DIAMETER. A 8MM ANGIOGUARD WAS DEPLOYED SUCCESSFULLY BEYOND THE TARGET LESION AND THE LESION WAS PRE-DILATED. A 9.0 X 40MM PRECISE PRO RX WAS IMPLANTED AT THE TARGET LESION. THE ANGIOGUARD WAS RETRIEVED AND DEBRIS WAS NOTED IN THE FILTER BASKET. IT IS UNKNOWN IF AIR BUBBLES WERE PRESENT. THERE WAS 30% RESIDUAL STENOSIS. ACCORDING TO CATHETERIZATION REPORT, THE PATIENT DEVELOPED TRANSIENT CONFUSION, WHICH RESOLVED AT THE END OF THE PROCEDURE. HE WAS ALERT, ORIENTED AND HAD NO NEUROLOGICAL DEFICITS. THE PROCEDURE WAS ALSO REMARKABLE FOR SINUS BRADYCARDIA IN HIGH 30S - LOW 40S, TREATED WITH ATROPINE WITH HEART RATE STAYING AT 60S. OPERATOR ALSO NOTED A DROP IN BLOOD PRESSURE FORM 220 MMHG SYSTOLIC TO ABOUT 140 MMHG AT THE END OF THE PROCEDURE. THE PATIENT WAS TRANSFERRED TO THE HOLDING AREA IN STABLE CONDITION. ON (B)(6) 2013 AT 21:30, THE PATIENT DEVELOPED APHASIA WITH PROGRESSIVELY INCREASING BLOOD PRESSURE. THIS WAS FOLLOWED BY GENERALIZED TONIC SEIZURE ACTIVITY. A STROKE ALERT WAS CALLED. THE PATIENT WAS TRANSFERRED TO ICU AND INTUBATED FOR AIRWAY PROTECTION. IV KEPPRA LOADING DOSE WAS GIVEN, AFTER WHICH NO OVERT SEIZURES WERE OBSERVED. PER NEUROLOGY CONSULTATION NOTE ON (B)(6) 2013, THE PATIENT HAD REMAINED VERY AGITATED AND APHASIC SINCE THIS EVENT, AND REQUIRED USE OF SEDATING AGENTS OVERNIGHT "TO MAINTAIN VENTILATORY STATUS." PER NEUROLOGICAL EXAM DESCRIPTION, THE PATIENT WAS UNRESPONSIVE AND SEDATED. CRANIAL NERVE EXAMINATION REVEALED THAT GAZE WAS AT MIDLINE, THE PUPILS WERE 2 MM IN SIZE AND REACTIVE. NEUROLOGY CONSULTATION IMPRESSION: REPERFUSION SYNDROME WITH DIFFERENTIAL DIAGNOSIS TO INCLUDE EMBOLIC EVENTS FROM THE CAROTID STENT AND ISCHEMIC STROKE. A HEAD CT SCAN ON (B)(6) 2013 REVEALED THE FOLLOWING, ACCORDING TO RADIOLOGY REPORT IMPRESSION: 1) NO ACUTE INTRACRANIAL HEMORRHAGE OR DEFINITE MASS EFFECT; 2) QUESTIONABLE SMALL HYPODENSITY IN THE ANTERIOR RIGHT PONS. BILATERAL CAROTID ULTRASOUND ON (B)(6) 2013 AT 04:15 REVEALED LEFT ICA STENT, MAXIMAL ICA VELOCITY 194 CM/SEC; ICA/CCA RATIO 2.3, AND A PATENT CCA. IMPRESSION: A 50-69% STENOSIS OF THE LEFT ICA. FOR THE RIGHT CAROTID ARTERY, THERE WAS A 50-69% STENOSIS IN THE RIGHT ICA AND A PATENT CCA. ANTEGRADE FLOW IN THE VERTEBRAL ARTERIES WAS NOTED. A FOLLOW-UP HEAD CT SCAN ON (B)(6) 2013 REPORTED NO SIGNIFICANT HEAD CT ABNORMALITY. PER NEUROLOGIC CARE TRENDS CHARTS, ON (B)(6) 2013, THE PATIENT WAS ORIENTED, OBEYED COMMANDS AND HAD SPEECH DIFFICULTY. THE NIH STROKE SCALE SCORE WAS NOT ASSESSED. ON (B)(6) 2013 DISORIENTATION WAS NOTED ON THE CHART. ON (B)(6) 2013, ALTERED MEMORY/THINKING/SEIZURES WITH GLASGOW COMA SCORE OF 10 WAS NOTED. STARTING ON (B)(6) 2013 AT 20:00 AND (B)(6) 2013 AT 00:00, THE NEUROLOGIC CARE TRENDS CHART REPORTED ALTERED MEMORY/THINKING/SEIZURES, "CHANGES IN CONCENTRATION, DIFFICULTY SWALLOWING, WEAKNESS, LEFT SIDE WEAKNESS,RIGHT SIDE. THE PATIENT WAS AROUSABLE TO PAINFUL STIMULI, ORIENTATION WAS UNABLE TO BE ASSESSED, AND HE DID WITHDRAW TO THE PAIN. THE GLASGOW COMA SCORE WAS 6. THE NIH STROKE SCALE SCORE WAS NOT ASSESSED. THE PATIENT¿S MEDICAL HISTORY INCLUDE HYPERLIPIDEMIA, ABNORMAL STRESS TEST, SMOKING, CORONARY ARTERY DISEASE AND HYPERTENSION (SYSTOLIC>140, OR DIASTOLIC>90, OR REQUIRING MEDICATION). HIGH RISK CRITERIA: ABNORMAL STRESS TEST. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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 15678349 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. 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. NEUROLOGICAL SYMPTOMS CAN OCCUR AS A RESULT OF DECREASED BLOOD SUPPLY TO THE BRAIN CAUSED BY THE HYPOTENSION/BRADYCARDIA. HYPOPERFUSION IS A WELL-KNOWN POTENTIAL ADVERSE EVENTS 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. VESSEL SPASM IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ANY INTERVENTIONAL PROCEDURE WHERE DEVICES ARE INTRODUCED INTO THE VASCULATURE AND IS LISTED IN THE IFU (INSTRUCTIONS FOR USE) AS SUCH. 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. ARTERIAL RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE. PROGRESSION OF ATHEROSCLEROTIC DISEASE IS KNOWN TO CAUSE INSTENT RESTENOSIS AND DOES NOT INDICATE A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS AND IT NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. THERE ARE PATIENT AND LESION CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. THERE IS NO EVIDENCE THAT MANUFACTURING ISSUES CONTRIBUTED TO THESE EVENTS. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT, VESSEL AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. THEREFORE, NO CORRECTION ACTION WILL BE TAKEN.
COMPLAINT CONCLUSION: AS REPORTED VIA THE (B)(6), A PATIENT EXPERIENCED CEREBRAL HYPERFUSION SYNDROME THE SAME DAY OF THE INDEX PROCEDURE. THEN TWELVE DAYS POST PROCEDURE THE PATIENT EXPIRED. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 80% STENOSIS TO THE LEFT OSTIUM INTERNAL CAROTID ARTERY. PRE-PROCEDURE NIH STROKE SCALE WAS 0, THE STROKE SCALE WAS 0 AND THE PATIENT WAS ASYMPTOMATIC. THE LESION WAS DESCRIBED AS 20MM IN LENGTH, CONCENTRIC, ARCH TYPE I AND MODERATELY TORTUOUS. THE LESION WAS ECCENTRIC AND THROMBUS WAS PRESENT WITHIN THE LESION AND ULCERATED. THE REFERENCE VESSEL WAS 8.0 IN DIAMETER. A 8MM ANGIOGUARD WAS DEPLOYED SUCCESSFULLY BEYOND THE TARGET LESION AND THE LESION WAS PRE-DILATED. A 9.0 X 40MM PRECISE PRO RX WAS IMPLANTED AT THE TARGET LESION. THE ANGIOGUARD WAS RETRIEVED AND DEBRIS WAS NOTED IN THE FILTER BASKET. IT IS UNKNOWN IF AIR BUBBLES WERE PRESENT. THERE WAS 30% RESIDUAL STENOSIS. THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITH NO NEUROLOGICAL DEFICITS. ON THE SAME DAY OF THE INDEX PROCEDURE, THE PATIENT EXPERIENCED SUDDEN BEHAVIORAL CHANGES AND APHASIA. THE SYMPTOMS WERE DIAGNOSED AS CEREBRAL HYPERFUSION SYNDROME. THE PATIENT FULLY RECOVERED WITH NO DEFICITS MORE THAN 24 HOURS LATER. THE POST NIH STROKE SCALE AND STROKE SCALE ARE UNKNOWN. THEN, TWELVE DAYS LATER THE PATIENT EXPIRED. THE CAUSE OF DEATH IS UNKNOWN. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT EXPIRED DUE TO COMPLICATIONS OF PNEUMONIA AND ACUTE RENAL FAILURE. THERE WERE NO AIR BUBBLES PRESENT DURING THE INDEX PROCEDURE. THE PATIENT WAS ANTICOAGULATED. THE SYMPTOMS BEGAN APPROXIMATELY 10 HOURS POST PROCEDURE. THE PATIENT¿S MEDICAL HISTORY INCLUDE HYPERLIPIDEMIA, ABNORMAL STRESS TEST, SMOKING, CORONARY ARTERY DISEASE AND HYPERTENSION (SYSTOLIC>140, OR DIASTOLIC>90, OR REQUIRING MEDICATION). HIGH RISK CRITERIA: ABNORMAL STRESS TEST. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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 15678349 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. HYPOPERFUSION IS A WELL-KNOWN POTENTIAL ADVERSE EVENTS 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. VESSEL SPASM IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ANY INTERVENTIONAL PROCEDURE WHERE DEVICES ARE INTRODUCED INTO THE VASCULATURE AND IS LISTED IN THE IFU (INSTRUCTIONS FOR USE) AS SUCH. 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 CORRECTION ACTION WILL BE TAKEN.
AS REPORTED VIA THE (B)(6) REGISTRY, A PATIENT EXPERIENCED CEREBRAL HYPERFUSION SYNDROME THE SAME DAY OF THE INDEX PROCEDURE. THEN TWELVE DAYS POST PROCEDURE THE PATIENT EXPIRED. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 80% STENOSIS TO THE LEFT OSTIUM INTERNAL CAROTID ARTERY. PRE-PROCEDURE NIH STROKE SCALE WAS 0, THE STROKE SCALE WAS 0 AND THE PATIENT WAS ASYMPTOMATIC. THE LESION WAS DESCRIBED AS 20MM IN LENGTH, CONCENTRIC, ARCH TYPE I AND MODERATELY TORTUOUS. THE LESION WAS ECCENTRIC AND THROMBUS WAS PRESENT WITHIN THE LESION AND ULCERATED. THE REFERENCE VESSEL WAS 8.0 IN DIAMETER. A 8MM ANGIOGUARD WAS DEPLOYED SUCCESSFULLY BEYOND THE TARGET LESION AND THE LESION WAS PRE-DILATED. A 9.0 X 40MM PRECISE PRO RX WAS IMPLANTED AT THE TARGET LESION. THE ANGIOGUARD WAS RETRIEVED AND DEBRIS WAS NOTED IN THE FILTER BASKET. IT IS UNKNOWN IF AIR BUBBLES WERE PRESENT. THERE WAS 30% RESIDUAL STENOSIS. THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITH NO NEUROLOGICAL DEFICITS. ON THE SAME DAY OF THE INDEX PROCEDURE, THE PATIENT EXPERIENCED SUDDEN BEHAVIORAL CHANGES AND APHASIA. THE SYMPTOMS WERE DIAGNOSED AS CEREBRAL HYPERFUSION SYNDROME. THE PATIENT FULLY RECOVERED WITH NO DEFICITS MORE THAN 24 HOURS LATER. THE POST NIH STROKE SCALE AND STROKE SCALE ARE UNKNOWN. THEN, TWELVE DAYS LATER THE PATIENT EXPIRED. THE CAUSE OF DEATH IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 173293 | PRECISE PRO RX CAROTID STENT SYSTEM | SELF EXPANDING STENTS (NIM) | NIM | CORDIS DE MEXICO | NA | 15678349 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Death |