ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM
Report
- Report Number
- 1016427-2013-00054
- Event Type
- Injury
- Date Received
- May 3, 2013
- Date of Event
- April 9, 2013
- Report Date
- April 10, 2013
- Manufacturer
- CORDIS CORPORATION
- Product Code
- NTE
- PMA / PMN Number
- K062531
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH
- Reporter Occupation
- OTHER
Narratives
ADJUDICATION MINUTES WERE RECEIVED AND AGREED WITH THE PREVIOUS DETERMINATION THAT THE PATIENT SUFFERED A CVA/ISCHEMIC STROKE. THE ADJUDICATION MINUTES ALSO STATE THAT THE DEATH WAS NEUROLOGICALLY RELATED ALTHOUGH THE SITE STATES THE CAUSE OF DEATH AS CARDIOGENIC SHOCK. THE ADVERSE EVENT CODE OF TIA WILL BE UPDATED TO CVA. ADDITIONAL INFORMATION WAS ALSO RECEIVED AND NOTED THE FOLLOWING. THE PATIENT WAS A (B)(6) MAN WITH A HISTORY OF CHF III/IV CLASS, ICD IN SITU, HYPERTENSION, DYSLIPIDEMIA, CAD, CABG SURGERY, SMOKING, MI, PERCUTANEOUS CORONARY REVASCULARIZATION, AND BILATERAL CEA. PRE-PROCEDURE ON (B)(6) 2013, THE NIH STROKE SCALE SCORE WAS 0 AND THE RANKIN STROKE SCALE SCORE WAS 0. ON (B)(6) 2013 HE UNDERWENT THE INDEX PROCEDURE WITH DELIVERY OF THE ANGIOGUARD DEVICE, PRE-STENT BALLOON ANGIOPLASTY AND PLACEMENT OF TWO PRECISE PRO RX STENTS IN THE LEFT PROXIMAL INTERNAL CAROTID ARTERY (ICA). AFTER PLACEMENT OF STENTS, THE PATIENT DEVELOPED A MIDDLE CEREBRAL ARTERY (MCA) DISTRIBUTION SYMPTOMOLOGY, AND WAS "COMPLETELY FLACCID AND APHASIC." THE NEUROLOGICAL EVENT FORM REPORTED NEUROLOGICAL DEFICITS OF APHASIA, RIGHT VISUAL FIELD LOSS, RIGHT HEMINEGLECT AND RIGHT HEMIPARESIS OR HEMIPLEGIA. THE CEREBRAL ANGIOGRAM SHOWED NO OBVIOUS FILLING DEFECT IN THE ACA OR MCA DISTRIBUTION; DESPITE THIS, IA TPA WAS ADMINISTERED TWICE, AND FOLLOWING THIS, THERE WAS IMPROVEMENT IN FLOW IN THE M1 AND M2. AT THIS POINT, THE PATIENT'S CONDITION WAS IMPROVING: HE WENT FROM APHASIA TO SAYING HIS NAME, DATE OF BIRTH, AND HIS WIFE'S NAME; FROM BEING FLACCID ON HIS RIGHT ARM AND LEG TO THE POINT WHEN HE HAD 5/5 STRENGTH IN HIS RIGHT LEG AND 3/5 STRENGTH IN HIS HAND. AT THIS POINT, HIS BLOOD PRESSURE DIPPED TO 90S, AND HE WAS PLACED ON DOPAMINE. HE BECAME TACHYCARDIC. HIS BLOOD PRESSURE WAS STILL IN 90S, AND HE WAS PLACED ON IV FLUIDS. POST-STENT BALLOON ANGIOPLASTY WAS PERFORMED; THE ANGIOGUARD RX ECGW WAS RETRIEVED WITH DEBRIS FOUND IN THE FILTER. THE SITE REPORTED A 10% FINAL RESIDUAL IN-LESION STENOSIS. NEOSYNEPHRINE WAS ADMINISTERED. FOLLOWING THIS, HIS HEART RATE WAS NOTED TO BE FROM 1-TEENS TO 130S. AT THIS POINT, HE DEVELOPED UNRESPONSIVE HYPOTENSION, DESPITE ADMINISTRATION OF DOPAMINE, NEOSYNEPHRINE AND IV FLUIDS. THE PATIENT WAS INTUBATED, BUT HIS HYPOTENSION WAS STILL UNRESPONSIVE. PER PULMONARY CONSULTATION DURING THE PROCEDURE THE PATIENT APPEARED TO HAVE A STROKE, WAS GIVEN TPA, BUT SUBSEQUENTLY BECAME HYPOTENSIVE AND TACHYCARDIC WITH RAPID SHALLOW BREATHING. HE HAD CHEYNE-STOKES RESPIRATIONS AND WAS INTUBATED. PER CATHETERIZATION REPORT, IT WAS FELT THAT IT WAS A CARDIOGENIC SHOCK. IT WAS UNRESPONSIVE TO IABP OR OTHER INTERVENTIONS. THE CATHETERIZATION REPORT WAS CONCLUDED WITH IMPRESSION OF INTRA-OPERATIVE LEFT MCA DISTRIBUTION STROKE AND INTRA-OPERATIVE MI WITH DEVELOPMENT OF CARDIOGENIC SHOCK. ON THE NEUROLOGICAL EVENT FORM THE SITE REPORTED TIA WITH RESIDUAL DEFICITS. THE PATIENT WAS TAKEN TO THE ICU FOLLOWING THE PROCEDURE AND WAS CONTINUED RECEIVING VASOPRESSORS. FURTHER HE BECAME MORE OBTUNDED AND NOT RESPONSIVE. A BRAIN CT SCAN ON (B)(6) 2013 WITHOUT CONTRAST (NO STUDY FOR COMPARISON) REPORTED FINDINGS CONSISTENT WITH EVOLVING LARGE INFARCT IN THE LEFT MIDDLE CEREBRAL TERRITORY NOTING POOR GRAY-WHITE MATTER DIFFERENTIATION THROUGHOUT THE LEFT MIDDLE CEREBRAL TERRITORY IN ADDITION TO A MILD MASS EFFECT IN THE LEFT HEMISPHERE; THE SULCI WERE PARTIALLY EFFACED. THERE WAS NO EVIDENCE OF ACUTE HEMORRHAGE. FOLLOWING CT SCAN PROCEDURE, HE PATIENT WAS FOUND TO BE PULSELESS AND WAS CODED FOR 10 MINUTES. PULSE WAS REGAINED AND THE PATIENT WAS TRANSFERRED BACK TO THE FLOOR. HE EXPIRED ON THE SAME DATE. PER DISCHARGE SUMMARY, PATIENT LIKELY HAD A LARGE MI, THOUGH THIS WAS NOT CONFIRMED. THE SITE REPORTED CARDIAC CAUSE OF DEATH DUE TO CARDIOGENIC SHOCK. THIS MEDWATCH REPORT REPRESENTS ONE OF THREE PRODUCTS INVOLVED WITH THE REPORTED ADVERSE EVENTS AND ARE ASSOCIATED MANUFACTURER REPORT NUMBERS 9616099-2013-00270, 9616099-2013-00271 & 1016427-2013-00054.
PRECISE PRO RX: LOT NUMBER 15516206, CATALOG NUMBER PC0740RXC; PRECISE PRO RX: LOT NUMBER 15417126, CATALOG NUMBER PC0630RXC. THIS DEVICE IS NOT AVAILABLE FOR TESTING OR EVALUATION. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THE REPORTED ADVERSE EVENTS AND ARE ASSOCIATED MANUFACTURER REPORT NUMBERS 9616099-2013-00270 AND 9616099-2013-00271
AS REPORTED BY THE (B)(6) STUDY, A (B)(6) MALE, WITH A HISTORY OF FIRST-DEGREE RELATIVE WITH PREMATURE CAD, HYPERLIPIDEMIA, CONGESTIVE HEART FAILURE, CABG, HISTORY OF SMOKING, CORONARY ARTERY DISEASE, MYOCARDIAL INFARCTION, CORONARY PERCUTANEOUS REVASCULARIZATION AND HYPERTENSION, EXPERIENCED AN EMBOLIC STROKE AND EXPIRED. BASELINE NIH STROKE SCALE SCORE WAS 0. THE PATIENT WAS ASYMPTOMATIC AT THE TIME OF INTERVENTION. THE TARGET LESION IN THE LEFT PROXIMAL INTERNAL CAROTID ARTERY WAS 95% STENOSED AND 10 MM IN LENGTH. THE ARCH II LESION WAS CONCENTRIC, WITH MODERATE CALCIFICATION AND MILDLY TORTUOUS. A 5MM MEDIUM SUPPORT ANGIOGUARD DEVICE WAS DEPLOYED AND A 6X30MM PRECISE PRO RX STENT WAS SUCCESSFULLY DEPLOYED AT THE TARGET SITE AND A 7X40 MM PRECISE PRO STENT WAS ALSO DEPLOYED AT THE TARGET LESION. THE RESIDUAL DIAMETER STENOSIS MEASURED 10%. THE ANGIOGUARD WAS SUCCESSFULLY REMOVED AND DEBRIS WAS FOUND IN THE BASKET. THERE WAS NO DOCUMENTED DISSECTION OR PRESENCE OF AIR BUBBLES DURING THE PROCEDURE. AT THIS TIME THE SITE INDICATED THAT THE PATIENT HAD A SUDDEN ONSET OF VISUAL FIELD LOSS ON THE RIGHT SIDE AND APHASIA RESULTING IN A DIAGNOSIS OF EMBOLIC STROKE. IT IS UNKNOWN WHETHER THE PATIENT HAD RESIDUALS; HOWEVER, THE PATIENT LATER EXPIRED DUE TO CARDIOGENIC SHOCK. THE PHYSICIAN INDICATED THAT THE EVENT WAS RELATED TO THE PROCEDURE. THE PHYSICIAN INDICATED THAT THE EVENT WAS NOT RELATED TO THE DEVICE. 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. TIA IS A WELL-KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE AND IS LISTED IN THE IFU AS SUCH. 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 COLLECT IN THE EMBOLIC PROTECTION DEVICE OR FLOW DOWNSTREAM POTENTIALLY DISRUPTING PERFUSION BOTH DURING AND AFTER CAROTID STENT IMPLANTATION. BY DEFINITION (MAYOCLINIC.ORG), THE SYMPTOMS OF A TIA MAY LAST UP TO 24 HOURS, BUT THEY OFTEN LAST ONLY A FEW MINUTES. TIA OCCURS WHEN THE BLOOD SUPPLY TO PART OF THE BRAIN IS BRIEFLY INTERRUPTED. TIA SYMPTOMS ARE SIMILAR TO THOSE OF STROKE BUT DO NOT LAST AS LONG. MOST SYMPTOMS OF A TIA DISAPPEAR WITHIN AN HOUR. 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. TIA 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. 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. (B)(4). THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THE REPORTED ADVERSE EVENTS AND ARE ASSOCIATED MANUFACTURER REPORT NUMBERS 9616099-2013-00270 AND 9616099-2013-00271
AS REPORTED BY THE (B)(6) STUDY, THE SITE INDICATED THAT DURING INDEX PROCEDURE THE PATIENT EXPERIENCED THE EVENT OF AN EMBOLIC STROKE AND EXPIRED. BASELINE NIH STROKE SCALE SCORE WAS 0. THE PATIENT WAS ASYMPTOMATIC AT THE TIME OF INTERVENTION. THE TARGET LESION IN THE LEFT PROXIMAL INTERNAL CAROTID ARTERY WAS 95% STENOSED AND 10 MM IN LENGTH. THE ARCH II LESION WAS CONCENTRIC, WITH MODERATE CALCIFICATION AND MILDLY TORTUOUS. A 5MM MEDIUM SUPPORT ANGIOGUARD DEVICE WAS DEPLOYED AND A 6X30MM PRECISE PRO RX STENT WAS SUCCESSFULLY DEPLOYED AT THE TARGET SITE AND A 7X40 MM PRECISE PRO STENT WAS ALSO DEPLOYED AT THE TARGET LESION. THE RESIDUAL DIAMETER STENOSIS MEASURED 10%. THE ANGIOGUARD WAS SUCCESSFULLY REMOVED AND DEBRIS WAS FOUND IN THE BASKET. THERE WAS NO DOCUMENTED DISSECTION OR PRESENCE OF AIR BUBBLES DURING THE PROCEDURE. AT THIS TIME THE SITE INDICATED THAT THE PATIENT HAD A SUDDEN ONSET OF VISUAL FIELD LOSS ON THE RIGHT SIDE AND APHASIA RESULTING IN A DIAGNOSIS OF EMBOLIC STROKE. IT IS UNKNOWN WHETHER THE PATIENT HAD RESIDUALS; HOWEVER, THE PATIENT LATER EXPIRED DUE TO CARDIOGENIC SHOCK. THE PHYSICIAN INDICATED THAT THE EVENT WAS RELATED TO THE PROCEDURE. THE PHYSICIAN INDICATED THAT THE EVENT WAS NOT RELATED TO THE DEVICE OR THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 194360 | ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM | EMBOLIC PROTECTION DEVICE (NTE) | NTE | CORDIS CORPORATION | NA | 70113439 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Death |