PRECISE PRO RX CAROTID STENT SYSTEM

Report

Report Number: 9616099-2013-00114
Event Type: Injury
Date Received: March 1, 2013
Date of Event: December 4, 2012
Report Date: December 29, 2012
Manufacturer: CORDIS DE MEXICO
Product Code: NIM
PMA / PMN Number: P030047
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: WV, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

DURING THIS EPISODE, SHE ALSO HAD SOME TINGLING IN THE LEFT HAND; OTHER CONSULTATION NOTE REPORTED THAT "SHE DENIED ANY NUMBNESS OR TINGLING OF ANY OTHER EXTREMITIES." SHE WENT TO SLEEP AND THOUGHT IT WOULD BE BETTER IN THE MORNING, BUT SHE STILL HAD RESIDUAL DEFICITS IN THE MORNING. OTHER CONSULTATION REPORT NOTED THAT SHE FELT HER NORMAL SELF NEXT DAY MORNING. SHE WAS BROUGHT TO HER PRIMARY CARE PHYSICIAN, WHO SENT HER TO EMERGENCY ROOM. A BRAIN CT SCAN ON (B)(6) 2012 IN EMERGENCY ROOM SHOWED NO ACUTE FINDINGS AND NO CHANGE, COMPARED TO A STUDY ON (B)(6) 2012. ON (B)(6) 2012, THE NIH STROKE SCALE SCORE WAS 2 DUE TO PARTIAL GAZE PALSY ("PATIENT DOES NOT SEEM TO BE ABLE TO FOLLOW ALL THE WAY LATERALLY ON BOTH SIDES") AND PARTIAL HEMIANOPIA ("RIGHT UPPER PERIPHERAL SEEMS TO BE DECREASED"). THE NIH WORKSHEET REPORTED NO DYSARTHRIA, NO APHASIA AND NO MOTOR DEFICITS. NEUROLOGY IMPRESSION: POSSIBLE TIA VERSUS STROKE. FURTHER WORKUP WAS RECOMMENDED. DURING THIS ADMISSION, HER ECG INITIALLY SHOWED SINUS TACHYCARDIA WITH MULTIPLE PVCS, FURTHER ONE VENTRICULAR BIGEMINY ON MONITOR WAS NOTED, WHICH WARRANTED EP CONSULTATION AFTER DISCHARGE). A CTA OF THE NECK ON (B)(6) 2012 SHOWED WIDELY PATENT STUDY STENT IN THE RIGHT ICA AND A 60% STENOSIS IN THE PROXIMAL LEFT ICA. A CTA OF THE BRAIN ON (B)(6) 2012 WITHOUT CONTRAST SHOWED NO EVIDENCE OF INTRACRANIAL HEMORRHAGE OR ACUTE INFARCTION. CT PERFUSION ANGIOGRAPHY DEMONSTRATED QUESTIONABLE AREA OF INCREASED MEAN TRANSIT TIME IN THE LEFT MIDDLE CEREBRAL ARTERY TERRITORY. THIS REPRESENTS A SMALL COMPLETED INFARCT AS DEMONSTRATED IN CEREBRAL BLOOD VOLUMES. CT ANGIOGRAPHY OF THE BRAIN DEMONSTRATED THE VESSEL TO BE WIDELY PATENT. RADIOLOGY REPORT CONCLUSION: SMALL INFARCT IN THE LEFT MIDDLE CEREBRAL ARTERY TERRITORY PERIPHERALLY. ON (B)(6) 2012 THE NIH STROKE SCALE SCORE WAS 0. COMPLAINT CONCLUSION: THE (B)(4) STUDY ADJUDICATION COMMITTEE DETERMINED THAT THE PATIENT EXPERIENCED A CVA-MINOR, IPSILATERAL, ISCHEMIC/EMBOLIC SIX DAYS AFTER THE INDEX PROCEDURE. THE EVENT HAD BEEN PREVIOUSLY REPORTED AS A TIA BY THE SITE. PRE-PROCEDURE NIH STROKE SCALE WAS 0 AND THE PATIENT WAS ASYMPTOMATIC. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 90% STENOSIS TO THE RIGHT OSTIUM INTERNAL CAROTID ARTERY. THE LESION WAS DESCRIBED AS 20MM IN LENGTH, SEVERELY CALCIFIED, ARCH TYPE II AND ECCENTRIC. THE REFERENCE VESSEL WAS 6.0 IN DIAMETER. A 5MM ANGIOGUARD WAS DEPLOYED BEYOND THE TARGET LESION AND THE LESION WAS PRE-DILATED. A 8.0 X 40MM PRECISE PRO RX WAS IMPLANTED AT THE TARGET LESION. THE ANGIOGUARD WAS RETRIEVED AND DEBRIS WAS NOT NOTED IN THE FILTER BASKET. THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITH NO NEUROLOGICAL DEFICITS. THE POST NIH STROKE SCALE WAS 0 AND WAS DISCHARGED TWO DAYS LATER. CONCOMITANT MEDICATIONS INCLUDED CLOPIDOGREL AND ASPIRIN AT PRE AND POST PROCEDURE AND AT DISCHARGE. THEN, SIX DAYS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED SUDDEN DYSARTHRIA AND LEFT SIDE HEMIPARESIS. THE SYMPTOMS WERE DIAGNOSED AS A TIA. THE DURATION OF SYMPTOMS WAS LESS THAN 24 HOURS AND FULLY RESOLVED WITH NO DEFICITS. AT THE TIME OF THE EVENT, THE PATIENT WAS TAKING ASPIRIN AND PLAVIX. SHE ALSO WAS STARTED ON SIMVASTATIN TO LOWER LIPID LEVELS. THE CT SCAN INDICATED NO SIGNIFICANT FINDINGS. PER THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO THE INDEX PROCEDURE OR THE CORDIS PRODUCT. LATER THAT DAY, PER A CONSULTATION NOTE ((B)(6) 2012 AT APPROXIMATELY 21:00), SHE DEVELOPED SLURRED SPEECH. AT THAT TIME, IT WAS UNCLEAR WHETHER IT WAS APHASIA VERSUS DYSARTHRIA. SHE FELT THAT HER TONGUE WAS TOO BIG FOR HER MOUTH. SHE WAS DIZZY AND FELT "SWIMMY-HEADED" WITH SOME GENERALIZED WEAKNESS. DURING THIS EPISODE, SHE ALSO HAD SOME TINGLING IN THE LEFT HAND; OTHER CONSULTATION NOTE REPORTED THAT "SHE DENIED ANY NUMBNESS OR TINGLING OF ANY OTHER EXTREMITIES." SHE WENT TO SLEEP AND THOUGHT IT WOULD BE BETTER IN THE MORNING, BUT SHE STILL HAD RESIDUAL DEFICITS IN THE MORNING. OTHER CONSULTATION REPORT NOTED THAT SHE FELT HER NORMAL SELF NEXT DAY MORNING. SHE WAS BROUGHT TO HER PRIMARY CARE PHYSICIAN, WHO SENT HER TO EMERGENCY ROOM. A BRAIN CT SCAN ON (B)(6) 2012 IN EMERGENCY ROOM SHOWED NO ACUTE FINDINGS AND NO CHANGE, COMPARED TO A STUDY ON (B)(6) 2012. ON (B)(6) 2012, THE NIH STROKE SCALE SCORE WAS 2 DUE TO PARTIAL GAZE PALSY ("PATIENT DOES NOT SEEM TO BE ABLE TO FOLLOW ALL THE WAY LATERALLY ON BOTH SIDES") AND PARTIAL HEMIANOPIA ("RIGHT UPPER PERIPHERAL SEEMS TO BE DECREASED"). THE NIH WORKSHEET REPORTED NO DYSARTHRIA, NO APHASIA AND NO MOTOR DEFICITS. NEUROLOGY IMPRESSION: POSSIBLE TIA VERSUS STROKE. FURTHER WORKUP WAS RECOMMENDED. DURING THIS ADMISSION, HER ECG INITIALLY SHOWED SINUS TACHYCARDIA WITH MULTIPLE PVCS, FURTHER ONE VENTRICULAR BIGEMINY ON MONITOR WAS NOTED, WHICH WARRANTED EP CONSULTATION AFTER DISCHARGE). A CTA OF THE NECK ON (B)(6) 2012 SHOWED WIDELY PATENT STUDY STENT IN THE RIGHT ICA AND A 60% STENOSIS IN THE PROXIMAL LEFT ICA. A CTA OF THE BRAIN ON (B)(6) 2012 WITHOUT CONTRAST SHOWED NO EVIDENCE OF INTRACRANIAL HEMORRHAGE OR ACUTE INFARCTION. CT PERFUSION ANGIOGRAPHY DEMONSTRATED QUESTIONABLE AREA OF INCREASED MEAN TRANSIT TIME IN THE LEFT MIDDLE CEREBRAL ARTERY TERRITORY. THIS REPRESENTS A SMALL COMPLETED INFARCT AS DEMONSTRATED IN CEREBRAL BLOOD VOLUMES. CT ANGIOGRAPHY OF THE BRAIN DEMONSTRATED THE VESSEL TO BE WIDELY PATENT. RADIOLOGY REPORT CONCLUSION: SMALL INFARCT IN THE LEFT MIDDLE CEREBRAL ARTERY TERRITORY PERIPHERALLY. ON (B)(6) 2012 THE NIH STROKE SCALE SCORE WAS 0. THE HOSPITAL DISCHARGE DIAGNOSIS REPORTED TRANSIENT ISCHEMIC ATTACK; TRANSIENT ISCHEMIC ATTACK VERSUS INFARCT. THE PATIENT WAS DISCHARGED ON (B)(6) 2012. ON (B)(6) 2012 AT 30 DAY FOLLOW-UP, THE NIH STROKE SCALE SCORE WAS NOT EVALUATED AND THE RANKIN STROKE SCALE SCORE WAS 0. PATIENT'S MEDICAL HISTORY INCLUDE HYPERLIPIDEMIA, SMOKING, HYPERTENSION (SYSTOLIC>140, OR DIASTOLIC>90, OR REQUIRING MEDICATION). THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AS IT REMAINS IMPLANTED. 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. EMBOLIC STROKE IS A WELL DOCUMENTED POTENTIAL COMPLICATION OF CAROTID ARTERY INTERVENTIONS AND IS LISTED IN THE IFU AS SUCH. EMBOLIC STROKES ARE USUALLY CAUSED BY AN EMBOLUS (A BLOOD CLOT THAT FORMS ELSEWHERE IN THE BODY AND TRAVELS THROUGH THE BLOODSTREAM TO THE BRAIN) THAT TRAVELS FROM OTHER PARTS OF THE BODY TO THE NECK OR BRAIN AND BLOCKS A BLOOD VESSEL. EMBOLIC STROKES OFTEN RESULT FROM HEART DISEASE OR HEART SURGERY AND OCCUR RAPIDLY AND WITHOUT ANY WARNING SIGNS. ABOUT 15 PERCENT OF EMBOLIC STROKES OCCUR IN PEOPLE WITH ATRIAL FIBRILLATION. WHEN A CLOT FORMS IN A BLOOD VESSEL IN THE BRAIN OR NECK IT IS CALLED A THROMBOTIC STROKE. EMBOLIC AND THROMBOTIC STROKES ARE CATEGORIZED AS ISCHEMIC STROKE. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT, PHARMACEUTICAL, VESSEL AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED THE EVENT DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS.

Description of Event or Problem · 1

THE (B)(4) STUDY ADJUDICATION COMMITTEE HAS DETERMINED THAT THE PATIENT EXPERIENCED A CVA-MINOR, IPSILATERAL, ISCHEMIC/EMBOLIC SIX DAYS AFTER THE INDEX PROCEDURE. THE EVENT HAD BEEN PREVIOUSLY REPORTED AS A TIA BY THE SITE. PRE-PROCEDURE NIH STROKE SCALE WAS 0 AND THE PATIENT WAS ASYMPTOMATIC. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 90% STENOSIS TO THE RIGHT OSTIUM INTERNAL CAROTID ARTERY. THE LESION WAS DESCRIBED AS 20MM IN LENGTH, SEVERELY CALCIFIED, ARCH TYPE II AND ECCENTRIC. THE REFERENCE VESSEL WAS 6.0 IN DIAMETER. A 5MM ANGIOGUARD WAS DEPLOYED BEYOND THE TARGET LESION AND THE LESION WAS PRE-DILATED. A 8.0 X 40MM PRECISE PRO RX WAS IMPLANTED AT THE TARGET LESION. THE ANGIOGUARD WAS RETRIEVED AND DEBRIS WAS NOT NOTED IN THE FILTER BASKET. THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITH NO NEUROLOGICAL DEFICITS. THE POST NIH STROKE SCALE WAS 0 AND WAS DISCHARGED TWO DAYS LATER. CONCOMITANT MEDICATIONS INCLUDED CLOPIDOGREL AND ASPIRIN AT PRE AND POST PROCEDURE AND AT DISCHARGE. THEN, SIX DAYS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED SUDDEN DYSARTHRIA AND LEFT SIDE HEMIPARESIS. THE SYMPTOMS WERE DIAGNOSED AS A TIA. THE DURATION OF SYMPTOMS WAS LESS THAN 24 HOURS AND FULLY RESOLVED WITH NO DEFICITS. AT THE TIME OF THE EVENT, THE PATIENT WAS TAKING ASPIRIN AND PLAVIX. SHE ALSO WAS STARTED ON SIMVASTATIN TO LOWER LIPID LEVELS. THE CT SCAN INDICATED NO SIGNIFICANT FINDINGS. PER THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO THE INDEX PROCEDURE OR THE CORDIS PRODUCT. LATER THAT DAY, PER A CONSULTATION NOTE ((B)(6) 2012 AT APPROXIMATELY 21:00), SHE DEVELOPED SLURRED SPEECH. AT THAT TIME, IT WAS UNCLEAR WHETHER IT WAS APHASIA VERSUS DYSARTHRIA. SHE FELT THAT HER TONGUE WAS TOO BIG FOR HER MOUTH. SHE WAS DIZZY AND FELT "SWIMMY-HEADED" WITH SOME GENERALIZED WEAKNESS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
88881	PRECISE PRO RX CAROTID STENT SYSTEM	SELF EXPANDING STENTS (NIM)	NIM	CORDIS DE MEXICO	NA	15686262

Patients

Seq	Age	Sex	Outcome	Treatment
1	77 YR		Hospitalization\| L\| S