PRECISE PRO RX CAROTID STENT SYSTEM
Report
- Report Number
- 9616099-2013-00238
- Event Type
- Injury
- Date Received
- April 22, 2013
- Date of Event
- December 20, 2012
- Report Date
- January 4, 2013
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIM
- PMA / PMN Number
- P030047
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
ADDENDUM: THE (B)(4) STUDY FILE WAS ADJUDICATED ON (B)(4) 2013. THE ADJUDICATION COMMITTEE DETERMINED THAT THE PATIENT HAD A MINOR CVA, IPSILATERAL ISCHEMIC/EMBOLIC WITH AN EVENT DATE OF (B)(6) 2013. THE PATIENT WAS ADMITTED ON (B)(6) 2013 FOR FALLING AND SLURRED SPEECH. THE NEUROLOGY CONSULTATION NOTE ON (B)(6) 2013 INDICATED THAT THE PATIENT DID WELL AT HOME FOR A FEW DAYS POST-PROCEDURE, BUT THEN SHE EMERGED THE PATTERN WHERE, WHEN SHE WAS UP, SHE WOULD BE BLANK, TALKING OUT OF HER HEAD, OR FALLING RIGHT AND SLURRING HER SPEECH. AS SHE WOULD THEN LIE DOWN, SHE WOULD BE PERFECTLY FINE AGAIN, BUT THE GENERAL SENSE WAS THAT IT WAS GETTING STEADILY WORSE. THE PATIENT'S OPINION WAS THAT SHE WAS LIGHTHEADED AND COULD NOT MAINTAIN HER BALANCE, BUT HER FAMILY FELT IT WOULD BE BEST TO HAVE HER HOSPITALIZED FOR FURTHER EVALUATION. HER BLOOD PRESSURE ON ADMISSION WAS ELEVATED AT 182/98. ON PHYSICAL EXAMINATION, HER LANGUAGE WAS FULLY INTACT. THE NEUROLOGIST NOTED THAT ON RARE OCCASION, SLURRING OF SPEECH COULD BE DISCERNED, BUT THE PATIENT WAS LOGICAL AND APPROPRIATE. ON MOTOR TESTING, AT THAT TIME THERE WAS NO FOCAL DEFICITS, EXCEPT FOR SOME DROOPINESS OF HER LEFT EYE LID. THE NIH STROKE SCALE SCORE ON ADMISSION WAS NOT EVALUATED. A NEUROLOGY FOLLOW-UP NOTE ON (B)(6) 2013 REPORTED THAT THE PATIENT WAS ADMITTED WITH INTERMITTENT SYMPTOMS OF FEELING LIKE FALLING TO RIGHT. ON EXAM AT THAT TIME, SHE WAS ALERT AND ORIENTED, BUT WITH MILD DRIFT ON RIGHT. ASSESSMENT: QUESTION OF NEW LEFT HEMISPHERIC STROKE WITH A PLAN TO OBTAIN MRI. A BRAIN MRI ON (B)(6) 2013, COMPARED TO AN MRI ON (B)(6) 2012 REVEALED THE FOLLOWING, ACCORDING TO THE RADIOLOGY REPORT IMPRESSION: MULTIPLE SMALL FOCI OF SUBACUTE INFARCT, INVOLVING THE RIGHT MCA TERRITORY, MILD DIFFUSE PARENCHYMAL VOLUME LOSS AND SMALL VESSEL ISCHEMIC CHANGES, AND SMALL FOCI OF ENCEPHALOMALACIA INVOLVING THE LEFT MCA, CONSISTENT WITH PRIOR SMALL INFARCTS. ON (B)(6) 2013 THE NIH STROKE SCALE SCORE WAS 3 DUE TO FACIAL PALSY (1), LEFT ARM MOTOR IMPAIRMENT (1) AND MILD DYSARTHRIA. THE SITE REPORTED AN EVENT OF ISCHEMIC STROKE ON (B)(6) 2013. COMPLAINT CONCLUSION: AS REPORTED VIA THE (B)(4) REGISTRY, THIS IS (B)(6) FEMALE WITH A MEDICAL HISTORY OF CARDIAC ARRHYTHMIA, CORONARY ARTERY DISEASE, MYOCARDIAL INFARCTION AND CORONARY PERCUTANEOUS REVASCULARIZATION. THE STUDY ADJUDICATION COMMITTEE DETERMINED THAT THE PATIENT HAD A MINOR CVA, IPSILATERAL ISCHEMIC/EMBOLIC WITH AN EVENT THREE DAY POST INDEX PROCEDURE. PRE-PROCEDURE NIH STROKE SCALE WAS 0 AND THE PATIENT WAS SYMPTOMATIC. AT THE TIME OF THE INDEX PROCEDURE, THE RIGHT OSTIUM INTERNAL CAROTID ARTERY WAS TREATED. THE LESION WAS DESCRIBED HAVING 95% STENOSIS, 5MM IN LENGTH, CIRCUMFERENTIAL, MODERATELY CALCIFIED, ARCH TYPE I, MILDLY CALCIFIED, ECCENTRIC AND THROMBUS PRESENT WITHIN LESION. THE REFERENCE VESSEL WAS 6.0 IN DIAMETER. A 6MM ANGIOGUARD WAS DEPLOYED BEYOND THE TARGET LESION AND THE LESION WAS PRE-DILATED. A 9.0 X 30MM PRECISE PRO RX WAS IMPLANTED AT THE TARGET LESION. THE ANGIOGUARD WAS RETRIEVED AND DEBRIS WAS NOTED IN THE FILTER BASKET. NO AIR BUBBLES WERE NOTED. THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITH NO NEUROLOGICAL DEFICITS. THE POST RESIDUAL STENOSIS WAS 0% AND THE PATIENT WAS DISCHARGED TWO DAYS LATER. CONCOMITANT MEDICATIONS INCLUDED CLOPIDOGREL AND ASPIRIN AT PRE AND POST PROCEDURE AND AT DISCHARGE. THEN, THIRTY-TWO DAYS AFTER THE INDEX PROCEDURE, THE SITE REPORTED THAT THE PATIENT EXPERIENCED A TIA. THE EVENT WAS SUDDEN, WITH A FULL RECOVERY AND NO DEFICIT. THE SYMPTOMS LASTED LESS THAN 24 HOURS. PER THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO THE INDEX PROCEDURE OR THE STUDY DEVICE. THE (B)(4) STUDY FILE WAS ADJUDICATED ON (B)(6) 2013. THE ADJUDICATION COMMITTEE DETERMINED THAT THE PATIENT HAD A MINOR CVA, IPSILATERAL ISCHEMIC/EMBOLIC WITH AN EVENT DATE OF (B)(6) 2013. THE PATIENT WAS ADMITTED ON (B)(6) 2013 FOR FALLING AND SLURRED SPEECH. THE NEUROLOGY CONSULTATION NOTE ON (B)(6) 2013 INDICATED THAT THE PATIENT DID WELL AT HOME FOR A FEW DAYS POST-PROCEDURE, BUT THEN SHE EMERGED THE PATTERN WHERE, WHEN SHE WAS UP, SHE WOULD BE BLANK, TALKING OUT OF HER HEAD, OR FALLING RIGHT AND SLURRING HER SPEECH. AS SHE WOULD THEN LIE DOWN, SHE WOULD BE PERFECTLY FINE AGAIN, BUT THE GENERAL SENSE WAS THAT IT WAS GETTING STEADILY WORSE. THE PATIENT'S OPINION WAS THAT SHE WAS LIGHTHEADED AND COULD NOT MAINTAIN HER BALANCE, BUT HER FAMILY FELT IT WOULD BE BEST TO HAVE HER HOSPITALIZED FOR FURTHER EVALUATION. HER BLOOD PRESSURE ON ADMISSION WAS ELEVATED AT 182/98. ON PHYSICAL EXAMINATION, HER LANGUAGE WAS FULLY INTACT. THE NEUROLOGIST NOTED THAT ON RARE OCCASION, SLURRING OF SPEECH COULD BE DISCERNED, BUT THE PATIENT WAS LOGICAL AND APPROPRIATE. ON MOTOR TESTING, AT THAT TIME THERE WAS NO FOCAL DEFICITS, EXCEPT FOR SOME DROOPINESS OF HER LEFT EYE LID. THE NIH STROKE SCALE SCORE ON ADMISSION WAS NOT EVALUATED. A NEUROLOGY FOLLOW-UP NOTE ON (B)(6) 2013 REPORTED THAT THE PATIENT WAS ADMITTED WITH INTERMITTENT SYMPTOMS OF FEELING LIKE FALLING TO RIGHT. ON EXAM AT THAT TIME, SHE WAS ALERT AND ORIENTED, BUT WITH MILD DRIFT ON RIGHT. ASSESSMENT: QUESTION OF NEW LEFT HEMISPHERIC STROKE WITH A PLAN TO OBTAIN MRI. A BRAIN MRI ON (B)(6) 2013, COMPARED TO AN MRI ON (B)(6) 2012 REVEALED THE FOLLOWING, ACCORDING TO THE RADIOLOGY REPORT IMPRESSION: MULTIPLE SMALL FOCI OF SUBACUTE INFARCT, INVOLVING THE RIGHT MCA TERRITORY, MILD DIFFUSE PARENCHYMAL VOLUME LOSS AND SMALL VESSEL ISCHEMIC CHANGES, AND SMALL FOCI OF ENCEPHALOMALACIA INVOLVING THE LEFT MCA, CONSISTENT WITH PRIOR SMALL INFARCTS. ON (B)(6) 2013 THE NIH STROKE SCALE SCORE WAS 3 DUE TO FACIAL PALSY (1), LEFT ARM MOTOR IMPAIRMENT (1) AND MILD DYSARTHRIA. THE SITE REPORTED AN EVENT OF ISCHEMIC STROKE ON (B)(6) 2013. THE DEVICE WAS NOT RETURNED FOR ANALYSIS AS IT REMAINS IMPLANTED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH PRECISE LOT NUMBER PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. 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. 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.
AS REPORTED VIA THE (B)(4) REGISTRY, A PATIENT EXPERIENCED A TIA THIRTY-TWO DAYS AFTER THE INDEX PROCEDURE. AT THE TIME OF THE INDEX PROCEDURE, THE RIGHT OSTIUM INTERNAL CAROTID ARTERY WAS TREATED. PRE-PROCEDURE NIH STROKE SCALE WAS 0 AND THE PATIENT WAS SYMPTOMATIC. THE LESION WAS DESCRIBED HAVING 95% STENOSIS, 5MM IN LENGTH, CIRCUMFERENTIAL, MODERATELY CALCIFIED, ARCH TYPE I, MILDLY CALCIFIED, ECCENTRIC AND THROMBUS PRESENT WITHIN LESION. THE REFERENCE VESSEL WAS 6.0 IN DIAMETER. A 6MM ANGIOGUARD WAS DEPLOYED BEYOND THE TARGET LESION AND THE LESION WAS PRE-DILATED. A 9.0 X 30MM PRECISE PRO RX WAS IMPLANTED AT THE TARGET LESION. THE ANGIOGUARD WAS RETRIEVED AND DEBRIS WAS NOTED IN THE FILTER BASKET. NO AIR BUBBLES WERE NOTED. THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITH NO NEUROLOGICAL DEFICITS. THE POST RESIDUAL STENOSIS WAS 0% AND THE PATIENT WAS DISCHARGED TWO DAYS LATER. CONCOMITANT MEDICATIONS INCLUDED CLOPIDOGREL AND ASPIRIN AT PRE AND POST PROCEDURE AND AT DISCHARGE. THEN, THIRTY-TWO DAYS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED A TIA. THE EVENT WAS SUDDEN, WITH A FULL RECOVERY AND NO DEFICIT. THE SYMPTOMS LASTED LESS THAN 24 HOURS. THE PATIENT WAS TREATED WITH ASPIRIN, STATINS AND SPEECH THERAPY. PER THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO THE INDEX PROCEDURE OR THE STUDY DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 171201 | PRECISE PRO RX CAROTID STENT SYSTEM | SELF EXPANDING STENTS (NIM) | NIM | CORDIS DE MEXICO | NA | 15614671 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Hospitalization| L |