BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 3222608 · Received July 12, 2013

    Report

    Report Number
    9616099-2013-00440
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 21, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. 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 15720925 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FOR THIS STUDY PATIENT. THE ADJUDICATION MINUTES WERE REVIEWED AND THE COMMITTEE NOTED: CVA - MAJOR IPSILATERAL ISCHEMIC/EMBOLIC WITH HEMORRHAGIC TRANSFORMATION ON THE DAY OF THE INDEX PROCEDURE AS PROCEDURE RELATED/DEVICE-RELATED ¿ AGREE. THE EVENT CAPTURED IN THE FILE WAS SUBARACHNOID HEMORRHAGE THREE DAYS AFTER THE INDEX PROCEDURE. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THERE IS NO CHANGE TO THE ADVERSE EVENT AS CAPTURED AND REPORTED. THERE IS NO CHANGE TO THE REPORTABILITY OF THE FILE OR THE COMPLAINT CONCLUSION. ADDITIONAL INFORMATION RECEIVED IN THE ADJUDICATION MINUTES: THE PATIENT UNDERWENT THE INDEX PROCEDURE WITH DELIVERY OF THE ANGIOGUARD¿ RX ECGW AND PLACEMENT OF ONE PRECISE® PRO RX STENT IN THE LEFT OSTIAL ICA. THE SITE REPORTED A 0% FINAL RESIDUAL STENOSIS. POST-PROCEDURE, THE PATIENT UNDERWENT A CT OF THE HEAD WITHOUT CONTRAST DUE TO A COMPLAINT OF LEFT CHEEK NUMBNESS AFTER THE INDEX PROCEDURE. THE IMPRESSION WAS: NO ACUTE HEMORRHAGE. NO ACUTE INFARCT. CONSULT WAS MADE TO NEUROLOGY FOR FURTHER EVALUATION OF POTENTIAL INFARCT AFTER LEFT CAROTID STENT. PRE-PROCEDURE THE NIH STROKE SCALE SCORE WAS 0 AND THE RANKIN SCORE WAS 0. POST-PROCEDURE THE STROKE SCALE SCORE WAS EVALUATED BY A DIFFERENT EXAMINER. THE NIH STROKE SCALE SCORE WAS NOT EVALUATED AND THE RANKIN SCORE WAS 0. THE PATIENT WAS DISCHARGED ON THE DAY AFTER THE PROCEDURE ON ASA AND CLOPIDOGREL. THE SITE REPORTED THAT THE PATIENT EXPERIENCED A STROKE (INTRACEREBRAL/SUBARACHNOID HEMORRHAGE) ON THREE DAYS POST-PROCEDURE. ON THE EVENING THE DAY AFTER THE PROCEDURE, THE PATIENT BEGAN HAVING A HEADACHE. THE PATIENT'S HUSBAND TRIED TO GET THE PATIENT TO RETURN TO THE HOSPITAL, BUT SHE REFUSED. SHE WAS TAKING ALL OF HER BLOOD PRESSURE MEDICATIONS, BUT THE HEADACHE CONTINUED TO WORSEN. THE PATIENT PRESENTED TO THE EMERGENCY ROOM ON THREE DAYS AFTER THE PROCEDURE WITH A SEVERE HOLOCEPHALIC HEADACHE AND SIGNIFICANT HYPERTENSION WITH HER SYSTOLIC BLOOD PRESSURE IN THE 200S MMHG. THE HEADACHE WAS LESSENED WITH THE ADMINISTRATION OF A NARCOTIC. ACCORDING TO THE NEUROLOGY CONSULT NOTE THE PATIENT HAD BEEN EVALUATED DURING THE INDEX HOSPITALIZATION FOR SOME SENSORY CHANGES IN HER LEFT HAND WITHOUT OTHER FOCAL FEATURES. SHE DENIED FOCAL DEFICITS ASIDE FROM PARASTHESIA IN THE LEFT FACE AND DIFFICULTY READING. THE PATIENT HAD BEEN EXPERIENCING A HEADACHE FOR 2 DAYS. THE NEUROLOGICAL EXAMINATION REVEALED THE FOLLOWING ABNORMALITIES: LANGUAGE WAS MILDLY ABNORMAL WITH IMPAIRED READING AND NAMING. SHE HAD SOME ELEMENTS OF PERSEVERATION. ALTHOUGH MUSCLE STRENGTH WAS 5/5 AND SYMMETRIC IN THE UPPER AND LOWER EXTREMITIES, THERE WAS SUBTLE RIGHT PRONATION AND DRIFT. A CT OF THE HEAD WITHOUT CONTRAST WAS PERFORMED. THE IMPRESSION WAS: SMALL (2.5 CM) PERIPHERAL AREA OF HEMORRHAGE IN THE POSTERIOR LEFT PARIETAL LOBE. THIS COULD BE RELATED TO A HEMORRHAGIC LOCALIZED ARTERIAL INFARCT. GIVEN THE PERIPHERAL LOCATION, HEMORRHAGIC INFARCT RELATED TO OVERLYING VENOUS SINUS THROMBOSIS WOULD BE ANOTHER CONSIDERATION ALTHOUGH THERE IS NO GROSS EVIDENCE OF DURAL SINUS THROMBOSIS OTHERWISE. THE NEUROLOGY CONSULT NOTE NOTED THAT THE PATIENT PRESENTED WITH THE WORST HEADACHE OF HER LIFE AND THERE WAS EVIDENCE OF CORTICAL LEFT PARIETAL BLEED WHICH WAS HIGHLY LIKELY TO BE A REPERFUSION INJURY. A PHYSICIAN'S ADDENDUM TO THE HISTORY AND PHYSICAL NOTED THAT THE "CT SCAN SHOWS HEMORRHAGE THAT IS MOSTLY RA CONVERSION OF AN EMBOLIC STROKE THAT DEVELOPED AT/POST STENT PLACEMENT.¿ FIVE DAYS POST-PROCEDURE THE NIH STROKE SCALE SCORE WAS EVALUATED BY A DIFFERENT EXAMINER. THE SCORE WAS 9 DUE TO ANSWERING BOTH QUESTIONS INCORRECTLY, LEFT LEG FALLING BEFORE 5 SECONDS, RIGHT LEG DRIFT DOWN BEFORE 5 SECONDS (BUT DOES NOT HIT BED), SEVERE APHASIA, ATAXIA IN 1 LIMB AND MILD TO MODERATE SLURRING OF WORDS. A HEAD CT WITHOUT CONTRAST WAS PERFORMED ON FOR A SEVERE HEADACHE. IT REVEALED A LEFT PARIETAL HEMATOMA APPEARING SLIGHTLY LARGER THAN PREVIOUS STUDY, MEASURING APPROXIMATELY 3 CM WITH MORE SURROUNDING EDEMA-MOST LIKELY A LOCALIZED HEMORRHAGIC INFARCT. A HEAD CT WITHOUT CONTRAST SHOWED A PARENCHYMAL HEMORRHAGE WITHIN THE LEFT PARIETOTEMPORAL REGION WHICH WAS STABLE IN APPEARANCE FROM PRIOR STUDY. NO NEW HEMORRHAGE WAS IDENTIFIED. THERE WAS MILD SURROUNDING EDEMA. THERE WAS NO SIGNIFICANT MASS EFFECT SEEN. A PHYSICIAN NOTE DOCUMENTED THAT THE PATIENT WAS EXPERIENCING A SEVERE HEADACHE. BETTER BLOOD PRESSURE CONTROL WAS RECOMMENDED. A HEAD CT WITHOUT CONTRAST WAS PERFORMED ON AND COMPARED TO THE (B)(4) 2013 STUDY. THE IMPRESSION WAS: SIMILAR APPEARANCE OF THE LEFT TEMPORAL LOBE HEMORRHAGE RELATIVE TO (B)(6) 2013. A CAROTID ULTRASOUND WAS PERFORMED AND COMPARED TO THE EXAM ON (B)6) 2013. THE IMPRESSION WAS: PATENT BILATERAL INTERNAL CAROTID ARTERY STENTS. THE NEUROLOGICAL EXAMINATION ON (B)(6) 2013 WAS WITHIN NORMAL LIMITS EXCEPT FOR MILDLY ABNORMAL LANGUAGE WITH IMPAIRED READING AND NAMING, SOME ELEMENTS OF PERSEVERATION AND SUBTLE RIGHT PRONATION AND DRIFT. A HEAD CT ON FIFTEEN DAYS POST-PROCEDURE SHOWED: 1. DECREASED DENSITY OF THE LEFT POSTERIOR TEMPORAL HEMATOMA, CONSISTENT WITH MILD IMPROVEMENT. 2. NO OTHER ACUTE ABNORMALITY. THE SURGEON'S NEUROLOGICAL EXAMINATION DOCUMENTED THAT THE PATIENT WAS ALERT AND ORIENTED WITH NO FOCAL DEFICITS. NO NEUROLOGY CONSULT NOTES WERE RECEIVED AND A DISCHARGE SUMMARY WAS NOT PROVIDED. THE DISCHARGE DATE IS UNKNOWN. THE 30-DAY FOLLOW-UP VISIT WAS COMPLETED. THE STROKE SCALE SCORES WERE EVALUATED BY A DIFFERENT EXAMINER. THE NIH STROKE SCALE SCORE WAS 0 AND THE RANKIN SCORE WAS 0. THE PATIENT WAS TAKING ASA AND CLOPIDOGREL.

    Additional Manufacturer Narrative · 1

    AS REPORTED, THE PATIENT HAD A PRECISE 7 X 40 STENT SUCCESSFULLY IMPLANTED IN THE OSTIAL LEFT INTERNAL CAROTID ARTERY (LICA) DURING THE STUDY INDEX PROCEDURE. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS, DEVICE DEVIATIONS OR ADVERSE EVENTS REPORTED PRIOR TO DISCHARGE. THE PATIENT HAD NO NEUROLOGICAL DEFICIT UPON LEAVING THE ANGIOGRAPHY SUITE POST-PROCEDURE. THE PATIENT WAS DISCHARGED THE DAY AFTER THE PROCEDURE. TWO DAYS AFTER DISCHARGE/THREE DAYS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED AN ADVERSE EVENT (AE) OF SUBARACHNOID HEMORRHAGE/STROKE CHARACTERIZED BY LEFT HEMIPARESIS AND ¿OTHER¿ NEUROLOGICAL DEFICIT OPTIONS. THE PATIENT EXPERIENCED SEVERE HEADACHE, LEFT FACE PARASTHESIA, AND DIFFICULTY READING. THE PATIENT WAS RE-ADMITTED. NO TREATMENT WAS PROVIDED OTHER THAN HOLDING OF ANTIPLATELET THERAPY AND ADJUSTMENT OF MEDICATIONS. THE ONSET OF THE EVENT WAS SUDDEN. THE EVENT LASTED LESS THAN TWENTY-FOUR HOURS (>24 HOURS). THE PATIENT RECOVERED IN FULL WITH NO RESIDUALS. NO INTERVENTION/EMERGENT CEA SURGERY WAS REQUIRED. THE EVENT WAS REPORTED TO BE UNRELATED TO A CORDIS PRODUCT OR ANTICOAGULATION AND WAS RELATED TO THE STUDY PROCEDURE. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR INSPECTION. 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 15720925 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. BASED ON THE INFORMATION PROVIDED AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. SUBARACHNOID HEMORRHAGE OCCURS WHEN A BLOOD VESSEL JUST OUTSIDE THE BRAIN RUPTURES. THE AREA OF THE SKULL SURROUNDING THE BRAIN (THE SUBARACHNOID SPACE) RAPIDLY FILLS WITH BLOOD. A PATIENT WITH SUBARACHNOID HEMORRHAGE MAY HAVE A SUDDEN, INTENSE HEADACHE, NECK PAIN, AND NAUSEA OR VOMITING. SOMETIMES THIS IS DESCRIBED AS THE WORST HEADACHE OF ONE'S LIFE. THE SUDDEN BUILDUP OF PRESSURE OUTSIDE THE BRAIN MAY ALSO CAUSE RAPID LOSS OF CONSCIOUSNESS OR DEATH. SUBARACHNOID HEMORRHAGE IS MOST OFTEN CAUSED BY ABNORMALITIES OF THE ARTERIES AT THE BASE OF THE BRAIN, CALLED CEREBRAL ANEURYSMS. THESE ARE SMALL AREAS OF ROUNDED OR IRREGULAR SWELLINGS IN THE ARTERIES. WHERE THE SWELLING IS MOST SEVERE, THE BLOOD VESSEL WALL BECOMES WEAK AND PRONE TO RUPTURE. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS AND/OR VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT. BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT WAS DESIGN OR MANUFACTURING RELATED THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE (B)(6) STUDY INDICATED THAT THE PATIENT WAS ENROLLED IN THE STUDY AND HAD A PRECISE 7 X 40 STENT SUCCESSFULLY IMPLANTED IN THE OSTIAL LEFT INTERNAL CAROTID ARTERY (LICA) DURING THE STUDY INDEX PROCEDURE. A 5 MM. ANGIOGUARD WAS USED FOR THE PROCEDURE. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS, DEVICE DEVIATIONS OR ADVERSE EVENTS REPORTED PRIOR TO DISCHARGE. THE PATIENT HAD NO NEUROLOGICAL DEFICIT UPON LEAVING THE ANGIOGRAPHY SUITE POST-PROCEDURE. THE PATIENT WAS DISCHARGED THE DAY AFTER THE PROCEDURE. TWO DAYS AFTER DISCHARGE/THREE DAYS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED AN ADVERSE EVENT (AE) OF SUBARACHNOID HEMORRHAGE/STROKE CHARACTERIZED BY LEFT HEMIPARESIS AND ¿OTHER¿ NEUROLOGICAL DEFICIT OPTIONS. THE PATIENT EXPERIENCED SEVERE HEADACHE, LEFT FACE PARASTHESIA, AND DIFFICULTY READING. THE PATIENT WAS RE-ADMITTED. NO TREATMENT WAS PROVIDED OTHER THAN HOLDING OF ANTIPLATELET THERAPY AND ADJUSTMENT OF MEDICATIONS. THE ONSET OF THE EVENT WAS SUDDEN. THE EVENT LASTED LESS THAN TWENTY-FOUR HOURS (>24 HOURS). THE PATIENT RECOVERED IN FULL WITH NO RESIDUALS. NO INTERVENTION/EMERGENT CEA SURGERY WAS REQUIRED. THE EVENT WAS REPORTED TO BE UNRELATED TO A CORDIS PRODUCT OR ANTICOAGULATION AND WAS RELATED TO THE STUDY PROCEDURE. THE OSTIAL LICA TARGET LESION WAS REPORTED TO BE: A 90% STENOSIS, ABSENT OF THROMBUS, 4 MM. REFERENCE DIAMETER, AND NOT CALCIFIED/TORTUOUS. THE LESION WAS NOT PRE-DILATED. THE RESIDUAL STENOSIS WAS 0%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324302 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 15720925

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L 5 MM ANGIOGUARD