BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 3082121 · Received April 29, 2013

    Report

    Report Number
    9616099-2013-00258
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    March 31, 2013
    Report Date
    April 3, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE RIGHT PROXIMAL INTERNAL CAROTID ARTERY WAS THE TREATED AREA, NOT THE RIGHT PROXIMAL EXTERNAL ARTERY. PLEASE UPDATE YOUR FILE. PER THE CEC ADJUDICATION COMMITTEE AGREED THAT THE STROKE WAS PROCEDURE RELATED. THE EVENT REQUIRED HOSPITAL ADMISSION AND RESIDUAL DEFICITS. COMPLAINT CONCLUSION UPDATED: THIS (B)(6) MALE ENROLLED IN THE SAPPHIRE REGISTRY EXPERIENCED AN ISCHEMIC STROKE FOUR DAYS POST PROCEDURE. PRE-PROCEDURE NIH STROKE SCALE WAS 0 AND THE STROKE SCALE WAS 0. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 85% STENOSIS TO THE RIGHT INTERNAL CAROTID ARTERY. THE PATIENT WAS ASYMPTOMATIC. THE LESION WAS DESCRIBED AS 15MM IN LENGTH, CONCENTRIC, ARCH TYPE I, ECCENTRIC AND MILDLY CALCIFIED. THE REFERENCE VESSEL WAS 5.0 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 SUCCESSFULLY AND DEBRIS WAS NOT NOTED IN THE FILTER BASKET. THERE WAS 10% RESIDUAL STENOSIS. THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITH NO NEUROLOGICAL DEFICITS. THE PATIENT WAS DISCHARGED THE NEXT DAY WITH A POST NIH STROKE SCALE OF 0 AND THE STROKE SCALE OF 0. CONCOMITANT MEDICATIONS INCLUDED CLOPIDOGREL AND ASPIRIN AT PRE PROCEDURE AND AT DISCHARGE. THEN, FOUR DAYS POST PROCEDURE ON ((B)(6) 2013) THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH A COMPLAINT OF DIZZINESS AND FATIGUE WHICH BEGAN 3 DAYS PREVIOUSLY. THE PATIENT DESCRIBED THE DIZZINESS AS "SPELLS OF EVERYTHING SPINNING" LASTING 1 HOUR. HE HAD DIZZINESS IN THE PAST, BUT IT HAD INCREASED RECENTLY. HE ALSO HAD MILD NUMBNESS OF THE RIGHT HAND/FOREARM IN THE PAST WHICH HAD INCREASED 3 DAYS PREVIOUSLY POST CAROTID STENTING. HE DESCRIBED SPEECH DIFFICULTY AS CONFUSION. AFTER AMBULATORY PRIOR TO DISPOSITION, THE PATIENT BECAME VERY LIGHTHEADED WITH VERTIGO. HIS BLOOD SUGAR WAS CHECKED AND WAS CRITICALLY LOW. HE REMAINED ALERT AND ORIENTED X 3. HE WAS GIVEN A MEAL AND FLUIDS BY MOUTH AS THE IV WAS COMPLETED. THE PATIENT WAS RECHECKED AND REMAINED LIGHTHEADED DESPITE A BLOOD SUGAR OF 99. A SECOND DOSE OF MECLIZINE WAS GIVEN; THE PATIENT REMAINED LIGHTHEADED AND WAS NERVOUS ABOUT GOING HOME. IT WAS DECIDED TO ADMIT THE PATIENT TO THE HOSPITAL. ON (B)(6) 2013, A CT OF THE HEAD WITHOUT CONTRAST WAS PERFORMED. THE CLINICAL INDICATION WAS INCREASING VERTIGO AND LIGHTHEADEDNESS. THE CT REVEALED THE FOLLOWING: THE VENTRICLES ARE MIDLINE IN LOCATION. THE GRAY-WHITE MATTER DIFFERENTIATION APPEARS NORMAL. NO EXTRA-AXIAL COLLECTIONS OF BLOOD OR FLUID ARE DETECTED. SMALL LACUNAR INFARCT OR PROMINENT VASCULAR SPACE IS NOTED WITHIN THE RIGHT THALAMIC REGION. MINIMAL VALUE AREAS OF DECREASED ATTENUATION ARE NOTED WITHIN THE PERIVENTRICULAR WHITE MATTER. NO MASS LESION OR EVIDENCE FOR ACUTE INFARCTION ARE NOTED. THE MASTOID AIR CELLS AND PARANASAL SINUSES ARE WELL-AERATED. ON (B)(6) 2013, THE NEUROLOGY CONSULTATION NOTE DOCUMENTED THAT THE PATIENT HAD EXPERIENCED A SENSATION THAT THE ROOM WAS SPINNING WHEN IN THE SHOWER THE DAY BEFORE; HE HAD NEVER EXPERIENCED THIS SENSATION PREVIOUSLY. HE ALSO HAD DIFFICULTY WALKING AND FELT LIKE HIS VISION WAS DIFFERENT, BUT COULD NOT DESCRIBE ANY FURTHER. THE NEUROLOGICAL EXAMINATION REVEALED SOME IN-COORDINATION OF THE LEFT HAND WITH FINGER-TO-NOSE TESTING. THE PATIENT ALSO EXPERIENCED VERTIGO WHEN WALKING WITH THE PHYSICAL THERAPIST. MECLAZINE WAS INCREASE TO 25 MG T.I.D. ON (B)(6) 2013, THE PATIENT WAS TRANSFERRED TO A REHABILITATION CENTER. IT WAS NOTED THAT THE PATIENT HAD NOT FELT RIGHT SINCE THE CAROTID STENTING. ON (B)(6) 2013, A NEUROLOGY FOLLOW-UP CONSULT NOTED THAT THE PATIENT'S STROKES WERE LIKELY CARDIOEMBOLIC IN LIGHT OF THE LOW FLOW AND SMOKE SEEN ON THE TRANSESOPHAGEAL ECHOCARDIOGRAM AND CONSIDERING THE STROKES WERE BILATERAL AND INVOLVED THE POSTERIOR CIRCULATION. THE PATIENT WAS STARTED ON WARFARIN AND CONTINUED ON CLOPIDOGREL. ASA WOULD LIKELY BE DISCONTINUED-NEUROLOGY DEFERRED TO CARDIOLOGY. ON (B)(6) 2013, THE 30-DAY FOLLOW-UP VISIT WAS COMPLETED. THE NIH STROKE SCALE SCORE WAS 2 AND THE RANKIN SCORE WAS 3. PER THE CEC STUDY ADJUDICATION MINUTES, THE COMMITTEE AGREED THAT THE CVA ¿ BILATERAL MINOR WAS PROCEDURE RELATED. THE PATIENT¿S MEDICAL HISTORY INCLUDES FIRST-DEGREE RELATIVE WITH PREMATURE CAD, HYPERLIPIDEMIA, COPD, SMOKING, DIABETES MELLITUS, MYOCARDIAL INFARCTION, CORONARY PERCUTANEOUS REVASCULARIZATION AND HYPERTENSION (SYSTOLIC>140, OR DIASTOLIC>90, OR REQUIRING MEDICATION). HIGH RISK CRITERIA: AGE > 75. THE PRODUCT REMAINS IMPLANTED AND IS, THEREFORE, NOT UNAVAILABLE 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. ISCHEMIC STROKE 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. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED THE REPORTED FAILURE/EVENT DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: AS REPORTED VIA (B)(6), A PATIENT EXPERIENCED AN ISCHEMIC STROKE FOUR DAYS POST PROCEDURE. PRE-PROCEDURE NIH STROKE SCALE WAS 0 AND THE STROKE SCALE WAS 0. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 85% STENOSIS TO THE RIGHT PROXIMAL CAROTID ARTERY. THE PATIENT WAS ASYMPTOMATIC. THE LESION WAS DESCRIBED AS 15MM IN LENGTH, CONCENTRIC, ARCH TYPE I, ECCENTRIC AND MILDLY CALCIFIED. THE REFERENCE VESSEL WAS 5.0 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 SUCCESSFULLY AND DEBRIS WAS NOT NOTED IN THE FILTER BASKET. THERE WAS 10% RESIDUAL STENOSIS. THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITH NO NEUROLOGICAL DEFICITS. THE PATIENT WAS DISCHARGED THE NEXT DAY WITH A POST NIH STROKE SCALE OF 0 AND THE STROKE SCALE OF 0. CONCOMITANT MEDICATIONS INCLUDED CLOPIDOGREL AND ASPIRIN AT PRE PROCEDURE AND AT DISCHARGE. THEN, FOUR DAYS POST PROCEDURE THE PATIENT EXPERIENCED A NEUROLOGICAL EVENT. THE EVENT WAS SUDDEN AND THE DURATION AND RECOVERY IS UNKNOWN. THE EVENT WAS CLASSIFIED AS AN ISCHEMIC STROKE. PER THE INVESTIGATOR IT WAS NOT RELATED TO THE PROCEDURE OR THE CORDIS DEVICE. THE PATIENT¿S MEDICAL HISTORY INCLUDES FIRST-DEGREE RELATIVE WITH PREMATURE CAD, HYPERLIPIDEMIA, COPD, SMOKING, DIABETES MELLITUS, MYOCARDIAL INFARCTION, CORONARY PERCUTANEOUS REVASCULARIZATION AND HYPERTENSION (SYSTOLIC>140, OR DIASTOLIC>90, OR REQUIRING MEDICATION). HIGH RISK CRITERIA: AGE > (B)(6). THE PRODUCT REMAINS IMPLANTED AND IS, THEREFORE, NOT UNAVAILABLE 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. ISCHEMIC STROKE 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. EIGHTY PERCENT 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. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED THE REPORTED FAILURE/EVENT DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED VIA THE SAPPHIRE REGISTRY, A PATIENT EXPERIENCED AN ISCHEMIC STROKE FOUR DAYS POST PROCEDURE. PRE-PROCEDURE NIH STROKE SCALE WAS 0 AND THE STROKE SCALE WAS 0. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 85% STENOSIS TO THE RIGHT PROXIMAL CAROTID ARTERY. THE PATIENT WAS ASYMPTOMATIC. THE LESION WAS DESCRIBED AS 15MM IN LENGTH, CONCENTRIC, ARCH TYPE I, ECCENTRIC AND MILDLY CALCIFIED. THE REFERENCE VESSEL WAS 5.0 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 SUCCESSFULLY AND DEBRIS WAS NOT NOTED IN THE FILTER BASKET. THERE WAS 10% RESIDUAL STENOSIS. THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITH NO NEUROLOGICAL DEFICITS. THE PATIENT WAS DISCHARGED THE NEXT DAY WITH A POST NIH STROKE SCALE OF 0 AND THE STROKE SCALE OF 0. CONCOMITANT MEDICATIONS INCLUDED CLOPIDOGREL AND ASPIRIN AT PRE PROCEDURE AND AT DISCHARGE. THEN, FOUR DAYS POST PROCEDURE THE PATIENT EXPERIENCED A NEUROLOGICAL EVENT. THE EVENT WAS SUDDEN AND THE DURATION AND RECOVERY IS UNKNOWN. THE EVENT WAS CLASSIFIED AS AN ISCHEMIC STROKE. PER THE INVESTIGATOR IT WAS NOT RELATED TO THE PROCEDURE OR THE CORDIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184516 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 15667715

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| L| S