BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1935263 · Received December 22, 2010

    Report

    Report Number
    9616099-2010-01014
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    November 29, 2010
    Report Date
    December 3, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2010-01014 AND 1016427-2010-00155. ADDITIONAL INFORMATION WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2010-01014 AND 1016427-2010-00155. THE PATIENT WAS ENROLLED IN THE (B)(4) STUDY WITH AN 80%, ECCENTRIC, ULCERATED AND MILDLY CALCIFIED LESION IN THE DISTAL LEFT INTERNAL CAROTID ARTERY. THE LESION WAS 10MM IN LENGTH AND THE VESSEL WAS 6MM IN DIAMETER. THE LESION WAS PRE-DILATED. AN ANGIOGUARD WAS PLACED AND A PRECISE STENT WAS SUCCESSFULLY IMPLANTED. THE FINAL PERCENTAGE OF STENOSIS WAS 10%. DEBRIS WAS NOTED IN THE FILTER BASKET UPON REMOVAL OF THE DEVICE. DURING THE PROCEDURE IT WAS NOTED THAT THE PATIENT EXPERIENCED A NEUROLOGICAL DEFICIT. THE PATIENT WAS DIAGNOSED WITH A STROKE. THE PATIENT HAD APHASIA AND REFLEX CHANGES. THE PATIENT ALSO HAD RIGHT HEMIPARESIS. THE ONSET WAS SUDDEN AND THE PATIENT'S RECOVERY WAS PARTIAL WITH MINOR RESIDUALS. THIS EVENT WAS DEEMED TO BE UNRELATED TO THE DEVICE, HOWEVER, RELATED TO THE PROCEDURE. THE PATIENT'S MEDICAL HISTORY INCLUDED HISTORY OF SYNCHRONOUS, SEVERE CARDIAC AND CAROTID DISEASE REQUIRING OPEN-HEART SURGERY AND CAROTID REVASCULARIZATION, HYPERLIPIDEMIA, DIABETES MELLITUS, CORONARY ARTERY DISEASE, MYOCARDIAL INFARCTION AND HYPERTENSION. HIGH RISK CRITERIA INCLUDED RECENT MI (GREATER THAN 24HRS. AND LESS THAN 6WEEKS), AGE > 75, KNOWLEDGE OF TWO OR MORE PROXIMAL OR MAJOR DISEASED CORONARY ARTERIES WITH > 70% STENOSIS THAT HAVE NOT OR CANNOT BE REVASCULARIZED. 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 15222348 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. BASED ON THE LACK OF INFORMATION, AND THE INABILITY TO ASSIGN OR DETERMINE ROOT CAUSE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE FUNCTION OF AN EMBOLIC PROTECTION DEVICE IS TO CAPTURE DEBRIS DURING THE CAROTID PROCEDURE AND PREVENT IT FROM EMBOLIZING DOWNSTREAM INTO THE PATIENTS VASCULATURE. IF ENOUGH DEBRIS IS DISLODGED FROM THE ARTERIAL WALL DURING THE PROCEDURE IT MAY FILL THE FILTER BASKET TO THE POINT AT WHICH IT INTERFERES WITH NORMAL BLOOD FLOW THROUGH THE FILTER RESULTING IN HYPOPERFUSION. THIS IS AN INHERENT RISK OF THE PROCEDURE AND DOES NOT REPRESENT A DEVICE MALFUNCTION. NORMAL BLOOD FLOW RESUMES UPON REMOVAL OF THE DEVICE OR REMOVAL OF THE DEBRIS IN THE FILTER BY MEANS OF AN ASPIRATION CATHETER. STROKE IS A KNOWN POTENTIAL RISK ASSOCIATED WITH IMPLANTING A STENT IN A CAROTID ARTERY AND 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.

    Description of Event or Problem · 1

    DURING THE PROCEDURE IT WAS NOTED THAT THE PATIENT EXPERIENCED A NEUROLOGICAL DEFICIT. THE PATIENT WAS DIAGNOSED WITH A STROKE. THE PATIENT HAD APHASIA AND REFLEX CHANGES. THE PATIENT ALSO HAD RIGHT HEMIPARESIS. THE ONSET WAS SUDDEN AND THE PATIENT'S RECOVERY WAS PARTIAL WITH MINOR RESIDUALS. THIS EVENT WAS DEEMED TO BE UNRELATED TO THE DEVICE, HOWEVER, RELATED TO THE PROCEDURE. APPROXIMATELY EIGHT DAYS POST INDEX PROCEDURE THE PATIENT DIED. THE CAUSE OF DEATH WAS NOTED TO BE CONGESTIVE HEART FAILURE. THIS EVENT WAS DEEMED TO BE UNRELATED TO THE DEVICE. THE PATIENT WAS ENROLLED IN THE (B)(4) STUDY WITH AN 80%, ECCENTRIC, ULCERATED AND MILDLY CALCIFIED LESION IN THE DISTAL LEFT INTERNAL CAROTID ARTERY. THE LESION WAS 10MM IN LENGTH AND THE VESSEL WAS 6MM IN DIAMETER. THE LESION WAS PRE-DILATED. AN ANGIOGUARD WAS PLACED AND A PRECISE STENT WAS SUCCESSFULLY IMPLANTED. THE FINAL PERCENTAGE OF STENOSIS WAS 10%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 15222348

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention