BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1936168 · Received December 22, 2010

    Report

    Report Number
    9616099-2010-01017
    Event Type
    Death
    Date Received
    December 22, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 29, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Additional Manufacturer Narrative · 1

    AS REPORTED BY (B)(6), APPROXIMATELY A MONTH POST INDEX PROCEDURE THE PATIENT EXPERIENCED HEMIPARESIS ON THE LEFT SIDE, ONSET WAS GRADUAL, DIAGNOSIS WAS AN ISCHEMIC STROKE. THE EVENT WAS EVALUATED AND DETERMINED TO BE UNRELATED TO THE INDEX PROCEDURE AND UNRELATED TO THE CORDIS PRODUCT. EIGHT MONTHS POST-PROCEDURE, THE PATIENT EXPIRED. THE CAUSE OF DEATH IS UNKNOWN. THE EVENT WAS EVALUATED AND DETERMINED TO BE UNRELATED TO THE INDEX PROCEDURE AND UNRELATED TO THE CORDIS PRODUCT. THE PATIENT'S MEDICAL HISTORY INCLUDES HYPERLIPIDEMIA, CABG, HISTORY OF SMOKING, DIABETES MELLITUS, CORONARY ARTERY DISEASE AND HYPERTENSION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION. HOWEVER, NO ADDITIONAL INFORMATION REGARDING PATIENT, LESION OR PROCEDURAL CHARACTERISTICS REGARDING THIS EVENT HAS BEEN PROVIDED. 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 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. ISCHEMIC 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. THE REPORTED DEATH OF THE PATIENT DUE TO UNKNOWN CAUSES APPROXIMATELY EIGHT MONTHS AFTER THE STENT WAS IMPLANTED IN THE CAROTID ARTERY IS A KNOWN POTENTIAL COMPLICATION TO ANY INVASIVE PROCEDURE. THE CAUSE OF THE DEATH WAS UNKNOWN AND MAY HAVE BEEN RELATED TO THE PATIENTS MANY RISK FACTORS AND RELEVANT MEDICAL HISTORY. 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

    AS REPORTED BY THE (B)(6) REGISTRY, APPROXIMATELY A MONTH POST INDEX PROCEDURE, THE PATIENT WAS DIAGNOSED WITH AN ISCHEMIC STROKE. EIGHT MONTHS POST-PROCEDURE, THE PATIENT EXPIRED. THE CAUSE OF DEATH IS UNKNOWN. THE PATIENT IS A AN (B)(6) FEMALE WHO WAS ENROLLED IN THE (B)(6) STUDY FOR STENTING OF THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY. THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2009. THE RATE OF STENOSIS IS 86%. AN ANGIOGUARD (601814RMC / LOT 70209537) DISTAL PROTECTION DEVICE WAS DEPLOYED DISTAL IN THE VESSEL AND THE LESION WAS PRE-DILATED. A PRECISE (PC0730RXC/ LOT 14003079) STENT WAS DEPLOYED IN THE LESION. THERE WAS NO MALFUNCTION WITH THE STENT. THE ANGIOGUARD WAS SUCCESSFULLY RETRIEVED. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE. THE PATIENT WAS DISCHARGED THREE DAYS LATER. APPROXIMATELY ONE MONTH POST INDEX PROCEDURE, THE PATIENT EXPERIENCED HEMIPARESIS ON THE LEFT SIDE. ONSET WAS GRADUAL. DIAGNOSIS WAS A STROKE. THE EVENT WAS EVALUATED AND DETERMINED TO BE UNRELATED TO THE INDEX PROCEDURE AND UNRELATED TO THE CORDIS PRODUCT. APPROXIMATELY EIGHT MONTHS POST PROCEDURE, THE PATIENT EXPIRED. THE CAUSE OF DEATH IS UNKNOWN. THE EVENT WAS EVALUATED AND DETERMINED TO BE UNRELATED TO THE INDEX PROCEDURE AND UNRELATED TO THE CORDIS PRODUCT.

    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 14003079

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death ANGIOGUARD DISTAL PROTECTION DEVICE.