BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 1984586 · Received February 11, 2011

    Report

    Report Number
    1016427-2011-00013
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 18, 2011
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS DISCHARGED TO A REHABILITATION FACILITY APPROXIMATELY FIVE DAYS AFTER THE INDEX PROCEDURE WITH NIH STROKE SCALE SCORE AND RANKIN SCORE OF 3. ACCORDING TO THE INVESTIGATOR, THE STROKE WAS RELATED TO THE INDEX PROCEDURE AND NOT CORDIS PRODUCT. CONCOMITANT PRODUCTS/MEDICATIONS: 8.0 X 30MM PRECISE PRO RX, 5MM AVIATOR PLUS, ASPIRIN, CLOPIDOGREL, HEPARIN. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9610978-2011-00031, 1016427-2011-00013 AND 9616099-2011-00095. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    AS REPORTED VIA THE (B)(4) REGISTRY THE PATIENT EXPERIENCED AN ISCHEMIC STROKE DURING POST-DILATION OF THE STENT. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 70% STENOSIS OF THE LEFT PROXIMAL INTERNAL CAROTID ARTERY. THE LESION WAS 15MM IN LENGTH, ECCENTRIC AND MODERATELY CALCIFIED. THE REFERENCE VESSEL WAS 6MM IN DIAMETER WITH SEVERE TORTUOSITY AND A TYPE II ARCH. THE PATIENT HAD A PRIOR TRANSIENT ISCHEMIC ATTACK (TIA) WITH WEAKNESS ON THE RIGHT PRIOR TO THE PROCEDURE, HOWEVER THE RANKIN AND NIH STROKE SCALE SCORES WERE 0. AN ANGIOGUARD RX WAS DEPLOYED BEYOND THE TARGET LESION AND THE LESION WAS PRE-DILATED FOLLOWED BY IMPLANTATION OF AN 8.0 X 30MM PRECISE PRO RX. DURING POST-DILATION WITH A 5MM AVIATOR PLUS BALLOON, THE PATIENT EXPERIENCED SUDDEN ONSET OF AN ISCHEMIC STROKE. THE SYMPTOMS OF THE STROKE INCLUDED EXPRESSIVE APHASIA, REFLEX CHANGE, AND RIGHT HEMIPARESIS. THE PATIENT HAD A PARTIAL RECOVERY WITH MINOR RESIDUAL. THERE WAS NO DEBRIS IN THE ANGIOGUARD BASKET WHEN THE DEVICE WAS RETRIEVED. THE PATIENT WAS DISCHARGED TO A REHABILITATION FACILITY APPROXIMATELY FIVE DAYS AFTER THE INDEX PROCEDURE WITH NIH STROKE SCALE SCORE AND RANKIN SCORE OF 3. ACCORDING TO THE INVESTIGATOR, THE STROKE WAS RELATED TO THE INDEX PROCEDURE AND NOT CORDIS PRODUCT. THE PATIENT'S MEDICAL HISTORY INCLUDES CLINICAL COPD, ABNORMAL STRESS TEST, HISTORY OF SMOKING, DIABETES MELLITUS, CORONARY ARTERY DISEASE, CORONARY PERCUTANEOUS REVASCULARIZATION AND TRANSIENT ISCHEMIC ATTACK (TIA). THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. 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. AS ENDORSED BY 2009 GUIDELINES FROM THE AMERICAN HEART ASSOCIATION AND AMERICAN STROKE ASSOCIATION (AHA/ASA) ISCHEMIC STROKE IS DEFINED AS AN INFRACTION OF CENTRAL NERVOUS SYSTEM TISSUE. 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, THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT, VESSEL AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9610978-2011-00031, 1016427-2011-00013 AND 9616099-2011-00095.

    Description of Event or Problem · 1

    AS REPORTED VIA THE (B)(4) REGISTRY, AN ANGIOGUARD RX DID NOT TRACK TO THE LESION AND THE PATIENT EXPERIENCED AND ISCHEMIC STROKE DURING POST-DILATION OF THE STENT. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 70% STENOSIS OF THE LEFT PROXIMAL INTERNAL CAROTID ARTERY. THE LESION WAS 15MM IN LENGTH, ECCENTRIC AND MODERATELY CALCIFIED. THE REFERENCE VESSEL WAS 6MM IN DIAMETER WITH SEVERE TORTUOSITY AND A TYPE II ARCH. THE PATIENT HAD A PRIOR TRANSIENT ISCHEMIC ATTACK (TIA) WITH WEAKNESS ON THE RIGHT PRIOR TO THE PROCEDURE, HOWEVER THE RANKIN AND NIH STROKE SCALE SCORES WERE 0. AN INITIAL 6MM ANGIOGUARD RX WAS UNABLE TO TRACK TO THE LESION, AND WAS REMOVED WITHOUT INJURY TO THE PATIENT. A SECOND 6MM ANGIOGUARD RX WAS DEPLOYED BEYOND THE TARGET LESION AND THE LESION WAS PRE-DILATED. AN 8.0 X 30MM PRECISE PRO RX WAS IMPLANTED AT THE TARGET LESION. DURING POST-DILATION WITH A 5MM AVIATOR PLUS BALLOON (LOT UNKNOWN) AT 8ATM, THE PATIENT EXPERIENCED THE SUDDEN ONSET OF AN ISCHEMIC STROKE. THE SYMPTOMS OF THE STROKE INCLUDED EXPRESSIVE APHASIA, REFLEX CHANGE, AND RIGHT HEMIPARESIS. THE PATIENT HAD A PARTIAL RECOVERY WITH MINOR RESIDUAL. THERE WAS NO DEBRIS IN THE ANGIOGUARD BASKET WHEN THE DEVICE WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM EMBOLIC PROTECTION DEVICE (NTE) NTE CORDIS CORPORATION NA 71010512

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Disability