BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOGUARD RX

    MDR report key: 1714135 · Received June 9, 2010

    Report

    Report Number
    1016427-2010-00064
    Event Type
    Injury
    Date Received
    June 9, 2010
    Date of Event
    May 17, 2010
    Report Date
    May 18, 2010
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S DISCHARGE RECORD WAS RECEIVED THAT THE NIH STROKE SCALE SCORE WAS 4. PRE AND POST-PROCEDURE MEDICATIONS INCLUDED ASPIRIN AND CLOPIDOGREL. HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1016427-2010-00064 AND 9616099-2010-00444.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. CONCOMITANT DEVICES INCLUDE 6MM ANGIOGUARD RX. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1016427-2010-00064 AND 9616099-2010-00444. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1016427-2010-00064 AND 9616099-2010-00444.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1016427-2010-00064 AND 9616099-2010-00444. THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS; HOWEVER, A REVIEW OF THE MANUFACTURING DOCUMENTATION PRESENTED NO ISSUES OR ANOMALIES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DID NOT HAVE ANY ALLERGIES TO NITINOL, NICKEL, OR TITANIUM. THE PATIENT HAD A HISTORY OF STROKE AND TRANSIENT ISCHEMIC ATTACK. A 7FR ARROW SHEATH WAS USED. THERE WAS A TIGHT SEAL BETWEEN THE STENT DELIVERY SYSTEM AND THE TOUGHY BORST (HEMOSTATIS) VALVE OF THE SHEATH INTRODUCER/GUIDING CATHETER DURING ASPIRATION. THE INVESTIGATOR ASPIRATED PRIOR TO EACH FLUSH AND INJECTION. THERE WAS NO THROMBUS PRE OR POST-DEPLOYMENT. THE STROKE WAS ON THE RIGHT SIDE OF THE BRAIN. THE PATIENT DEVELOPED LEFT NEGLECT AND HEMIPLEGIA. A CT SCAN WAS OBTAINED AND A WEIGHT BASED LOADING DOSE OF REOPRO. A NEUROLOGIST CONSULTATION WAS DONE AND THE STROKE WAS RESOLVING FROM AN INITIAL NIH OF 11 TO 4. NO FURTHER TREATMENT WAS GIVEN. AS REPORTED BY (B)(4) REGISTRY, THE PATIENT EXPERIENCED A STROKE DURING THE INDEX PROCEDURE. MEDICAL HISTORY INCLUDES TRANSIENT ISCHEMIC ATTACK, STROKE, SIGNIFICANT AORTIC ARCH DISEASE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, SMOKING, AND DIABETES MELLITUS, PREVIOUS CAROTID ENDARTERECTOMY, AND RECURRENT STENOSIS. THE TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT INTERNAL CAROTID ARTERY. THE LESION WAS DESCRIBED AS 80% STENOSED, 10MM IN LENGTH, ECCENTRIC, WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS MODERATELY TORTUOUS AND 5.0MM IN DIAMETER. THE LESION WAS PRE-DILATED WITH AN UNKNOWN BALLOON AND A 6MM ANGIOGUARD RX WAS SUCCESSFULLY DEPLOYED BEYOND THE TARGET LESION. AN 8X40MM PRECISE PRO RX STENT WAS SUCCESSFULLY IMPLANTED. THE ANGIOGUARD RX WAS RETRIEVED WITH NO DEBRIS NOTED IN THE BASKET. WHEN THE ANGIOGUARD RX WAS REMOVED FROM THE PATIENT, THE PATIENT EXPERIENCED BEHAVIORAL CHANGES, APHASIA, REFLEX CHANGES, AND LEFT-SIDED HEMINEGLECT. THE PATIENT WAS DIAGNOSED WITH AN ISCHEMIC STROKE. THE PATIENT'S RECOVERY WAS PARTIAL WITH MINOR RESIDUALS. THERE WERE NO AIR BUBBLES NOTED AT ANY TIME DURING THE PROCEDURE. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO CORDIS PRODUCT. THE INVESTIGATOR FELT THE EVENT WAS RELATED TO THE INDEX PROCEDURE. THE DAY AFTER THE INDEX PROCEDURE, THE PATIENT WENT TO SURGERY FOR A PSEUDOANEURYSM OF THE GROIN PUNCTURE SITE. NOTE: LAKE REGION LOT NUMBER (B)(4) IS CORDIS LOT NUMBER (B)(4). PER LAKE REGION REPORT (B)(4): LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT (B)(4). THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. ACTION TAKEN: NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED THE REPORTED FAILURE DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. ISCHEMIC STROKE IS A KNOWN POTENTIAL RISK ASSOCIATED WITH IMPLANTING A STENT IN A CAROTID ARTERY. THE ACT OF POST-DILATATION, TO OPTIMALLY OPPOSE A CAROTID STENT TO THE VESSEL WALL, TEMPORARILY OBSTRUCTS BLOOD FLOW TO THE CEREBRAL ARTERIES (ISCHEMIC PROCESS). STROKE IS ASSOCIATED WITH A STOPPAGE OR SLOWING OF BLOOD FLOW TO THE CEREBRAL ARTERIES. 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. THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT IS RELATED TO THE DESIGN OR MANUFACTURING PROCESS OF THE DEVICE. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1016427-2010-00064 AND 9616099-2010-00444.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(4) REGISTRY, THE PATIENT EXPERIENCED A STROKE DURING THE INDEX PROCEDURE. THE TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT INTERNAL CAROTID ARTERY. THE LESION WAS DESCRIBED AS 80% STENOSED, 10MM IN LENGTH, ECCENTRIC, WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS MODERATELY TORTUOUS AND 5.0MM IN DIAMETER. THE LESION WAS PRE-DILATED WITH AN UNKNOWN BALLOON AND A 6MM ANGIOGUARD RX WAS SUCCESSFULLY DEPLOYED BEYOND THE TARGET LESION. AN 8X40MM PRECISE PRO RX STENT WAS SUCCESSFULLY IMPLANTED. THE ANGIOGUARD RX WAS RETRIEVED WITH NO DEBRIS NOTED IN THE BASKET. WHEN THE ANGIOGUARD RX WAS REMOVED FROM THE PATIENT, THE PATIENT EXPERIENCED BEHAVIORAL CHANGES, APHASIA, REFLEX CHANGES, AND LEFT-SIDED HEMINEGLECT. THE PATIENT WAS DIAGNOSED WITH AN ISCHEMIC STROKE. THE PATIENT'S RECOVERY WAS PARTIAL WITH MINOR RESIDUALS. THERE WERE NO AIR BUBBLES NOTED AT ANY TIME DURING THE PROCEDURE. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO CORDIS PRODUCT. THE INVESTIGATOR FELT THE EVENT WAS RELATED TO THE INDEX PROCEDURE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND THE EVENT DATE WAS CHANGED TO (B)(6) 2010. THE DURATION OF THE EVENT WAS LESS THAN TWENTY-FOUR HOURS. THE EVENT WAS NOT RELATED TO CORDIS PRODUCT OR THE INDEX PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOGUARD RX EMBOLIC PROTECTION DEVICE (NTE) NTE CORDIS CORPORATION NA 70209537

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization