BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 1940661 · Received December 29, 2010

    Report

    Report Number
    1016427-2010-00157
    Event Type
    Injury
    Date Received
    December 29, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 7, 2010
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MANUFACTURER REPORT NUMBER IS 9616099-2010-01023. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE REPORT IS FROM THE (B)(4) STUDY. THE PATIENT HAD A MEDICAL HISTORY INCLUDING SEVERE PULMONARY DISEASE, CABG, SMOKING, CORONARY ARTERY DISEASE, MYOCARDIAL INFARCTION, AND HYPERTENSION. THE TARGET LESION WAS THE OSTIUM OF THE LEFT PROXIMAL INTERNAL CAROTID. PRE-PROCEDURE STENOSIS WAS 85%. LESION LENGTH WAS 12MM AND DIAMETER WAS 7MM. THE LESION WAS MILDLY CALCIFIED. THE LESION WAS PRE-DILATED. A 8 X 30MM PRECISE PRO RX STENT WAS DEPLOYED AT THE TARGET LESION. AN ANGIOGUARD RX, SIZE 5 WAS SUCCESSFULLY DEPLOYED AND RETRIEVED DURING THE PROCEDURE. DURING POST-DILATION THE PATIENT BECAME SOMEWHAT DISORIENTED AND APHASIC BUT REMAINED HEMODYNAMICALLY STABLE. REPEAT ANGIOGRAPHY DEMONSTRATED FLOW THROUGH THE FILTER BUT SUGGESTED SPASM AT THE FILTER SITE. DUE TO PATIENT MOVEMENT, THIS WAS DIFFICULT TO BE CERTAIN OF. HOWEVER, IT WAS CLEAR THAT HE HAD GOOD FLOW THROUGH THE FILTER SEGMENT AND NO EVIDENCE OF DISSECTION, THEREFORE THE FILTER WAS RETRIEVED. REPEAT IMAGING CLEARLY CONFIRMED SEVERE SPASM AT THE SITE WHERE THE FILTER HAD BEEN. 400 MCG. OF INTRA-ARTERIAL NITROGLYCERIN WAS ADMINISTERED AND THE PATIENT'S SYMPTOMS QUICKLY RESOLVED AND THE PATIENT RETURNED TO BASELINE WITHIN APPROXIMATELY THREE MINUTES. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01424011. (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/EVENT DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. VESSEL SPASM IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ANY INTERVENTIONAL PROCEDURE, WHERE DEVICES ARE INTRODUCED INTO THE VASCULATURE AND IS LISTED IN THE IFU (INSTRUCTIONS FOR USE) AS SUCH. 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.

    Additional Manufacturer Narrative · 1

    THE ALERT DATE WAS PREVIOUSLY REPORTED AS (B)(4) 2010. HOWEVER, THE CORRECT ALERT DATE IS (B)(4) 2010.

    Description of Event or Problem · 1

    THE REPORT IS FROM THE (B)(4) STUDY. THE PATIENT WAS A (B)(6) MALE WITH A HISTORY OF SEVERE PULMONARY DISEASE, CABG, SMOKING, CORONARY ARTERY DISEASE, MYOCARDIAL INFARCTION, AND HYPERTENSION. THE TARGET LESION WAS THE OSTIUM OF THE LEFT PROXIMAL INTERNAL CAROTID. PRE-PROCEDURE STENOSIS WAS 85%. LESION LENGTH WAS 12MM AND DIAMETER WAS 7MM. THE LESION WAS MILDLY CALCIFIED. THE LESION WAS PRE-DILATED. A 8 X 30MM PRECISE PRO RX STENT WAS DEPLOYED AT THE TARGET LESION. AN ANGIOGUARD RX, SIZE 5 WAS SUCCESSFULLY DEPLOYED AND RETRIEVED DURING THE PROCEDURE. DURING POST-DILATION THE PATIENT BECAME SOMEWHAT DISORIENTED AND APHASIC. HE REMAINED HEMODYNAMICALLY STABLE. REPEAT ANGIOGRAPHY DEMONSTRATED FLOW THROUGH THE FILTER BUT SUGGESTED SPASM AT THE FILTER SITE. DUE TO PATIENT MOVEMENT, THIS WAS DIFFICULT TO BE CERTAIN OF. HOWEVER, IT WAS CLEAR THAT HE HAD GOOD FLOW THROUGH THE FILTER SEGMENT AND NO EVIDENCE OF DISSECTION. WE THEREFORE RETRIEVED THE FILTER. REPEAT IMAGING CLEARLY CONFIRMED SEVERE SPASM AT THE SITE WHERE THE FILTER HAD BEEN. WE GAVE 400 MCG. OF INTRA-ARTERIAL NITROGLYCERIN. THE PATIENT'S SYMPTOMS QUICKLY RESOLVED THEREAFTER. HE GOT BACK TO HIS BASELINE WITHIN APPROXIMATELY THREE MINUTES. POST-PROCEDURE STENOSIS WAS 10%. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

    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 70710518

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention ASPIRIN, BIVALIRUDIN, CLOPIDOGREL