BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 2954069 · Received February 11, 2013

    Report

    Report Number
    1016427-2013-00016
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 18, 2013
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: IT WAS REPORTED THAT THERE WAS DIFFICULTY REMOVING THE ANGIOGUARD DURING STENTING OF A 90% STENOSIS IN THE RIGHT MID INTERNAL CAROTID ARTERY. PRE-PROCEDURE NIH STROKE SCALE WAS 0 AND THE PATIENT WAS ASYMPTOMATIC. THE LESION WAS DESCRIBED AS 20MM IN LENGTH, ARCH TYPE II, MODERATELY CALCIFIED, AND ECCENTRIC. THE REFERENCE VESSEL WAS MODERATE IN TORTUOUSITY. A 6MM ANGIOGUARD WAS DEPLOYED SUCCESSFULLY BEYOND THE TARGET LESION AND THE LESION WAS PRE-DILATED FOLLOWED BY DEPLOYMENT OF A 9.0 X 40MM PRECISE PRO RX STENT. REMOVAL DIFFICULTIES WERE EXPERIENCED WHILE REMOVING THE ANGIOGUARD FROM THE PATIENT. IT IS UNKNOWN IF THERE WAS ANY AIR BUBBLE OR DEBRIS IN THE FILTER BASKET. THERE WAS NO PATIENT INJURY REPORTED. THE POST NIH STROKE SCALE WAS 0 AND THE PATIENT WAS DISCHARGED THE NEXT DAY. THERE WERE NO DIFFICULTIES DURING DEVICE PREPPING OR FLUSHING. 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. (B)(4) DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10183688 (CORDIS LOT 70912509). (B)(4). WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT RETURN OF THE PRODUCT FOR ANALYSIS OR FILMS OF THE EVENT IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENT. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED VIA THE SAPPHIRE REGISTRY, REMOVAL DIFFICULTIES WAS EXPERIENCED WITH A 6MM ANGIOGUARD RX DURING THE INDEX PROCEDURE. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 90% STENOSIS TO THE RIGHT MID INTERNAL CAROTID ARTERY. PRE-PROCEDURE NIH STROKE SCALE WAS 0 AND THE PATIENT WAS ASYMPTOMATIC. THE LESION WAS DESCRIBED AS 20MM IN LENGTH, ARCH TYPE II, MODERATELY CALCIFIED, AND ECCENTRIC. THE REFERENCE VESSEL WAS MODERATE IN TORTUOSITY. A 6MM ANGIOGUARD WAS DEPLOYED SUCCESSFULLY BEYOND THE TARGET LESION AND THE LESION WAS PRE-DILATED. A 9.0 X 40MM PRECISE PRO RX WAS IMPLANTED AT THE TARGET LESION. REMOVAL DIFFICULTIES WERE EXPERIENCED OCCURRED DURING DEVICE REMOVAL FROM THE PATIENT. IT IS UNKNOWN IF THERE WAS ANY AIR BUBBLE OR DEBRIS IN THE FILTER BASKET. THERE WAS NO PATIENT INJURY DUE TO THE DEVICE MALFUNCTION. THE POST NIH STROKE SCALE WAS 0 AND WAS DISCHARGED THE NEXT DAY. CONCOMITANT MEDICATIONS INCLUDED CLOPIDOGREL AND ASPIRIN AT PRE AND POST PROCEDURE AND AT DISCHARGE. THERE WAS NO DIFFICULTIES DURING DEVICE PREPPING OR FLUSHING DIFFICULTIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58961 ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM EMBOLIC PROTECTION DEVICE (NTE) NTE CORDIS CORPORATION NA 70912509

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR