BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 2160459 · Received July 13, 2011

    Report

    Report Number
    2024168-2011-04953
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 17, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED EMBOSHIELD EMBOLIC PROTECTION SYSTEM (EPS) NOTED BLOOD ON THE FILTRATION ELEMENT, ON THE BARE WIRE COILS, ON THE RETRIEVAL CATHETER AND ON THE ACCUNET RECOVERY CATHETER 1 (RC1). THERE WAS NO SALINE VISIBLE. THE FILTRATION ELEMENT, BARE WIRE, RETRIEVAL CATHETER AND RC1 WERE RETURNED. THE FILTRATION ELEMENT WAS RETURNED ON THE BARE WIRE LOCATED AT THE STEP AND INSIDE THE RC1 RECOVERY CATHETER TIP. THERE WAS A KINK IN THE BARE WIRE TIP 1.3 CM PROXIMAL TO THE TIPBALL AND A KINK IN THE CORE 3.5 CM PROXIMAL TO THE STEP. THERE WAS NO OTHER DAMAGE NOTED TO THE BARE WIRE. THERE WERE TWO BENDS IN THE RETRIEVAL CATHETER SHAFT 2.5 CM AND 70 CM DISTAL TO THE HANDLE. THERE WAS A BEND IN THE RETRIEVAL CATHETER TIP 1 CM PROXIMAL TO THE DISTAL END OF THE TIP. THERE WAS NO OTHER DAMAGE NOTED TO THE RETRIEVAL CATHETER. THERE WAS NO OTHER DAMAGE NOTED TO THE EPS. THERE WAS A BEND IN THE RC1 SHAFT 53 CM DISTAL TO THE STRAIN RELIEF TUBING. THERE WAS NO OTHER DAMAGE NOTED TO THE RC1 (ACCUNET RECOVERY CATHETER 1). THE BENDS NOTED ON THE BAREWIRE AND RETRIEVAL CATHETERS ARE LIKELY DUE TO MISHANDLING DURING USE OR PACKAGING THE PRODUCT FOR RETURN TO ABBOTT VASCULAR. DURING FUNCTIONAL TESTING, AN ATTEMPT WAS MADE TO REMOVE THE FILTRATION ELEMENT FROM THE RC1 BUT IT WAS NOT ABLE TO BE REMOVED. AFTER THE FILTRATION ELEMENT AND RC1 WERE SOAKED IN THE WATER BATH, THE FILTRATION ELEMENT WAS REMOVED. THERE WAS NO DAMAGE NOTED TO THE FILTRATION ELEMENT. THE BARE WIRE TIP WAS TUGGED ON TO CONFIRM THAT THE CORE WAS STILL INTACT. DIFFICULTY RETRIEVING THE FILTRATION ELEMENT THROUGH THE STENT MAY INCLUDE, BUT IS NOT LIMITED TO, PATIENT ANATOMICAL CONDITIONS, STENT POST DILATATION STRATEGY, THE NEWLY DEPLOYED STENT NOT BEING FULLY APPOSED TO THE VESSEL WALL, LACK OF GUIDE CATHETER SUPPORT OR INTERACTION BETWEEN ASSOCIATED DEVICES. BASED ON THE REPORTED INFORMATION, IT APPEARS THAT THE DIFFICULTY ADVANCING THE RECOVERY CATHETER IS DUE TO INTERACTION WITH NEWLY PLACED STENT. AS A RESULT OF THE DIFFICULTY, AN ACCUNET WAS SUCCESSFULLY USED TO RETRIEVE THE FILTER WITHOUT FURTHER INCIDENT. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT. A QUERY OF THE COMPLAINT DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS FOR DIFFICULT TO REMOVE REPORTED FOR THIS LOT. OVERALL, THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CASE CIRCUMSTANCES AND THERE ARE NO INDICATIONS WHICH SUGGEST A PRODUCT QUALITY DEFICIENCY. AS PART OF THE MANUFACTURING QUALITY PROCESS, ALL EMBOLIC PROTECTION DEVICES AND RETRIEVAL CATHETERS ARE VISUALLY INSPECTED FOR DAMAGE. IN ADDITION, A SAMPLING OF UNITS IS VISUALLY, DIMENSIONALLY AND FUNCTIONALLY INSPECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL, THAT POST INTERVENTION OF A 30 MM LESION WITH 99% STENOSIS LOCATED IN THE LEFT INTERNAL CAROTID ARTERY WITH HEAVY CALCIFICATION, RESISTANCE WAS EXPERIENCED DURING RETRIEVAL OF THE FILTER. THE FILTER COULD NOT PASS THE IMPLANTED STENT, AN ACCULINK, EVEN WITH THE USE OF A BUDDY WIRE. AN ACCUNET WAS SUCCESSFULLY USED TO RETRIEVE THE FILTER WITHOUT FURTHER INCIDENT. A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE WAS NOT REPORTED. NO ADDITIONAL EVENT OR PATIENT INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MDR BEING FILED, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: SUBJECT INITIALS: (B)(6). ANATOMICAL EVALUATION: LEFT CAROTID INTERNAL COMMON BIFURCATION: PRE-PROCEDURE STENOSIS=99%; LESION LENGTH = 30.0 MM; HEAVY CALCIFICATION; THROMBUS ABSENT; ECHOGENICITY COMPLETELY CALCIFIED; AORTIC ARCH TYPE I DISEASE; POST PROCEDURE STENOSIS=30% THE PATIENT WAS ADMITTED ON (B)(6) 2011 AND DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011 TO HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-CT 1041151

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention STENT: ACCULINK