BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 2182167 · Received July 28, 2011

    Report

    Report Number
    2024168-2011-05340
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 6, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 ADDITIONAL RELEVANT INFORMATION. THE PROGLIDE DEVICE IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION NOTED THAT ONLY THE RETRIEVAL CATHETER, BAREWIRE WITH THE FILER BASKET, AND A NON-ABBOTT INTRODUCER SHEATH WERE RETURNED. THERE WAS BLOOD ON THE FULL LENGTH OF THE RETRIEVAL CATHETER, COILS, BAREWIRE, AND INTRODUCER SHEATH, CONSISTENT WITH BEING ADVANCED INTO THE ANATOMY. THERE WAS NO SALINE VISIBLE. THE FILTRATION ELEMENT WAS RETURNED FULLY LOADED INTO THE RETRIEVAL CATHETER. THE RETRIEVAL CATHETER WAS KINKED AT THE PROXIMAL AND DISTAL ENDS OF THE GUIDE WIRE EXIT NOTCH AND 2 CM DISTAL TO THE HANDLE. THE RETRIEVAL CATHETER WAS BENT 2 CM PROXIMAL TO THE GUIDE WIRE EXIT NOTCH. THERE WAS NO OTHER DAMAGE NOTED TO THE RETRIEVAL CATHETER. THERE WAS A BEND IN THE CORE 4 CM PROXIMAL TO THE TIP BALL. THERE WAS NO OTHER DAMAGE NOTED TO THE BAREWIRE. THE TIP OF THE BAREWIRE WAS TUGGED TO VERIFY THAT THE CORE WAS INTACT. DIFFICULTY REMOVING THE RETRIEVAL CATHETER MAY INCLUDE, BUT IS NOT LIMITED TO, PATIENT ANATOMICAL CONDITIONS, STENT POST DILATATION STRATEGY, A NEWLY DEPLOYED STENT NOT BEING FULLY APPOSED TO THE VESSEL WALL, LACK OF GUIDE CATHETER SUPPORT OR INTERACTION BETWEEN ASSOCIATED DEVICES. IN THIS CASE, BASED ON THE REPORTED INFORMATION, IT MAY BE POSSIBLE THAT INTERACTION WITH THE FILTRATION ELEMENT AND DISTAL END OF THE RETRIEVAL CATHETER DURING COLLAPSING OF THE FILTER CONTRIBUTED TO THE DAMAGE TO THE RETRIEVAL CATHETER. IF THE FILTRATION ELEMENT DOES NOT COLLAPSE PROPERLY INTO THE RETRIEVAL CATHETER DUE TO ANATOMICAL CONDITIONS OR LACK OF GUIDE CATHETER SUPPORT, THE TIP OF THE RETRIEVAL CATHETER MAY BECOME DAMAGED OR ACCORDIONED AS REPORTED. THIS DIFFICULTY MAY ALSO CAUSE THE SHAFT OF THE RETRIEVAL CATHETER TO KINK IF FORCE APPLIED TO COLLAPSE THE FILTER. THE ADDITIONAL KINKS MAY ALSO BE THE RESULT OF HANDLING/PACKING THE DEVICE FOR RETURN TO ABBOTT VASCULAR FOR ANALYSIS. ULTIMATELY, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FOR THE REPORTED DIFFICULTIES; HOWEVER, THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY. AS IT WAS REPORTED THAT THE EMBOSHIELD NAV 6 WAS USED IN THE FEMORAL ARTERY, IT SHOULD BE NOTED THAT THE NAV6 INDICATION FOR USE AS LISTED IN THE INSTRUCTION FOR USE STATES: THE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM IS INDICATED FOR USE AS A GUIDE WIRE AND EMBOLIC PROTECTION SYSTEM TO CONTAIN AND REMOVE EMBOLIC MATERIAL (THROMBUS / DEBRIS) WHILE PERFORMING ANGIOPLASTY AND STENTING PROCEDURES IN CAROTID ARTERIES. IN THIS CASE, IT COULD NOT BE DETERMINED IF THE OFF-LABEL USE CONTRIBUTED TO THE DIFFICULTIES, AN IN-SERVICE LETTER WILL NOT BE REQUESTED. A REVIEW OF THE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT. ADDITIONALLY, THERE HAVE BEEN NO OTHER INCIDENTS FOR ENTANGLEMENT REPORTED FOR THIS LOT AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. AS PART OF MANUFACTURING QUALITY PROCESS, ALL EMBOLIC PROTECTION DEVICES 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 THAT AFTER A DIAGNOSTIC LEFT HEART CATHETERIZATION THROUGH A 6F PROCEDURAL SHEATH, ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ACHIEVED USING A PERCLOSE PROGLIDE DEVICE. REPORTEDLY, TWO DAYS LATER, THE PATIENT RETURNED TO THE HOSPITAL COMPLAINING OF INCREASING SORENESS AND PAIN AT THE ARTERIOTOMY SITE. THE PATIENT WAS READMITTED FOR EMERGENT EXPLORATORY ANGIOGRAPHY, WHICH REVEALED AN OCCLUSION FROM AN UNKNOWN MATERIAL AT THE ACCESS SITE. BECAUSE THE OCCLUDING MATERIAL COULD NOT BE IDENTIFIED, AN EMBOLIC PROTECTION DEVICE, EMBOSHIELD NAV6, WAS PLACED PROXIMAL TO THE OCCLUDED AREA IN THE VESSEL; HOWEVER, SUTURE FROM THE PROGLIDE DEVICE WAS FOUND DEPLOYED THROUGH THE BACK WALL OF THE COMMON FEMORAL ARTERY THAT CAUSED THE OCCLUSION. AFTER SUCCESSFUL REVASCULARIZATION WITH A BALLOON DILATATION CATHETER, AN ATTEMPT WAS MADE TO REMOVE THE EMBOSHIELD NAV6 FILTER ELEMENT. HOWEVER, AFTER FULLY ENCLOSING THE FILTER ELEMENT WITHIN THE RETRIEVAL CATHETER, THE DEVICE WAS BEING REMOVED OVER THE BAREWIRE BUT THE RETRIEVAL CATHETER ACCORDIONED, AND COULD NOT BE REMOVED THROUGH THE GUIDE CATHETER. THE FILTER ELEMENT, BAREWIRE, AND GUIDE CATHETER WERE REMOVED AS ONE UNIT. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN STATED THAT HE DID NOT FORCEFULLY PULL THE RETRIEVAL CATHETER INTO THE GUIDE CATHETER AND HE DID NOT ENCOUNTER ANY RESISTANCE DURING ADVANCEMENT OR WITHDRAW OF THE RETRIEVAL CATHETER. THE PHYSICIAN IS TRAINED IN BOTH THE EMBOSHIELD NAV6 AND PROGLIDE DEVICES. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-CT 1051261

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention PROCEDURAL SHEATH 6F