BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCUNET EMBOLIC PROTECTION SYSTEM

    MDR report key: 8528593 · Received April 18, 2019

    Report

    Report Number
    2024168-2019-03071
    Event Type
    Injury
    Date Received
    April 18, 2019
    Date of Event
    March 26, 2019
    Report Date
    May 9, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K081549
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL FILE NUMBER - (B)(4). EVALUATION SUMMARY: VISUAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED SEPARATION WAS CONFIRMED. THE DIFFICULTY REMOVING (RECOVERING THE FILTER) COULD NOT BE TESTED AS THE FILTER WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT REVEALED NO OTHER SIMILAR INCIDENTS. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE CAUSE FOR THE REPORTED DIFFICULTIES. IT MAY BE POSSIBLE THAT THE FILTER WAS OVER-LOADED WITH EMBOLI SUCH THAT THE FILTER WAS UNABLE TO COLLAPSE INTO THE RECOVERY CATHETER, AND WHEN FORCE WAS APPLIED, THE FILTER DETACHED FROM THE WIRE. HOWEVER, THIS COULD NOT BE CONFIRMED. THE ADDITIONAL TREATMENT TO APPOSE THE DETACHED FILTER AGAINST THE VESSEL WALL WAS RELATED TO CASE CIRCUMSTANCES. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE INTERNAL AND COMMON CAROTID ARTERY. A RX ACCUNET EMBOLIC PROTECTION SYSTEM (EPS) WAS ADVANCED. A 7-10X40MM .014 ACCULINK II RX STENT WAS ADVANCED TO THE TARGET LESION AND THE STENT WAS DEPLOYED WITHOUT ISSUES. AN ATTEMPT WAS MADE TO RETRIEVE THE EPS FILTER WITH ONE OF THE RETRIEVAL CATHETER PROVIDED PER THE INSTRUCTIONS FOR USE; HOWEVER, THE FILTER WOULD NOT FULLY ENGAGE WITH THE RETRIEVAL CATHETER. IT WAS THEN DECIDED TO ATTEMPT TO USE THE SECOND RETRIEVAL CATHETER PROVIDED IN THE 3-IN-1 RX ACCUNET EPS. AN ATTEMPT TO REMOVE THE FIRST RETRIEVAL CATHETER WAS MADE; HOWEVER, SINCE THE FILTER WAS PARTIALLY ENGAGED WITH THE RETRIEVAL CATHETER THE FILTER SEPARATED FROM THE WIRE AND LANDED AT THE PROXIMAL END OF THE DEPLOYED ACCULINK STENT. BALLOON ANGIOPLASTY WAS PERFORMED A COUPLE OF TIMES TO FACILITATE FILTER MOVEMENT AND A 7X20MM .014 ACCULINK II RX STENT WAS DEPLOYED TO APPOSE THE FILTER AGAINST THE VESSEL WALL. THE PATIENT IS FINE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321576 RX ACCUNET EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-CT 9020761

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention STENT: .014 ACCULINK II 7-10X40MM