BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 2231913 · Received September 1, 2011

    Report

    Report Number
    2024168-2011-06098
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE SELF EXPANDING STENT SYSTEM (SESS) WAS RETURNED WITH BLOOD IN THE DISTAL OUTER SHEATH AND OUTER MEMBER AND ON THE HANDLE, CONSISTENT WITH BEING ADVANCED INTO THE ANATOMY. THERE WAS NO SALINE VISIBLE. THE STENT IMPLANT WAS NOT RETURNED, SUGGESTING THAT IT HAD BEEN DEPLOYED. THE DISTAL OUTER SHEATH WAS NOT RETRACTED. THE HANDLE WAS IN AN UNLOCKED POSITION. THE SHAFT WAS SEPARATED AT TWO SECTIONS 35.5 CM AND 57.5 CM DISTAL TO THE STRAIN RELIEF TUBING, BUT BOTH WERE STILL ATTACHED BY A SMALL PORTION OF OUTER MEMBER MATERIAL. THERE WERE MULTIPLE KINKS THROUGH OUT THE ENTIRE LENGTH OF THE SHAFT. THERE WAS NO OTHER DAMAGE NOTED TO THE SESS. THE GUIDE WIRE USED DURING THE PROCEDURE WAS NOT RETURNED. BOTH SECTIONS OF THE SHAFT FULLY SEPARATED DURING ANALYSIS. THERE WAS NO REPORTED INFORMATION ON THE DEVICE. THE ORIGINAL COMPLAINT OF DIFFICULT TO INSERT THE ACCUNET GUIDE WIRE WAS REPORTED ON INCIDENT PART SEQUENCE 186958-1-3 (1011340-30 / 0092261). THE DEVICE RETURNED IN THIS CASE WAS (1011340-30 / 0092261). THE ACCOUNT WAS CONTACTED TO OBTAIN INFORMATION REGARDING THE CONDITION OF THE RETURNED UNIT. THE RESPONSE STATED THAT HE WAS GIVEN THE DEVICE BY CATH LAB STAFF AFTER IT WAS REPORTED AS NOT BEING USED AND HAS NO FURTHER INFORMATION AVAILABLE AND DOES NOT KNOW WHERE THE MISSING STENT IS. ADDITIONAL INFORMATION RECEIVED STATES THAT THE ACCULINK STENT SYSTEM WAS DISCARDED INTO THE GARBAGE AFTER THE ACCUNET GUIDE WIRE COULD NOT BE INSERTED INTO THE DEVICE AND WAS THEN RETRIEVED FROM THE GARBAGE TO SEND BACK TO ABBOTT VASCULAR. HE IS UNSURE IF THE STENT WAS STILL ON THE SYSTEM WHEN IT WAS RETRIEVED FROM THE GARBAGE. BASED ON THIS ADDITIONAL INFORMATION AND THE CONDITION OF THE RETURNED DEVICE, IT IS LIKELY THAT THE UNIT RETURNED WHICH WAS RETRIEVED FROM THE TRASH WAS ACTUALLY THE SECOND RX ACCULINK THAT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ASSOCIATED NONCONFORMING MATERIAL RECORDS, INDICATING ALL LOT RELEASE TESTING MET SPECIFICATION. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO SIMILAR INCIDENTS REPORTED. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. DURING MANUFACTURING ALL SELF EXPANDING STENT SYSTEMS ARE 100% VISUALLY INSPECTED AT MULTIPLE LOCATIONS. IN ADDITION, A SAMPLING OF UNITS IS VISUALLY, DIMENSIONALLY AND FUNCTIONALLY INSPECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE ACCUNET GUIDE WIRE COULD NOT BE INSERTED INTO THE ACCULINK STENT SYSTEM. THE ACCULINK STENT SYSTEM WAS NOT USED AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. A NEW ACCULINK II STENT SYSTEM WAS USED TO COMPLETE THE PROCEDURE. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS REVEALED THAT THE STENT SYSTEM THAT WAS RETURNED WAS A DIFFERENT STENT SYSTEM THAN WAS REPORTED. THE REPORTED STENT SYSTEM WAS NOT RETURNED. ADDITIONALLY, THE STENT IMPLANT FOR THE RETURNED DEVICE WAS NOT RETURNED, THE HANDLE WAS IN THE UNLOCKED POSITION AND THE SHAFT WAS SEPARATED IN TWO PLACES BUT BOTH WERE ATTACHED BY A SMALL PORTION OF THE OUTER MEMBER MATERIAL. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE CATH LAB STAFF REPORTED THE DEVICE AS NOT BEING USED AND CANNOT EXPLAIN WHY A DIFFERENT DEVICE WAS RETURNED. ALTHOUGH THE DEVICE WAS RETURNED WITHOUT THE STENT, CATH LAB STAFF ARE 100% SURE THAT THE STENT IS NOT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 1071361

    Patients

    Seq Age Sex Outcome Treatment
    1 EMBOLIC PROTECTION: ACCUNET