BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NESTER PLATINUM EMBOLIZATION MICROCOIL

    MDR report key: 7396209 · Received April 4, 2018

    Report

    Report Number
    1820334-2018-00829
    Event Type
    Malfunction
    Date Received
    April 4, 2018
    Date of Event
    September 12, 2014
    Report Date
    May 16, 2018
    Manufacturer
    COOK INC
    Product Code
    KRD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. CLINICAL ASSESSMENT:THE COIL MIGRATED DUE TO REGURGITATION. THERE IS NO INFORMATION REGARDING THE REASON FOR REGURGITATION IN THE ARTICLE. WHEN A COIL MIGRATES, THERE IS A POTENTIAL THE COIL COULD BLOCK OR PARTIALLY BLOCK ARTERIAL FLOW RESULTING IN ¿SERIOUS HARM.¿ THERE ARE OTHER DEVICES INVOLVED IN THIS PROCEDURE. THERE IS NO INFORMATION REGARDING COMPLICATIONS INVOLVED WITH PLACING COIL THAT MAY HAVE CONTRIBUTED TO THE REGURGITATION AND MIGRATION. THERE IS NO INFORMATION REGARDING WHETHER THE OTHER DEVICES MET THEIR MANUFACTURER¿S QUALITY SPECIFICATIONS. THERE IS A KNOWN INHERENT RISK THAT COILS COULD BECOME DISLODGED AND OBSTRUCT A NORMAL AND ESSENTIAL ARTERIAL CHANNEL. AT THIS TIME, THE CLINICAL ASSESSMENT CANNOT ELIMINATE ANY POSSIBLE CAUSES FOR THIS EVENT SUCH AS PRODUCT HANDLING, MEDICAL PROCEDURE, OTHER DEVICE COMPATIBILITY, HUMAN ANATOMY, DEVICE FAILURE, OR MANUFACTURING RELATED CAUSES. THE 'PUSHABLE' COIL GROUP BEING THE COOK MEDICAL NESTER MICROCOILS REFERRED TO IN THE COMPLAINT. THIS COMPLAINT COVERS THE COILS USED IN ONE OF THE PATIENTS THAT DID NOT RESULT IN HEPATIC ARTERY DISSECTION BUT DID RESULT IN REGURGITATION. FROM THE ARTICLE IT WILL BE ASSUMED THAT 2 COILS WERE USED. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT LOT SEARCH COULD NOT BE CONDUCTED. IT IS DETERMINED THAT THERE IS NO EVIDENCE FOR NON-CONFORMANCES IN THE FIELD AS THERE ARE ONLY 6 SIMILAR COMPLAINTS THAT INVOLVED MIGRATION OF THE MICROCOIL AND NONE HAD RELATED PRODUCT LOTS. IT HAS BEEN DETERMINED THIS FAILURE IS AN INHERENT RISK OF THE DEVICE. THE DEVICE IS SHIPPED WITH AN IFU WHICH NOTES: WARNINGS (¿) POSITIONING OF EMBOLIZATION COILS SHOULD BE DONE WITH PARTICULAR CARE. COILS SHOULD NOT BE LEFT TOO CLOSE TO THE INLETS OF ARTERIES AND SHOULD BE INTERMESHED WITH PREVIOUSLY PLACED COILS IF POSSIBLE. A MINIMAL BUT SUFFICIENT ARTERIAL BLOOD FLOW SHOULD REMAIN TO HOLD THE COILS AGAINST THE PREVIOUSLY PLACED COILS UNTIL A SOLID CLOT ENSURES PERMANENT FIXATION. THE PURPOSE OF THESE SUGGESTIONS IS TO MINIMIZE THE POSSIBILITY OF LOOSE COILS BECOMING DISLODGED AND OBSTRUCTING A NORMAL AND ESSENTIAL ARTERIAL CHANNEL. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 1

    PATIENT AGE: THE STUDY INCLUDED 50 PATIENTS AGE 31-81. THE AGE OF THE PATIENT ASSOCIATED WITH THIS REPORT REMAINS UNKNOWN AT THIS TIME. PATIENT SEX: THE STUDY INCLUDED 42 MALES AND 8 FEMALES. THE SEX OF THE PATIENT ASSOCIATED WITH THIS REPORT REMAINS UNKNOWN AT THIS TIME. THE 510K STATUS: PREAMENDMENT. CONCOMITANT DEVICES: VORTEX COILS&INTERLOCK IDC COIL-BOSTON SCIENTIFIC, TERUMO-RADIOFOCUS. (B)(4). PARK, S. ET. AL, (2015), PROSPECTIVE RANDOMIZED TRIAL COMPARING PUSHABLE COIL AND DETACHABLE COIL DURING PERCUTANEOUS IMPLANTATION OF PORT-CATHETER SYSTEM FOR HEPATIC ARTERY INFUSION CHEMOTHERAPY, ABDOMINAL IMAGING. RECVD 31JAN2018. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE ATTACHED JOURNAL ARTICLE, DURING THE PROCEDURES, 5 COILS IN 3 PATIENTS OF THE PUSHABLE COIL GROUP WERE REMOVED USING MICRO-SNARE DUE TO REGURGITATION INTO THE HEPATIC ARTERY AFTER DEPLOYMENT. THIS REPORT ADDRESSES PATIENT 2/3. COIL EMBOLIZATION WAS SUCCESSFUL IN 49/ 50 PATIENTS. THE DEVICE IS INDICATED AS NOT AVAILABLE FOR RETURN. THERE IS NOT ANY REPORTED ADVERSE EVENTS FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239528 NESTER PLATINUM EMBOLIZATION MICROCOIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1