BEUDAMED
    FDA Adverse Event Death Summary report: N

    KRD DEVICE, EMBOLIZATION, VASCULAR

    MDR report key: 7293365 · Received February 23, 2018

    Report

    Report Number
    1820334-2018-00369
    Event Type
    Death
    Date Received
    February 23, 2018
    Date of Event
    November 1, 2017
    Report Date
    May 11, 2018
    Manufacturer
    COOK INC
    Product Code
    KRD
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION. A REVIEW OF THE INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THIS COMPLAINT WILL BE INVESTIGATED FOR A COOK TORNADO COIL. THE JOURNAL ARTICLE DOES NOT SPECIFY WHICH PART NUMBER WAS USED FOR THE PROCEDURE. HOWEVER, TORNADO COILS ARE MANUFACTURED PER THE MANUFACTURING INSTRUCTIONS WHICH DETAIL WELDING, EMBOLIZATION FIBERING, TRIM, FINISHING AND SHIPPING CANNULA ASSEMBLY INSTRUCTIONS. CLINICAL ASSESSMENT: IT IS NOT CERTAIN WHICH DEVICES MIGRATED TO THE BOWEL OR IF ANY OF THE COOK MEDICAL DEVICES MIGRATED. THERE WERE MANY FACTORS INVOLVED IN THIS CASE AND NO CONCLUSION CAN BE MADE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. WITHOUT VISUAL, DIMENSIONAL, AND/OR FUNCTIONAL TESTING OF THE PRODUCT, WE ARE UNABLE TO RULE OUT IF THIS EVENT WAS RELATED TO A MANUFACTURING ISSUE. AT THIS TIME, THE CLINICAL ASSESSMENT CANNOT ELIMINATE ANY POSSIBLE CAUSES FOR THIS EVENT SUCH AS MEDICAL PROCEDURE, USER TECHNIQUE, APPROPRIATE MEDICAL DEVICES, OTHER MANUFACTURER DEVICE, MEDICAL DEVICE COMPATIBILITY, HUMAN ANATOMY, DISEASE PROGRESSION, DEVICE FAILURE, OR MANUFACTURING RELATED CAUSES. NO PRODUCT WAS RETURNED TO CONFIRM WHICH COILS MIGRATED TO THE BOWEL RESULTING IN THE OBSTRUCTION OR IF THE COOK PRODUCT WAS INVOLVED. ADDITIONALLY, NO LOT NUMBER WAS PROVIDED TO FACILITATE INVESTIGATION OF ANY LOT RELATED ISSUES WITH THE ALLEGED DEVICE. IN ACCORDANCE WITH COOK¿S QUALITY ASSURANCE SYSTEM, PRODUCTION AND PROCESSING CONTROLS ARE IN PLACE FOR ALL PRODUCTS AND A DEVICE HISTORY RECORD IS COMPLETED FOR EACH LOT. IFU T_CE_TEM_REV_ 1 STATES: ¿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 OBSTRUCTION A NORMAL AND ESSENTIAL ARTERIAL CHANNEL. PRECAUTIONS: PERFORM AN ANGIOGRAM PRIOR TO EMBOLIZATION TO DETERMINE CORRECT CATHETER POSITION. PRIOR TO INTRODUCTION OF EMBOLIZATION COIL, FLUSH THE ANGIOGRAPHIC CATHETER WITH SALINE.¿ FOR ALL SIZES, IFU STATES "PERFORM FINAL ANGIOGRAM TO CONFIRM COIL POSITION WITHIN TARGET VESSEL." WITH NO ADDITIONAL INFORMATION BEING PROVIDED, THE COMPLAINT WILL BE LISTED AS A CONFIRMED DEATH, ROOT CAUSE UNKNOWN. WE HAVE NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    BRAND NAME: TORNADO PLATINUM EMBOLIZATION COIL. (B)(4). PMA/510K STATUS: PREAMENDMENT. W. PRESTON HEWGLEY, DAVID L. WEBB M.D., H. EDWARD GARRETT JR. M.D. (2017) MIGRATED EMBOLIZATION COIL CAUSES INTERNAL OBSTRUCTION. RETRIEVED FROM: WWW.CREATIVECOMMONS.ORG/LICENSES/BE-NC-ND/4.0/. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE FOLLOWING PATIENT EVENT IN THE ATTACHED JOURNAL ARTICLE. COILS OF VARIOUS SIZES AND MANUFACTURERS WERE INSERTED INTO THE PSEUDOANEURYSM UNTIL IT WAS COMPLETELY FILLED INCLUDING TORNADO (THIS EMDR) AND NESTER COILS (SEE RELATED EMDR#1820334-2018-00370). REPEATED IMAGING 2 WEEKS LATER SHOWED EXPANSION OF THE VISCERAL ARTERY PSEUDOANEURYSM (VAP), AND ANGIOGRAPHY REVEALED A SMALL RETROPERITONEAL ARTERY INDEPENDENTLY SUPPLYING THE ANEURYSM SAC, WHICH WAS FURTHER FILLED WITH 0.018-INCH OTHER MANUFACTURER FRAMING COILS AND HYDROCOILS. AT THIS TIME, THE PROXIMAL NORMAL GASTRODUODENAL ARTERY (GDA) WAS ALSO EMBOLIZED WITH 0.018-INCH AND 0.035-INCH DETACHABLE COILS TO PREVENT RECURRENCE. ANGIOGRAPHY AFTER COIL EMBOLIZATION OF THE GDA DEMONSTRATED NO FLOW, AND ANGIOGRAPHY OF THE SUPERIOR MESENTERIC ARTERY SHOWED NO RETROGRADE FILLING OF THE PSEUDOANEURYSM. SIX YEARS LATER, THE PATIENT PRESENTED WITH A 2-DAY HISTORY OF CONFUSION AND SEVERE ABDOMINAL PAIN WITH NAUSEA AND VOMITING. THE PATIENT HAD DIFFUSE ABDOMINAL PAIN AND DEVELOPED FEVER, TACHYCARDIA, AND HYPOTENSION SHORTLY AFTER ADMISSION. COMPUTED TOMOGRAPHY SCAN REVEALED A HIGH-GRADE DISTAL MECHANICAL SMALL BOWEL OBSTRUCTION CAUSED BY A FOREIGN BODY. THE GDA EMBOLIZATION COILS WERE ALSO DISPLACED FROM THEIR ORIGINAL LOCATION. EXPLORATION OF THE ABDOMEN REVEALED A FOREIGN BODY IN THE LUMEN OF THE BOWEL AT THE ILEOCECAL VALVE. THE SMALL BOWEL WAS DILATED BUT COMPLETELY VIABLE. ENTEROTOMY EXPOSED A METALLIC FOREIGN BODY CONSISTENT WITH A CLUSTER OF EMBOLIZATION COILS, WHICH WERE REMOVED, AND THE ENTEROTOMY WAS CLOSED PRIMARILY. UNFORTUNATELY, THE PATIENT NEVER FULLY RECOVERED FROM THE PROCEDURE, AND THEIR HOSPITAL COURSE WAS COMPLICATED BY MULTIPLE DRUG-RESISTANT INFECTIONS, PRIMARILY RELATED TO PULMONARY ASPIRATION. THE PATIENT REMAINED ENCEPHALOPATHIC AND REQUIRED MECHANICAL VENTILATION AND TUBE FEEDS UNTIL THEY EVENTUALLY EXPIRED 9 MONTHS POSTOPERATIVELY. ADDITIONAL INFORMATION WAS LATER RECEIVED FROM THE CUSTOMER. THE INITIAL PROCEDURE WAS ON (B)(6) 2010. THE PATIENT HAD MISSED A 4 WEEK FOLLOW UP POST APPOINTMENT, BUT WAS SEEN BY THEIR HEMATOLOGIST ON (B)(6) 2010. THE FINAL REMOVAL OF THE MIGRATED COILS OCCURRED ON (B)(6) 2016. THE PATIENT EXPIRED ON (B)(6) 2017. FIVE OF THE MANUFACTURER COILS WERE CONFIRMED TO HAVE BEEN USED. FOLLOWING IMPLANTATION, THE PATIENT WAS DISCHARGED ON (B)(6) 2010 AND WAS REPORTEDLY DOING WELL. IN THE 6 YEARS FOLLOWING THE IMPLANTATION PROCEDURE, THE PATIENT DID NOT RETURN TO THE OFFICE FOR ANY FOLLOW UP. PRIMARY AND SECONDARY CAUSES OF DEATH WERE REPORTED TO BE SEPSIS, CHRONIC METABOLIC ENCEPHALOPATHY, AND CHRONIC RESPIRATORY FAILURE. AUTOPSY OR DEATH REPORTS WILL NOT BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135934 KRD DEVICE, EMBOLIZATION, VASCULAR KRD COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death| H| R TERUMO FRAMING COIL, TERUMO HYDROCOILS