BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KRD DEVICE, EMBOLIZATION, VASCULAR

    MDR report key: 7321078 · Received March 7, 2018

    Report

    Report Number
    1820334-2018-00545
    Event Type
    Injury
    Date Received
    March 7, 2018
    Date of Event
    July 1, 2008
    Report Date
    June 6, 2018
    Manufacturer
    COOK INC
    Product Code
    KRD
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS PREVIOUSLY SUBMITTED, UNKNOWN, OR UNAVAILABLE. ADDITIONAL INFORMATION FROM THE AUTHOR HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED AT THE TIME OF THIS REPORT. INVESTIGATION ¿ EVALUATION. A REVIEW OF THE COMPLAINT HISTORY, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AND TRENDS OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE VISIBLE COIL MENTIONED IN THE ARTICLE IS NOT IDENTIFIED. THERE IS NO RPN OR LOT NUMBER FOR REVIEW. CLINICAL ASSESSMENT: THE ARTICLE DOES NOT STATE THE COIL MIGRATED. THERE IS NO ALLEGED MALFUNCTION OF THE DEVICE. IF THE DEVICE HAD MIGRATED OR WAS PLACED INCORRECTLY THERE IS THE POSSIBILITY OF THE DEVICE EMBOLIZING THE WRONG ARTERY RESULTING IN ¿SEVERE HARM¿ (HARM RESULTING IN LIFE-THREATENING ILLNESS OR INJURY). 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, USER TECHNIQUE, DEVICE FAILURE, OR MANUFACTURING RELATED CAUSES. 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. A COMPLAINT SEARCH COULD NOT BE CONDUCTED AS THE PRODUCT LOT IS UNKNOWN. A REVIEW OF ALL COMPLAINTS FROM 01JAN2015 TO 14MAR2018 INVOLVING MWCE-TORNADO MICROCOILS REVEALED NO SIMILAR COMPLAINTS THAT INVOLVED COILS PROTRUDING FROM THE PATIENT. DUE TO THE LACK OF SIMILAR COMPLAINTS, IT IS DETERMINED THAT THERE IS NO EVIDENCE FOR NON-CONFORMANCES IN THE FIELD. ADDITIONALLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED AS THE PRODUCT LOT IS UNKNOWN. THE TORNADO EMBOLIZATION COILS AND MICROCOILS ARE PACKAGED WITH IFU T_CE_TEM. PER T_CE_TEM, ¿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, THE ROOT CAUSE IS INCONCLUSIVE. 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. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS PREVIOUSLY SUBMITTED, UNKNOWN, OR UNAVAILABLE. ADDITIONAL INFORMATION FROM THE AUTHOR HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED AT THE TIME OF THIS REPORT. INVESTIGATION ¿ EVALUATION. A REVIEW OF THE COMPLAINT HISTORY, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AND TRENDS OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE VISIBLE COIL MENTIONED IN THE ARTICLE IS NOT IDENTIFIED. THERE IS NO RPN OR LOT NUMBER FOR REVIEW. CLINICAL ASSESSMENT: THE ARTICLE DOES NOT STATE THE COIL MIGRATED. THERE IS NO ALLEGED MALFUNCTION OF THE DEVICE. IF THE DEVICE HAD MIGRATED OR WAS PLACED INCORRECTLY THERE IS THE POSSIBILITY OF THE DEVICE EMBOLIZING THE WRONG ARTERY RESULTING IN ¿SEVERE HARM¿ (HARM RESULTING IN LIFE-THREATENING ILLNESS OR INJURY). 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, USER TECHNIQUE, DEVICE FAILURE, OR MANUFACTURING RELATED CAUSES. 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. A COMPLAINT SEARCH COULD NOT BE CONDUCTED AS THE PRODUCT LOT IS UNKNOWN. A REVIEW OF ALL COMPLAINTS FROM 01JAN2015 TO 14MAR2018 INVOLVING MWCE-TORNADO MICROCOILS REVEALED NO SIMILAR COMPLAINTS THAT INVOLVED COILS PROTRUDING FROM THE PATIENT. DUE TO THE LACK OF SIMILAR COMPLAINTS, IT IS DETERMINED THAT THERE IS NO EVIDENCE FOR NON-CONFORMANCES IN THE FIELD. ADDITIONALLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED AS THE PRODUCT LOT IS UNKNOWN. THE TORNADO EMBOLIZATION COILS AND MICROCOILS ARE PACKAGED WITH IFU T_CE_TEM. PER T_CE_TEM, ¿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, THE ROOT CAUSE IS INCONCLUSIVE. 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

    BRAND NAME: TORNADO PLATINUM EMBOLIZATION COIL. (B)(4). CITATION: FELDSTEIN R., & DEVITO B., (2008), VISIBLE COIL AFTER EMBOLIZATION FOR A BLEEDING ULCER. CLINICAL GASTROENTEROLOGY AND HEPATOLOGY. 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 ADVERSE EVENT IN A JOURNAL ARTICLE. A (B)(6) WOMAN WAS ADMITTED FOR RECTAL BLEEDING. THE PATIENT WAS AT THREE WEEKS AFTER VENTRAL HERNIA REPAIR. AFTER CONSULTATION, A DECISION WAS MADE TO PERFORM A COLONOSCOPY, WHICH REVEALED DIVERTICULOSIS THAT WAS PRESUMED TO BE THE CULPRIT AT PRESENTATION. THE SERVICE WAS RE-CONSULTED A FEW DAYS LATER FOR PERSISTENT DECREASE IN HEMOGLOBIN. NO RECTAL BLEEDING, MELENA, OR HEMATEMESIS WAS NOTED. A DECISION WAS THEN MADE TO PERFORM AN UPPER ENDOSCOPY. THE EXAM NOTED A LARGE DUODENAL ULCER THREE TO FOUR CENTIMETERS WITH OVERLYING CLOT. A TOTAL OF 23 MILLILITERS OF 1:10,000 EPINEPHRINE WAS INJECTED AROUND THE ULCER BASE SUCCEEDED IN REDUCING THE VOLUME OF ACTIVE BLEEDING. AN ATTEMPT AT CLOT REMOVAL WAS UNSUCCESSFUL. INTERVENTIONAL RADIOLOGY WAS THEN CONSULTED, AND THE PATIENT UNDERWENT EMERGENCY MESENTERIC ANGIOGRAPHY WITH COIL EMBOLIZATION OF THE CULPRIT VESSELS. A TOTAL OF 14 COILS (4 VORTEX- 18 DIAMOND SHAPE, 3.3 MILLIMETER UNRESTRAINED COIL LENGTH, 12 TORNADO COILS ¿ 5 MILLIMETER PROXIMAL DIAMETER) WERE USED TO OCCLUDE THE PROXIMAL RIGHT GASTROEPIPLOIC ARTERY TO THE PROXIMAL GASTRODUODENAL ARTERY. BLEEDING WAS SUCCESSFULLY ATTENUATED. FIVE DAYS AFTER EMBOLIZATION, ANOTHER EPISODE OF HEMATOCHEZIA WAS REPORTED. AN UPPER ENDOSCOPY WAS REPEATED, AND A CLEAN BASED BULBAR ULCER WAS IDENTIFIED, WITH A VISIBLE COIL EXTRUDING FROM THE ABLATED VESSEL. NO ACTIVE BLEEDING WAS NOTED. A DECISION WAS MADE TO REPEAT THE COLONOSCOPY; HOWEVER, BECAUSE OF EMERGING COMPLICATIONS FROM THE RECENT HERNIA REPAIR, THE PROCEDURE WAS DEFERRED. DURING THE NEXT WEEK, NO FURTHER BLEEDING EPISODES WERE NOTED; THE HEMOGLOBIN LEVEL REMAINED STABLE, AND THE FOLLOW-UP AS AN OUTPATIENT WAS RECOMMENDED. THE COMPLAINT PRODUCT IS UNAVAILABLE FOR RETURN AND EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164054 KRD DEVICE, EMBOLIZATION, VASCULAR KRD COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention VORTX-18 DIAMOND, BOSTON SCIENTIFIC-3.3MM COIL| VORTX-18 DIAMOND, BOSTON SCIENTIFIC-3.3MM COIL