BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 9316762 · Received November 13, 2019

    Report

    Report Number
    1820334-2019-02874
    Event Type
    Malfunction
    Date Received
    November 13, 2019
    Date of Event
    June 4, 2019
    Report Date
    April 9, 2020
    Manufacturer
    COOK INC
    Product Code
    KRD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION: COOK OPENED THIS COMPLAINT BASED ON INFORMATION FROM A LITERATURE ARTICLE: SHIM, J., ET AL. ¿CLINICAL OUTCOME OF THE VISIBLE COIL DURING ENDOSCOPY AFTER TRANSCATHETER ARTERIAL EMBOLIZATION FOR GASTROINTESTINAL BLEEDING,¿ CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY. THE ARTICLE REPORTED SUBMUCOSAL MIGRATION OF COOK EMBOLIZATION COILS PLACED BETWEEN 2001 AND 2017. THIS COMPLAINT ADDRESSES PATIENT 10, A 74 YEAR-OLD FEMALE WHO PRESENTED WITH HEMATOCHEZIA AND WAS FOUND TO HAVE A GASTRODUODENAL ARTERIAL BLEED FROM A DUODENAL ULCER. THE PATIENT UNDERWENT TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) USING TWO UNKNOWN COOK MICRONESTER OR TORNADO EMBOLIZATION COILS AND N-BUTYL CYANOACRYLATE(NBCA). A SUBMUCOSAL MIGRATION WAS SEEN ON ENDOSCOPIC EXAMINATION AFTER TAE. NO FURTHER BLEEDING WAS SEEN ON ENDOSCOPIC EXAMINATION. SECOND -LOOK ENDOSCOPY SHOWED HEALING ULCERATION. FINAL-LOOK ENDOSCOPY SHOWED SCAR FORMATION. THERE WERE NO REPORTED ADVERSE EFFECTS ON THE PATIENT. A REVIEW OF THE COMPLAINT HISTORY, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL OF THE DEVICE, AS WELL AS VISUAL INSPECTION OF IMAGING FROM THE LITERATURE ARTICLE, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, THE AUTHOR INCLUDED FLUOROSCOPIC AND ENDOSCOPIC IMAGES OF THE FAILURE IN FIGURE 1 FOR PATIENT 10. THE IMAGES SHOW EMBOLIZATION COILS AND NBCA PLACED IN A PSEUDOANEURYSM IN THE GASTRODUODENAL ARTERY. AN ENDOSCOPIC IMAGE TAKEN 1 DAY POST-PLACEMENT SHOWS AN EMBOLIZATION COIL MIGRATED INTO THE DUODENAL MUCOUS MEMBRANE. ENDOSCOPY PERFORMED 5 DAYS AFTER TAE SHOWS THE COIL IS SLIGHTLY VISIBLE AND COVERED BY EPITHELIUM OF THE MUCOUS MEMBRANE. ENDOSCOPY PERFORMED 179 DAYS AFTER TAE SHOWS THAT THE EPITHELIAL REGENERATION HAD SCAR CHANGE AND A BARELY VISIBLE COIL. THERE IS NO EVIDENCE THAT THE DEVICES WERE MANUFACTURED OUT OF SPECIFICATION. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. APPROPRIATE INSPECTIONS ARE IN PLACE RELATED TO THIS FAILURE. THE CUSTOMER DID NOT PROVIDE A LOT NUMBER FOR THE COMPLAINT DEVICE. BECAUSE THE IMPLANT TIME PERIOD IS FROM 2001 TO 2017, AND THE EXACT IMPLANT FACILITY IS UNKNOWN, COOK IS UNABLE TO IDENTIFY THE COMPLAINT LOT. THEREFORE, COOK IS UNABLE TO REVIEW THE DEVICE HISTORY RECORD FOR THIS COMPLAINT. BOTH NESTER AND TORNADO COILS ARE SHIPPED WITH INSTRUCTION FOR USE (IFU) WHICH PROVIDE THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: "WARNINGS POSITIONING OF EMBOLIZATION COILS AND MICROCOILS 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. COIL DELIVERY TECHNIQUE AND COIL SIZE SELECTION LONG-TERM OCCLUSION DEPENDS ON ACHIEVING CROSS-SECTIONAL OCCLUSION OF THE BLOOD VESSEL, AND COAXIAL CATHETERS PROVIDE THE ABILITY TO CONTROL PLACEMENT OF COILS AND PERMANENT OCCLUSION. THE COMBINATION OF THE COAXIAL TECHNIQUE AND EITHER THE ANCHOR OR SCAFFOLD TECHNIQUE SIGNIFICANTLY ENHANCES STABILITY OF COIL DEPLOYMENT. IN GENERAL, THE FIRST COIL SELECTED SHOULD HAVE A DIAMETER THAT IS 20% LARGER, OR A T LEAST 2MM OVERSIZED, THAN THE VESSEL THAT IS BEING OCCLUDED." THE IFUS ALSO INSTRUCT TO PERFORM A FINAL ANGIOGRAM TO CONFIRM COIL POSITION WITHIN TARGET VESSEL. THERE IS NO EVIDENCE OF NONCONFORMING MATERIAL IN HOUSE OR IN THE FIELD. THE COIL SIZE AND VESSEL SIZE ARE UNKNOWN. IT IS POSSIBLE THAT THE COIL WAS IMPROPERLY SIZED, LEADING TO SUBMUCOSAL MIGRATION, BUT THIS CANNOT BE CONFIRMED. BASED ON THE LIMITED INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF THE INVESTIGATION, IT WAS CONCLUDED THAT THE CAUSE OF THIS EVENT IS COMPONENT FAILURE WITHOUT IDENTIFIED DESIGN OR MANUFACTURING DEFICIENCY. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. CONCOMITANT PRODUCTS: 5F CATHETERS (ROSCH; COOK, INC, BLOOMINGTON, IN, USA); 2.-2.4-F MICROCATHETER (PROGREAT, TERUMO INC.; RENEGADE, BOSTON SCIENTIFIC, MARLBOROUGH, MA, USA); AND N-BUTYL CYANOACRYLATE (NBCA) (HISTOACRYL; B.BRAUN, MELSUNGEN, GERMANY) PMA/510(K) #: UNKNOWN. 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 BELOW DESCRIPTION OF A MICRONESTER OR TORNADO PLATINUM EMBOLIZATION MICROCOIL MIGRATION WAS TAKEN FROM THE FOLLOWING LITERATURE ARTICLE: JONG-JOON SHIM, HEE HO CHU, JI HOON SHIN, ET AL. "CLINICAL OUTCOME OF THE VISIBLE COIL DURING ENDOSCOPY AFTER TRANSCATHETER ARTERIAL EMBOLIZATION FOR GASTROINTESTINAL BLEEDING." CARDIOVASC INTERVENT RADIOL (2019) 42:1537¿1544. THE FOLLOWING IS STATED IN THE ARTICLE: "CELIAC AND SUPERIOR MESENTERIC ARTERIOGRAPHY WAS ROUTINELY PERFORMED USING 5-F CATHETERS (ROSCH; COOK, INC, BLOOMINGTON, IN, USA). IF BLEEDING SIGNS WERE NOT DEFINITIVE, FURTHER SELECTIVE ANGIOGRAPHY OF THE LEFT GASTRIC, RIGHT GASTRIC, SHORT GASTRIC, POSTERIOR GASTRIC, GASTRODUODENAL OR PANCREATICODUODENAL ARTERIES WITH FORCEFUL CONTRAST MEDIUM INJECTION WAS PERFORMED IN ORDER TO RULE OUT A FALSE NEGATIVE RESULT. SUPER SELECTIVE CANNULATION IN BLEEDING ARTERIES WAS PERFORMED USING A 2.0¿2.4-F MICROCATHETER [FROM ANOTHER MANUFACTURER]. AFTER THE SELECTIVE CATHETERIZATION OF A BLEEDING ARTERY, EMBOLIZATION WAS PERFORMED UNDER FLUOROSCOPIC MONITORING USING MICROCOILS (MICRONESTER OR TORNADO; COOK, INC., BLOOMINGTON, IN, USA). ADDITIONAL USE OF DIFFERENT TYPES OF EMBOLIC MATERIAL WAS CONSIDERED DEPENDING ON THE MANIFESTATION OF BLEEDING SIGNS OR THE OPERATOR¿S PREFERENCE. COMPLETE ANGIOGRAMS WERE PERFORMED IN ORDER TO CONFIRM THAT THE BLEEDING HAD BEEN SUCCESSFULLY CONTROLLED. AFTER THE TAE, FOLLOW-UP ENDOSCOPIC EXAMINATION WAS PERFORMED AFTER 1¿5 DAYS IN ORDER TO EVALUATE ITS EFFICACY AS WELL AS THE POSSIBILITY OF PROCEDURE-RELATED COMPLICATIONS. IF ON ENDOSCOPIC EXAMINATION A PATIENT SHOWED RECURRENT BLEEDING FROM A PREVIOUSLY TREATED LESION, THEY UNDERWENT ADDITIONAL SCLEROTHERAPY. AFTER THE CONFIRMATION OF COMPLETE HEMOSTASIS WITHOUT REBLEEDING ON ENDOSCOPIC EXAMINATION, REGULAR FOLLOW-UP WAS SCHEDULED IN THE OUTPATIENT CLINIC 1¿3 MONTHS LATER BY EACH PATIENT¿S CIRCUMSTANCES." PATIENT #10, A 74 YEAR OLD FEMALE PRESENTED WITH MASSIVE HEMATOCHEZIA, A LARGE PSEUDOANEURYSM FROM A BRANCH OF THE GASTRODUODENAL ARTERY, AND A GASTRODUODENAL ARTERY BLEED DUE TO A DUODENAL ULCER. THE PATIENT WAS TREATED WITH 2 COILS AND N-BUTYL CYANOACRYLATE(NBCA) DURING TRANSCATHETER ARTERIAL EMBOLIZATION (TAE). TECHNICAL SUCCESS WAS ACHIEVED, WITH COMPLETE OCCLUSION OF THE BLEEDING ARTERY SEEN ON POST-EMBOLIZATION ANGIOGRAPHY. CLINICAL SUCCESS WAS ACHIEVED WITH NO FURTHER BLEEDING SEEN ON ENDOSCOPIC EXAMINATION.A DAY AFTER TAE WAS PERFORMED, ENDOSCOPIC EXAMINATION SHOWED THE PRESENCE OF DUODENAL ULCERS AND A SUBMUCOSAL MIGRATION WITH A METAL COIL IN THE DUODENAL MUCOUS MEMBRANE. AFTER THE DETECTION OF THE EXTRAVASCULAR COIL ON ENDOSCOPIC EXAMINATION, FOLLOW-UP SECOND-LOOK ENDOSCOPIC EVALUATION WAS PERFORMED 5 DAYS LATER AND SHOWED A SLIGHTLY VISIBLE COIL COVERED BY EPITHELIUM OF THE MUCOUS MEMBRANE AND HEALING ULCERATION. REGULAR ENDOSCOPIC EXAMINATION WAS PERFORMED 179 DAYS LATER AND THE FINAL-LOOK ENDOSCOPY SHOWED SCAR FORMATION, EPITHELIAL REGENERATION, AND A BARELY VISIBLE COIL. THERE WERE NO MAJOR COMPLICATIONS ASSOCIATED WITH TAE OR EXTRAVASCULAR COIL DURING THE FOLLOW-UP PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1109872 UNKNOWN KRD DEVICE, EMBOLIZATION, VASCULAR KRD COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR SEE H10.