BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 9488298 · Received December 18, 2019

    Report

    Report Number
    3001845648-2019-00737
    Event Type
    Injury
    Date Received
    December 18, 2019
    Date of Event
    August 5, 2016
    Report Date
    December 8, 2019
    Manufacturer
    COOK IRELAND LTD
    Product Code
    ESW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXACT RPN FOR THIS DEVICE IS UNKNOWN HOWEVER THE MOST LIKELY 510 K # IS THE FOLLOWING: K093619. DEVICE EVALUATION: THE EVO (ESOPHAGEAL METAL) DEVICE OF UNKNOWN LOT NUMBER WAS NOT RETURNED TO COOK IRELAND FOR EVALUATION. WITH THE INFORMATION PROVIDED, DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE, WHERE FULLY COVERED ESOPHAGEAL SEMS USED INCLUDED THE ENDOMAXX STENT (MERIT MEDICAL, SOUTH JORDAN UT), THE WALLFLE STENT (BOSTON SCIENTIFITTM ENDOSCOPY, NATICK, MA), THE BONASTEN (ENDOCHOICE, ATLANTA, GA), OR THE EVOLUTION STENT (COOK ENDOSCOPY, WINSTON-SALEM, NC). SIX EVOLUTION STENTS WERE NOTED IN TOTAL OF 93 STENTS, NOTED IN "TABLE 1. PATIENT AND STENT CHARACTERISTICS". THIS FILE CAPTURES STENT OBSTRUCTION (FOOD IMPACTION). NOTE: 1 EVOLUTION STENT WAS INVOLVED IN THE SUTURE GROUP. DOCUMENTS REVIEW INCLUDING IFU REVIEW: AS THE EVO (ESOPHAGEAL METAL) DEVICE FROM UNKNOWN LOT NUMBER, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. PRIOR TO DISTRIBUTION ALL EVO(ESOPHAGEAL METAL) DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. AS PER THE INSTRUCTIONS FOR USE, IFU0061-5, WHICH INFORMS THE USER ABOUT THE POTENTIAL COMPLICATIONS "ADDITIONAL COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO : PERFORATION, HEMORRHAGE, ASPIRATION, REFLUX, FEVER, INFECTION, ALLERGIC REACTION TO MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST. ADDITIONAL COMPLICATION INCLUDE, BUT ARE NOT LIMITED TO: STENT MISPLACEMENT AND/OR MIGRATION; TUMOR INGROWTH OR OVERGROWTH; ESOPHAGEAL ULCERATION AND EROSION; NAUSEA; CHEST OR RETROSTERNAL PAIN; FOREIGN BODY SENSATION; FOOD BOLUS IMPACTION; GASBLOAT; SENSITIVITY TO METAL COMPONENTS; FISTULA INVOLVING TRACHEA, BRONCHI OR PLEURAL SPACE; INTESTINAL OBSTRUCTION SECONDARY TO MIGRATION; MEDIASTINITIS OR PERITONITIS; AIRWAY COMPRESSION; TRACHEAL OBSTRUCTION. ON REVIEW OF THE INFORMATION PROVIDED, THERE IS NO EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. INFORMATION RECEIVED IS NOT SUFFICIENT ENOUGH TO CONFIRM THAT IT WAS THE COOK STENT THAT CONTRIBUTED TO THE EVENT. THEREFORE RISK WILL NOT BE COMPLETE DUE TO THE LIMITATION OF AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT CONDITION RELATED, AS PER INSTRUCTIONS FOR USE, FOOD BOLUS IMPACTION IS LISTED AS A COMPLICATION FOLLOWING THE PLACEMENT OF THIS DEVICE. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. PATIENT OUTCOME IS UNKNOWN. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    TITLE OF LITERATURE REVIEW: ''ESOPHAGEAL STENT FIXATION WITH ENDOSCOPIC SUTURING DEVICE IMPROVES CLINICAL OUTCOMES AND REDUCES COMPLICATIONS IN PATIENTS WITH LOCALLY ADVANCED ESOPHAGEAL CANCER PRIOR TO NEOADJUVANT THERAPY: A LARGE MULTICENTER EXPERIENCE'' YANG ET AL 2016. AS INITIALLY REPORTED TO CUSTOMER RELATIONS VIA LITERATURE ARTICLE: LATE AES OCCURRED IN 2 PATIENTS AND INCLUDED ONE CASE OF FOOD IMPACTION IN THE STENT REQUIRING REPEAT ENDOSCOPIC INTERVENTION. FDA MDR REPORTING REQUIRED: THIS EVENT MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ SECTION 2.13 AND 2.15. DUE TO ONE CASE OF FOOD IMPACTION IN THE STENT REQUIRING REPEAT ENDOSCOPIC INTERVENTION.

    Additional Manufacturer Narrative · 1

    K162717: EXACT RPN EVO-E UNKNOWN, THIS IS THE MOST LIKELY US CLEARANCE NUMBER. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    TITLE OF LITERATURE REVIEW: ''ESOPHAGEAL STENT FIXATION WITH ENDOSCOPIC SUTURING DEVICE IMPROVES CLINICAL OUTCOMES AND REDUCES COMPLICATIONS IN PATIENTS WITH LOCALLY ADVANCED ESOPHAGEAL CANCER PRIOR TO NEOADJUVANT THERAPY: A LARGE MULTICENTER EXPERIENCE'' YANG ET AL 2016. AS INITIALLY REPORTED TO CUSTOMER RELATIONS VIA LITERATURE ARTICLE: LATE AES OCCURRED IN 2 PATIENTS AND INCLUDED ONE CASE OF FOOD IMPACTION IN THE STENT REQUIRING REPEAT ENDOSCOPIC INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1285038 UNKNOWN ESW PROSTHESIS, ESOPHAGEAL ESW COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention