BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED

    MDR report key: 9473983 · Received December 16, 2019

    Report

    Report Number
    3001845648-2019-00733
    Event Type
    Injury
    Date Received
    December 16, 2019
    Date of Event
    February 3, 2015
    Report Date
    January 14, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    ESW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXACT RPN FOR THIS DEVICE IS UNKNOWN HOWEVER THE MOST LIKELY 510 K # IS THE FOLLOWING: K162717. DEVICE EVALUATION: THE EVO (EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED) 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 TO ADDRESS FOUR CASES OF TUMOUR OVERGROWTH. AMONG THE 47 PATIENTS, 37 HAD SELF-EXPANDING PARTIALLY COVERED METALLIC ESOPHAGEAL WALLFLEX STENTS (BOSTON SCIENTIFIC) INSERTED AND 10 HAD EVOLUTION STENTS (COOK) INSERTED. FORTY SEVEN PATIENTS UNDERWENT ENDOSCOPIC INSERTION OF AN ESOPHAGEAL STENT, RESULTS WERE THAT FOUR PATIENTS UNDERWENT RE-STENTING DUE TO PROXIMAL TUMOR. COMPLICATIONS IN THE GROUP OF PATIENTS WITH A 5-CM PROXIMAL TUMOR COVERING VS. OTHERS, LISTED IN TABLE 2. THEREFORE, WE CANNOT CONFIRM THAT THE COOK EVOLUTION STENT WAS RELATED TO THIS COMPLAINT AS THE NUMBER OF COMPLICATIONS AND TYPE OF COMPLICATIONS ARE NOT INDICATING TYPE OF STENT USED. DOCUMENTS REVIEW INCLUDING IFU REVIEW: AS THE EVO (EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED) DEVICE FROM UNKNOWN LOT NUMBER, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. PRIOR TO DISTRIBUTION ALL EVO (EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED) 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, TUMOR INGROWTH OR OVERGROWTH ARE LISTED AS A COMPLICATION FOLLOWING THE PLACEMENT OF THIS DEVICE. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE PATIENT OUTCOME IS UNKNOWN. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    COMPLAINT RECEIVED FROM INTERNAL PERSONNEL VIA E-MAIL ON 03DEC2019--DID 04DEC2019. TAHIRI ET AL 2015-"SELF-EXPANDING METALLIC STENT PLACEMENT WITH AN EXAGGERATED 5-CM PROXIMAL TUMOR COVERING FOR PALLIATION OF ESOPHAGEAL CANCER." AS REPORTED TO CUSTOMER RELATIONS: "FOUR PATIENTS UNDERWENT RESTENTING FOR PROXIMAL TUMOR OVERGROWTH. THESE 4 PATIENTS DID NOT RECEIVE ANY CONCOMITANT TREATMENT OF CHEMOTHERAPY OR RADIOTHERAPY. TUMOR OVERGROWTH WAS TREATED IN ALL THE CASES WITH THE PLACEMENT OF AN ADDITIONAL STENT TO COVER THE TUMOR OVERGROWTH." TWO TYPES OF PARTIALLY COVERED SEMS WERE USED IN THIS LITERATURE REVIEW; WALLFLEX ESOPHAGEAL STENT (BOSTON SCIENTIFIC) AND THE EVOLUTION STENT (COOK MEDICAL). AS IT CANNOT BE CONFIRMED THAT COOK EVOLUTION STENT WAS RELATED TO THE 4 CASES OF TUMOR OVERGROWTH, WE ARE TREATING THIS AS A CONSERVATIVE ASSESSMENT. MOC 16-DEC-2019.

    Additional Manufacturer Narrative · 1

    K162717 - US CLEARANCE NUMBER. CANNOT BE CONFIRMED OF EXACT RPN OF DEVICE POSSIBLY USED SO THIS IS AN ASSUMED 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

    COMPLAINT RECEIVED FROM INTERNAL PERSONNEL VIA E-MAIL ON 03DEC2019--DID 04DEC2019. TAHIRI ET AL 2015-"SELF-EXPANDING METALLIC STENT PLACEMENT WITH AN EXAGGERATED 5-CM PROXIMAL TUMOR COVERING FOR PALLIATION OF ESOPHAGEAL CANCER". AS REPORTED TO CUSTOMER RELATIONS: "FOUR PATIENTS UNDERWENT RESTENTING FOR PROXIMAL TUMOR OVERGROWTH. THESE 4 PATIENTS DID NOT RECEIVE ANY CONCOMITANT TREATMENT OF CHEMOTHERAPY OR RADIOTHERAPY. TUMOR OVERGROWTH WAS TREATED IN ALL THE CASES WITH THE PLACEMENT OF AN ADDITIONAL STENT TO COVER THE TUMOR OVERGROWTH." TWO TYPES OF PARTIALLY COVERED SEMS WERE USED IN THIS LITERATURE REVIEW; WALLFLEX ESOPHAGEAL STENT (BOSTON SCIENTIFIC) AND THE EVOLUTION STENT (COOK MEDICAL). AS IT CANNOT BE CONFIRMED THAT COOK EVOLUTION STENT WAS RELATED TO THE 4 CASES OF TUMOR OVERGROWTH, WE ARE TREATING THIS AS A CONSERVATIVE ASSESSMENT. MOC 16-DEC-2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1266459 EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED ESW PROSTHESIS, ESOPHAGEAL ESW COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention