BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 12894227 · Received November 30, 2021

    Report

    Report Number
    3001845648-2021-00825
    Event Type
    Injury
    Date Received
    November 30, 2021
    Date of Event
    March 17, 2021
    Report Date
    March 24, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    ESW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: K093619. DEVICE EVALUATION: THE EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED DEVICE OF UNKNOWN RPN AND LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE TO CAPTURE ¿CARTER ¿ OFF LABEL USE: EVO-E USED TO TREAT ANASTOMOTIC LEAKS + STENT MIGRATION¿. DOCUMENT REVIEW INCLUDING IFU REVIEW: AS THE DEVICE IS FROM UNKNOWN RPN AND LOT NUMBER, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. PRIOR TO DISTRIBUTION, ALL EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. THE INSTRUCTIONS FOR USE (IFU0061) INSTRUCTS THE USER THAT THE INTENDED USE OF THIS DEVICE IS" TO MAINTAIN PATENCY OF MALIGNANT ESOPHAGEAL STRICTURES AND/OR TO SEAL TRACHEOESOPHAGEAL FISTULAS". THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. THE PURPOSE OF THE STUDY "WAS TO PRESENT THE OPTIMAL PATIENT SELECTION FOR ESOPHAGEAL STENTING AFTER ESOPHAGEAL RESECTION". THE USE OF THESE DEVICES TO TREAT ANASTOMOTIC LEAKS RESULTING FROM ESOPHAGEAL RESECTIONS IS OUTSIDE THE INTENDED USE OF THESE DEVICES. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD BE DETERMINED FROM THE AVAILABLE INFORMATION. FROM THE JOURNAL ARTICLE IT IS KNOWN THAT THE USER USED THE DEVICE OFF-LABEL. AS PER MEDICAL ADVISOR¿S INPUT ¿I CAN CONFIRM THAT THIS DEATH WAS NOT STENT RELATED. TREATING ANASTOMOTIC LEAKS AFTER ESOPHAGOGASTRECTOMY WOULD BE CONSIDERED OFF-LABEL USE OF THE STENT. SUMMARY: COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER'S TESTIMONY. PATIENT BEGAN WITH AN EVOLUTION STENT AND REQUIRED AN ADDITIONAL ENDOMAXX STENT SECONDARY TO EARLY MIGRATION OF THE EVOLUTION STENT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. PMA/510(K) #: K093619.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    CARTER ET AL 2021 (EVO-E) ¿ ¿OUTCOMES OF ESOPHAGEAL STENT THERAPY FOR THE MANAGEMENT OF ANASTOMOTIC LEAKS¿. APPROXIMATELY 5CM BELOW THE LEAK IN THE GASTRIC CONDUIT A CLIP (RESOLUTION, BOSTON SCIENTIFIC) IS PLACED FOR PRECISE DISTAL LOCATION OF THE STENT. DEPENDING ON THE LENGTH OF THE PROXIMAL ESOPHAGUS, A 120-MM OR 150-MM LENGTH IS UTILIZED WITH AN OUTER DIAMETER OF AT LEAST 23 MM AND PROXIMAL FLANGE OF EITHER 27 MM OR 28 MM IN DIAMETER. ALL STENTS UTILIZED ARE FULL COVERED STENTS. EVOLUTION (N = 2) THE STENT IS RELEASED UNDER FLUOROSCOPIC VISION AND THEN CONFIRMED WITH REPEAT ENDOSCOPY TO ENSURE THE MAXIMAL PROXIMAL APPOSITION OF THE STENT TO THE ESOPHAGUS TO MAXIMIZE EXCLUSION OF THE LEAK. IF THERE IS STILL GAPPING AROUND THE PROXIMAL STENT FLANGE, THEN CON-SIDERATION OF PLACING ANOTHER STENT MORE PROXIMAL IS PERFORMED WITH THE GOAL FOR COMPLETE EXCLUSION AND TO ENSURE THE TOP OF THE STENT IS C2 CM FROM THE CRICOPHARYNGEAL. ALL STENTS WERE LEFT IN PLACE FOR 3-MONTH DURATION. AT THAT TIME, PATIENTS HAD STENTS REMOVED AND EVALUATED FOR COMPLETE LEAK RESOLUTION BY ENDOSCOPIC EVALUATION. IF PERSISTENT, THEN REPEAT STENT WAS PLACED. OFF LABEL USE: EVO-E USED TO TREAT ANASTOMOTIC LEAKS. ONE PATIENT BEGAN WITH AN EVOLUTION STENT AND REQUIRED AN ADDITIONAL ENDOMAXX STENT SECONDARY TO EARLY MIGRATION OF THE EVOLUTION STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1792722 EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED ESW PROSTHESIS, ESOPHAGEAL ESW COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention