BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED

    MDR report key: 10936565 · Received December 2, 2020

    Report

    Report Number
    3001845648-2020-00909
    Event Type
    Injury
    Date Received
    December 2, 2020
    Date of Event
    November 2, 2020
    Report Date
    May 18, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    ESW
    UDI-DI
    10827002480312
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE EVO-20-25-10-E DEVICE OF LOT NUMBER C1708721 INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. DOCUMENTS REVIEW INCLUDING IFU REVIEW: PRIOR TO DISTRIBUTION ALL EVO-20-25-10-E DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THERE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. A REVIEW OF THE MANUFACTURING RECORDS FOR EVO-20-25-10-E DEVICE OF LOT NUMBER C1708721 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE AFFECTS THE ENTIRE LOT #C1708721; UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT #C1708721. AS PER THE INSTRUCTIONS FOR USE, IFU0061-6, WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO: "IF STENT REPOSITIONING IS REQUIRED DURING DEPLOYMENT, IT IS POSSIBLE TO RECAPTURE STENT. NOTE: IT IS NOT POSSIBLE TO RECAPTURE STENT AFTER PASSING POINT-OF-NO-RETURN, INDICATED WHEN RED MARKER ON TOP OF INTRODUCER HAS PASSED THE POINT-OF-NO-RETURN INDICATOR ON HANDLE." THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. AS PER COMPLAINT DESCRIPTION "THE PHYSICIAN BEGINS TO DEPLOY THE STENT UNTIL THE RED BUTTON REACHES THE "POINT OF NO RETURN" THE STYLET WAS COMPLETELY REMOVED AND THE DELIVERY CONTINUES UNTIL THE END. AT THE TIME OF REMOVING THE DEPLOYMENT SYSTEM THE STENT WASN´T SEPARATE FROM THEM SO THE DOCTOR PUSHED THE BUTTON AND RECAPTURES ABOUT 4CM TRYING TO RELEASE THE STENT BUT NOTHING HAPPENED, " THEREFORE ADDITIONAL COMPLAINT FILE PR(B)(4) WAS RAISED TO CAPTURE USER ERROR DUE TO ATTEMPTING TO RECAPTURE THE DEVICE AFTER PASSING THE POINT OF NO RETURN. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED THE DIFFICULT TARGET SITE WHICH COULD LEAD TO A STENT GETTING CAUGHT UP ON THE DELIVERY SYSTEM TIP. HOWEVER, AS THE DEVICE WAS NOT RETURNED FOR EVALUATION; THE CAUSE OF THIS COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. SUMMARY: COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER¿S TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT BEING SUBMITTED DUE TO THE INVESTIGATION BEING COMPLETED ON (B)(6)2021. AS REPORTED TO CUSTOMER RELATIONS VIA COMPLAINT FORM "ENDOSCOPY WAS PERFORMED, THE DOCTOR PERFORMED A ESOPHAGEAL DILATION WITH HERCULES BALLOON UNTIL 15MM, THEN THE TUMOR IS MARKED AND SAVARY WIRE GUIDE WAS INSTALLED. WITH RX THE STENT IS ADVANCED THROUGH THE WIRE GUIDE AND PLACED IN POSITION. THE PHYSICIAN BEGINS TO DEPLOY THE STENT UNTIL THE RED BUTTON REACHES THE "POINT OF NO RETURN" THE STYLET WAS COMPLETELY REMOVED AND THE DELIVERY CONTINUES UNTIL THE END. AT THE TIME OF REMOVING THE DEPLOYMENT SYSTEM THE STENT WASN´T SEPARATE FROM THEM SO THE DOCTOR PUSHED THE BUTTON AND RECAPTURES ABOUT 4CM TRYING TO RELEASE THE STENT BUT NOTHING HAPPENED, A SECOND ATTEMPT IS MADE TO RELEASE IT BUT IT STILL ATTACHED TO DEPLOYMENT SYSTEM, THE DOCTOR MOVES ALL THE SYSTEM AND FINALLY THE STENT WAS RELEASED BUT NOT IN PLACE, WITH ALLIGATOR JAW FORCEPS WAS REPOSITIONED." DID ANY SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? - NO. · PLEASE DESCRIBE THE OBJECT AND HOW IT WAS RETRIEVED: DID THE PATIENT EXPERIENCE A DELAY OR REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE? - NO. · PLEASE SPECIFY DELAY OR ANY ADDITIONAL PROCEDURE(S) AND PROVIDE DETAILS: HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? - NO. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? - NO. · PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: K162717. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    AS REPORTED TO CUSTOMER RELATIONS VIA COMPLAINT FORM "ENDOSCOPY WAS PERFORMED, THE DOCTOR PERFORMED A ESOPHAGEAL DILATION WITH HERCULES BALLOON UNTIL 15MM, THEN THE TUMOR IS MARKED AND SAVARY WIRE GUIDE WAS INSTALLED. WITH RX THE STENT IS ADVANCED THROUGH THE WIRE GUIDE AND PLACED IN POSITION. THE PHYSICIAN BEGINS TO DEPLOY THE STENT UNTIL THE RED BUTTON REACHES THE "POINT OF NO RETURN" THE STYLET WAS COMPLETELY REMOVED AND THE DELIVERY CONTINUES UNTIL THE END. AT THE TIME OF REMOVING THE DEPLOYMENT SYSTEM THE STENT WASN´T SEPARATE FROM THEM SO THE DOCTOR PUSHED THE BUTTON AND RECAPTURES ABOUT 4CM TRYING TO RELEASE THE STENT BUT NOTHING HAPPENED, A SECOND ATTEMPT IS MADE TO RELEASE IT BUT IT STILL ATTACHED TO DEPLOYMENT SYSTEM, THE DOCTOR MOVES ALL THE SYSTEM AND FINALLY THE STENT WAS RELEASED BUT NOT IN PLACE, WITH ALLIGATOR JAW FORCEPS WAS REPOSITIONED." DID ANY SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. PLEASE DESCRIBE THE OBJECT AND HOW IT WAS RETRIEVED: DID THE PATIENT EXPERIENCE A DELAY OR REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE? NO. PLEASE SPECIFY DELAY OR ANY ADDITIONAL PROCEDURE(S) AND PROVIDE DETAILS: HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? NO. PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1400000 EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED ESW PROSTHESIS, ESOPHAGEAL ESW COOK IRELAND LTD G48031 C1708721 10827002480312

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention