BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 18100251 · Received November 9, 2023

    Report

    Report Number
    3001845648-2023-00825
    Event Type
    Injury
    Date Received
    November 9, 2023
    Report Date
    August 1, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    ESW
    UDI-DI
    10827002551715
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #K093619. DEVICE EVALUATION THE EVO-FC-R-20-25-10-E DEVICE OF LOT NUMBER C1472259 INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED IN RESPONSE TO THE ATTACHED (B)(4) STUDY. MANUFACTURING RECORDS REVIEW: PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. HISTORICAL DATA REVIEW: THE REVIEW OF THE RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED FOR THIS WORK ORDER. INSTRUCTIONS FOR USE AND/LABEL REVIEW: IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0067) LISTS ¿STENT MISPLACEMENT AND/OR MIGRATION¿ AS A POTENTIAL ADVERSE EVENT. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE OR PRODUCT LABEL. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT CONDITIONS. THE STENT MIGRATION MAY HAVE OCCURRED AS A RESULT OF THE REDUCTION/DISAPPEARANCE OF THE MALIGNANT OBSTRUCTION WHICH THE STENT WAS PLACED TO TREAT. FROM THE STUDY IT WAS NOTED THAT THERE WAS NO VISIBLE STENOSIS. AS PREVIOUSLY NOTED, STENT MIGRATION IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE DEVICE. CONFIRMATION OF COMPLAINT: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CONFIRMED QUANTITY OF 01 X USED DEVICE. CORRECTIVE ACTION/CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS. SUMMARY OF INVESTIGATION: FROM THE LITERATURE PAPER, THE EVO-FC-R-20-25-10-E STENT MIGRATED INTO THE STOMACH IN 01 PATIENT. ACCORDING TO THE INITIAL REPORTER, THE STENT WAS REMOVED ENDOSCOPICALLY, THE STENT WAS NOT REPLACED AS THE STENT WAS NO LONGER NEEDED. THE PATIENT RECOVERED/STABILISED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 01-AUG-2024.

    Description of Event or Problem · 0

    DEVICE ISSUE: STENT MIGRATION; RELATIONSHIP QUESTIONS STUDY DEVICE: BLANK, PROCEDURE: NOT RELATED. AS PER ATTACHED PATIENT CASEBOOK, "1. DATE OF PROCEDURE: (B)(6) 2018; 2. REASON FOR STENT PLACEMENT: MALIGNANT OBSTRUCTION (INSTRINSIC); 3. MORPHOLOGY OF STUDY LESION: LENGTH OF STUDY LESION 5 CM; DIAMETER OF ESOPHAGUS AT THE LOCATION OF THE STUDY LESION 5MM". "POST-PROCEDURAL INFORMATION: 3. WERE ANY ACID REDUCING MEDICATIONS DOCUMENTED DURING FOLLOW UP? YES, MEDICATION BEING TAKEN (PROTON PUMP INHIBITOR) 4. WAS TUMOR-REDUCTION THERAPY DOCUMENTED DURING FOLLOW UP? NO 5. WERE THERE ANY MEDICAL PROBLEMS OR COMPLICATIONS DOCUMENTED AFTER THE STUDY PROCEDURE AND THROUGH FOLLOW-UP MEDICAL RECORD REVIEW? YES 6. WERE ANY DEVICE DEFICIENCIES DOCUMENTED AFTER THE STUDY PROCEDURE AND THROUGH FOLLOW-UP MEDICAL RECORD REVIEW; INCLUDING DEVICE DEFICIENCIES THAT MAY HAVE OCCURRED DURING STENT REPOSITIONING OR REMOVAL? NO" "STATUS OF STUDY STENT ONLY (INITIAL STENT PLACED DURING THE STUDY PROCEDURE): 1. AT THE CONCLUSION OF FOLLOW-UP WHAT WAS THE STATUS OF THE STUDY STENT: STENT REMOVED ENDOSCOPICALLY. DAYS POST STENT PLACEMENT: 141. REASON FOR REMOVAL: ADVERSE EVENT ". "6. WERE ANY ADDITIONAL PROCEDURE (S) PERFORMED DURING THE STUDY PROCEDURE? YES, LIPIODOL-MARKING BEFORE PROCEDURE 7. WERE ANY ADVERSE EVENTS DOCUMENTED DURING THE STENT PROCEDURE? NO 8. WERE ANY DEVICE DEFICIENCIES DOCUMENTED DURING THE PLACEMENT PROCEDURE? NO" "1. EVENT STATUS AT TIME OF STUDY EXIT: RESOLVED (PATIENT RECOVERED/STABILIZED) 3. EVENT CATEGORY: DEVICE ISSUES - STENT MIGRATION, CONFIRMED BY ENDOSCOPY, DIRECTION OF MIGRATION: DISTAL, DEGREE OF MIGRATION: TO STOMACH, DID NOT LEAD TO INTESTINAL OBSTRUCTION WHAT ARE THE CONTRIBUTING FACTORS THAT LED TO THE MIGRATION? DISLOCATED INTO THE STOMACH, NO VISIBLE STENOSIS. WERE ANY OF THE FOLLOWING SYMPTOMS OR CONDITIONS DOCUMENTED IN THE MEDICAL RECORD? YES (GENERAL CONDITION VERY MUCH DETERIORATED) WAS THE STENT REPOSITIONED OR REPLACED? NO. IF NO, PROVIDE REASON: STENT NO LONGER NEEDED. 4. EVENT TREATMENT: ENDOSCOPIC (STUDY STENT REMOVED) 5. WAS THE EVENT CONSIDERED TO BE RELATED TO THE STUDY PROCEDURE? NOT RELATED 6. DID THE EVENT LEAD TO PATIENT DEATH? NO" STATUS: RESOLVED. TREATMENT: ENDOSCOPIC; STUDY STENT REMOVED. DEATH: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1803547 EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED ESW PROSTHESIS, ESOPHAGEAL ESW COOK IRELAND LTD C1472259 10827002551715

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention