BEUDAMED
    FDA Adverse Event Death Summary report: N

    WALLFLEX COLONIC SOFT STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEM

    MDR report key: 18580686 · Received January 25, 2024

    Report

    Report Number
    3005099803-2024-00123
    Event Type
    Death
    Date Received
    January 25, 2024
    Date of Event
    November 18, 2022
    Report Date
    February 23, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MQR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE EXACT DATE OF EVENT WAS NOT REPORTED. THE ARTICLE PUBLISHED DATE IS USED FOR THE ESTIMATED DATE OF EVENT. BLOCKS B5 AND H6 (IMPACT CODES) HAVE BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 1, 2024. BLOCK D4, H4: THE LITERATURE ARTICLE DID NOT PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK G2: LITERATURE SOURCE: PAPACHRYSOS, N., ET AL. "OUTCOME OF SELF-EXPANDABLE METAL STENTS PLACEMENT FOR OBSTRUCTIVE COLORECTAL CANCER: 7 YEARS' EXPERIENCE FROM A SWEDISH TERTIARY CENTER" SURGICAL ENDOSCOPY (2023) 37:2653-2658; DOI 10.1007/S00464-022-09761-2 BLOCK H6: IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF PATIENT'S DEATH. IMDRF IMPACT CODE F19 CAPTURES THE EMERGENCY SURGERY TO RESOLVE PATIENT'S BOWEL PERFORATION. IMDRF PATIENT CODE E1006 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF BOWEL PERFORATION.

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE EXACT DATE OF EVENT WAS NOT REPORTED. THE ARTICLE PUBLISHED DATE IS USED FOR THE ESTIMATED DATE OF EVENT. BLOCK D4, H4: THE LITERATURE ARTICLE DID NOT PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK G2: LITERATURE SOURCE: PAPACHRYSOS, N., ET AL. "OUTCOME OF SELF-EXPANDABLE METAL STENTS PLACEMENT FOR OBSTRUCTIVE COLORECTAL CANCER: 7 YEARS' EXPERIENCE FROM A SWEDISH TERTIARY CENTER" SURGICAL ENDOSCOPY (2023) 37:2653-2658; DOI 10.1007/S00464-022-09761-2. BLOCK H6: IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF PATIENT'S DEATH. IMDRF PATIENT CODE E1006 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF BOWEL PERFORATION.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF THE FOLLOWING EVENT THROUGH THE ARTICLE " OUTCOME OF SELF EXPANDABLE METAL STENTS PLACEMENT FOR OBSTRUCTIVE COLORECTAL CANCER: 7 YEARS' EXPERIENCE FROM A SWEDISH TERTIARY CENTER", BY PAPACHRYSOS, N., ET AL. THE STUDY AIMS TO REVIEW THE OUTCOMES OF SELF-EXPANDING METAL STENT (SEMS) TREATMENT IN A TERTIARY CENTER AND TO FIND PREDICTORS FOR THE CLINICAL OUTCOME. THE DATA WERE ANALYZED FROM SEMS INSERTION AT SAHLGRENSKA UNIVERSITY HOSPITAL, BETWEEN 2014 AND 2020. PATIENTS WERE IDENTIFIED THROUGH AN ADMINISTRATIVE DATABASE THAT CONTINUOUSLY REGISTERED ALL THE SEMS INSERTIONS. THE INCLUSION CRITERIA WERE COMPUTED TOMOGRAPHY (CT) SCAN VERIFIED ACUTE COLONIC OBSTRUCTION OR PROGRESSIVE OBSTRUCTIVE SYMPTOMS IN PATIENTS ALREADY DIAGNOSED WITH COLORECTAL CANCER. THE OBSTRUCTION WAS LOCATED FROM THE RIGHT COLON TO THE RECTUM. THE PURPOSE OF STENTING WAS EITHER PALLIATION OR BRIDGING TO SURGERY. ACCORDING TO THE LITERATURE, A TOTAL OF 265 SELF-EXPANDING METAL STENTS (SEMS) INSERTIONS (MEAN AGE 72, FEMALE 49.4%) WERE IDENTIFIED. MOST SEMS WERE USED FOR PALLIATION (90.2%). THE MALIGN OBSTRUCTION WAS MOST OFTEN LOCATED IN THE LEFT COLON (71.7%). ALL PROCEDURES WERE PERFORMED USING WALLFLEX COLONIC AND WALLFLEX SOFT STENTS UNCOVERED. PATIENTS WERE PLACED UNDER CONSCIOUS SEDATION. STENT DEPLOYMENT WAS PERFORMED OVER THE GUIDEWIRE BY THE THROUGH-THE-SCOPE TTS TECHNIQUE. CORRECT POSITIONING WAS ASSURED BY FLUOROSCOPY. ACCORDING TO THE ARTICLE ADVERSE EVENTS, ELEVEN PATIENTS (4.2%) HAD A PERFORATION DURING THE FIRST 48 POSTOPERATIVE HOURS AND WERE IMMEDIATELY EVALUATED BY A COLORECTAL SURGEON. THREE OF THE PERFORATIONS CAUSED THE PATIENTS' DEATH WITHIN FEW WEEKS AFTER THE SEMS INSERTION OF WHOM ONE IN THE BRIDGE TO SURGERY GROUP. AT THE END OF THE STUDY, THE SEMS RELATED MORTALITY WAS CALCULATED AT 1.1% (3/265), THE 30-DAYS MORTALITY RATE WAS 11.7% AND THE 90-DAY WAS 31.7%. MOST OF THE DEATHS WERE DUE TO COLORECTAL CANCER PROGRESS. ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 1, 2024: ACCORDING TO THE PHYSICIAN, THE PERFORATION WAS LOCATED IN THE MIDDLE OF THE STENT BODY WHERE THE TUMOR WAS LOCATED. THE PATIENT'S BOWEL PERFORATION WAS CONFIRMED VIA CT SCAN AND AN EMERGENCY SURGERY WAS PERFORMED TO TREAT THE PERFORATION.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF THE FOLLOWING EVENT THROUGH THE ARTICLE " OUTCOME OF SELF EXPANDABLE METAL STENTS PLACEMENT FOR OBSTRUCTIVE COLORECTAL CANCER: 7 YEARS' EXPERIENCE FROM A SWEDISH TERTIARY CENTER", BY PAPACHRYSOS, N., ET AL. THE STUDY AIMS TO REVIEW THE OUTCOMES OF SELF-EXPANDING METAL STENT (SEMS) TREATMENT IN A TERTIARY CENTER AND TO FIND PREDICTORS FOR THE CLINICAL OUTCOME. THE DATA WERE ANALYZED FROM SEMS INSERTION AT SAHLGRENSKA UNIVERSITY HOSPITAL, BETWEEN 2014 AND 2020. PATIENTS WERE IDENTIFIED THROUGH AN ADMINISTRATIVE DATABASE THAT CONTINUOUSLY REGISTERED ALL THE SEMS INSERTIONS. THE INCLUSION CRITERIA WERE COMPUTED TOMOGRAPHY (CT) SCAN VERIFIED ACUTE COLONIC OBSTRUCTION OR PROGRESSIVE OBSTRUCTIVE SYMPTOMS IN PATIENTS ALREADY DIAGNOSED WITH COLORECTAL CANCER. THE OBSTRUCTION WAS LOCATED FROM THE RIGHT COLON TO THE RECTUM. THE PURPOSE OF STENTING WAS EITHER PALLIATION OR BRIDGING TO SURGERY. ACCORDING TO THE LITERATURE, A TOTAL OF 265 SELF-EXPANDING METAL STENTS (SEMS) INSERTIONS (MEAN AGE 72, FEMALE 49.4%) WERE IDENTIFIED. MOST SEMS WERE USED FOR PALLIATION (90.2%). THE MALIGN OBSTRUCTION WAS MOST OFTEN LOCATED IN THE LEFT COLON (71.7%). ALL PROCEDURES WERE PERFORMED USING WALLFLEX COLONIC AND WALLFLEX SOFT STENTS UNCOVERED. PATIENTS WERE PLACED UNDER CONSCIOUS SEDATION. STENT DEPLOYMENT WAS PERFORMED OVER THE GUIDEWIRE BY THE THROUGH-THE-SCOPE TTS TECHNIQUE. CORRECT POSITIONING WAS ASSURED BY FLUOROSCOPY. ACCORDING TO THE ARTICLE ADVERSE EVENTS, ELEVEN PATIENTS (4.2%) HAD A PERFORATION DURING THE FIRST 48 POSTOPERATIVE HOURS AND WERE IMMEDIATELY EVALUATED BY A COLORECTAL SURGEON. THREE OF THE PERFORATIONS CAUSED THE PATIENTS' DEATH WITHIN FEW WEEKS AFTER THE SEMS INSERTION OF WHOM ONE IN THE BRIDGE TO SURGERY GROUP. AT THE END OF THE STUDY, THE SEMS RELATED MORTALITY WAS CALCULATED AT 1.1% (3/265), THE 30-DAYS MORTALITY RATE WAS 11.7% AND THE 90-DAY WAS 31.7%. MOST OF THE DEATHS WERE DUE TO COLORECTAL CANCER PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1317119 WALLFLEX COLONIC SOFT STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEM STENT, COLONIC, METALIC, EXPANDABLE MQR BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death