AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
Report
- Report Number
- 3005099803-2023-06085
- Event Type
- Injury
- Date Received
- November 9, 2023
- Date of Event
- September 6, 2023
- Report Date
- March 14, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- PCU
- UDI-DI
- 08714729951179
- PMA / PMN Number
- K220112
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK A4: PATIENT'S WEIGHT: 45.9 KGS. BLOCKS B5 AND B6 HAVE BEEN UPDATED WITH THE ADDITIONAL INFORMATION RECEIVED ON NOVEMBER 15 AND 16, 2023. BLOCK E1: INITIAL REPORTER'S ADDRESS: (B)(6). BLOCK G2: REPORT SOURCE: E7127 PASSAGE CLINICAL STUDY. BLOCK H6: IMDRF DEVICE CODE A0106 CAPTURES THE REPORTABLE EVENT OF STENT OBSTRUCTION WITHIN DEVICE. IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF PROLONGED INDEX HOSPITALIZATION. IMDRF IMPACT CODE F2202 CAPTURES THE REPORTABLE EVENT OF REINTERVENTION PROCEDURE. IMDRF IMPACT CODE F2203 CAPTURES THE REPORTABLE EVENT OF CONTRAST IMAGING REVEALED BLOCKAGE OF THE STENT. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF USING STOMACH TUBE WAS PERFORMED.
BLOCK A4: PATIENT'S WEIGHT: 45.9 KGS. BLOCKS B5 AND H6 HAVE BEEN UPDATED WITH THE ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 21 AND 22, 2024. BLOCK E1: INITIAL REPORTER'S ADDRESS: (B)(6). BLOCK G2: REPORT SOURCE: (B)(6) PASSAGE CLINICAL STUDY. BLOCK H6: IMDRF DEVICE CODE A0106 CAPTURES THE REPORTABLE EVENT OF STENT OBSTRUCTION WITHIN DEVICE. IMDRF PATIENT CODE E2338 CAPTURES THE REPORTABLE EVENT OF EDEMA. IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF PROLONGED INDEX HOSPITALIZATION. IMDRF IMPACT CODE F2202 CAPTURES THE REPORTABLE EVENT OF REINTERVENTION PROCEDURE. IMDRF IMPACT CODE F2203 CAPTURES THE REPORTABLE EVENT OF CONTRAST IMAGING REVEALED BLOCKAGE OF THE STENT. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF USING STOMACH TUBE WAS PERFORMED.
BLOCK A4: PATIENT'S WEIGHT: 45.9 KGS. BLOCKS B5 AND H6 HAVE BEEN UPDATED WITH THE ADDITIONAL INFORMATION RECEIVED ON DECEMBER 18 AND 22, 2023. BLOCK E1: INITIAL REPORTER'S ADDRESS: (B)(6). BLOCK G2: REPORT SOURCE: E7127 PASSAGE CLINICAL STUDY. BLOCK H6: IMDRF DEVICE CODE A0106 CAPTURES THE REPORTABLE EVENT OF STENT OBSTRUCTION WITHIN DEVICE IMDRF PATIENT CODE E2338 CAPTURES THE REPORTABLE EVENT OF EDEMA. IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF PROLONGED INDEX HOSPITALIZATION. IMDRF IMPACT CODE F2202 CAPTURES THE REPORTABLE EVENT OF REINTERVENTION PROCEDURE. IMDRF IMPACT CODE F2203 CAPTURES THE REPORTABLE EVENT OF CONTRAST IMAGING REVEALED BLOCKAGE OF THE STENT. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF USING STOMACH TUBE WAS PERFORMED.
BLOCK A4: PATIENT'S WEIGHT: 45.9 KGS. BLOCK E1: INITIAL REPORTER'S ADDRESS: (B)(6). BLOCK G2: REPORT SOURCE: E7127 PASSAGE CLINICAL STUDY. BLOCK H6: IMDRF DEVICE CODE A0106 CAPTURES THE REPORTABLE EVENT OF STENT OBSTRUCTION WITHIN DEVICE. IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF PROLONGED INDEX HOSPITALIZATION. IMDRF IMPACT CODE F2202 CAPTURES THE REPORTABLE EVENT OF REINTERVENTION PROCEDURE. IMDRF IMPACT CODE F2203 CAPTURES THE REPORTABLE EVENT OF CONTRAST IMAGING REVEALED BLOCKAGE OF THE STENT. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF USING STOMACH TUBE WAS PERFORMED.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM IMPLANTED IN THE JEJUNUM TO TREAT A GASTRIC OUTLET OBSTRUCTION ON (B)(6) 2023, AS PART OF THE, E7127 PASSAGE CLINICAL STUDY. THE PATIENT WAS ENROLLED IN THE CLINICAL TRIAL ON (B)(6) 2023. ON (B)(6) 2023, 5 DAYS POST STENT PLACEMENT, THE PATIENT EXPERIENCED NAUSEA AND THE PATIENT'S HOSPITALIZATION WAS PROLONGED. PATIENT'S NAUSEA WAS NOT RELATED TO THE DEVICE. ON (B)(6) 2023, A CONTRAST IMAGING REVEALED A BLOCKAGE OF THE STENT END DUE TO THE LOCATION OF THE JEJUNUM. REINTERVENTION PROCEDURE USING A STOMACH TUBE WAS PERFORMED ON THE SAME DAY. ON (B)(6) 2023, THE EVENT WAS CONSIDERED RESOLVED/RECOVERED. ON (B)(6) 2023, 35 DAYS POST STENT PLACEMENT, THE PATIENT'S PANCREATIC HEAD CANCER WAS NOTED TO HAVE WORSENED. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED AND WAS TREATED MEDICALLY. ON (B)(6) 2023, 44 DAYS POST STENT PLACEMENT, THE PATIENT PASSED AWAY DUE TO PROGRESSION OF PANCREATIC HEAD CANCER. ADDITIONAL INFORMATION RECEIVED ON NOVEMBER 15 AND 16, 2023: ON (B)(6) 2023, THE STOMACH TUBE WAS USED TO TREAT THE CURRENT GASTRIC OUTLET OBSTRUCTION. NAUSE IS THE FINAL DIAGNOSIS AND IS JUDGED TO BE DUE TO THE PATIENT'S ANATOMY OF DIGESTIVE TRACT AND NOT RELATED TO THE DEVICE. ON (B)(6) 2023, CT SCAN REVEALED LARGE AMOUNT OF GASTRIC RESIDUE IN STOMACH, TO WHICH MEAL WAS STOPPED TEMPORARILY AND ACOFIDE AND RIKKUNSHITO WERE STARTED. ON (B)(6) 2023, THE STENT WAS PLACED AS ACTION TAKEN. ON (B)(6) 2023, THE SUBJECT PASSED AWAY AT 6:58 PM IN HOSPITAL. PER DEATH CERTIFICATE, CAUSE OF DEATH WAS CANCER OF HEAD OF PANCREAS AND AUTOPSY WAS NOT PERFORMED.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM IMPLANTED IN THE JEJUNUM TO TREAT A GASTRIC OUTLET OBSTRUCTION ON (B)(6) 2023, AS PART OF THE, (B)(6) PASSAGE CLINICAL STUDY. THE PATIENT WAS ENROLLED IN THE CLINICAL TRIAL ON (B)(6) 2023. ON (B)(6) 2023, 5 DAYS POST STENT PLACEMENT, THE PATIENT EXPERIENCED NAUSEA AND THE PATIENT'S HOSPITALIZATION WAS PROLONGED. PATIENT'S NAUSEA WAS NOT RELATED TO THE DEVICE. ON (B)(6) 2023, A CONTRAST IMAGING REVEALED A BLOCKAGE OF THE STENT END DUE TO THE LOCATION OF THE JEJUNUM. REINTERVENTION PROCEDURE USING A STOMACH TUBE WAS PERFORMED ON THE SAME DAY. ON (B)(6) 2023, THE EVENT WAS CONSIDERED RESOLVED/RECOVERED. ON (B)(6) 2023, 35 DAYS POST STENT PLACEMENT, THE PATIENT'S PANCREATIC HEAD CANCER WAS NOTED TO HAVE WORSENED. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED AND WAS TREATED MEDICALLY. ON (B)(6) 2023, 44 DAYS POST STENT PLACEMENT, THE PATIENT PASSED AWAY DUE TO PROGRESSION OF PANCREATIC HEAD CANCER. ADDITIONAL INFORMATION RECEIVED ON NOVEMBER 15 AND 16, 2023: ON (B)(6) 2023, THE STOMACH TUBE WAS USED TO TREAT THE CURRENT GASTRIC OUTLET OBSTRUCTION. NAUSE IS THE FINAL DIAGNOSIS AND IS JUDGED TO BE DUE TO THE PATIENT'S ANATOMY OF DIGESTIVE TRACT AND NOT RELATED TO THE DEVICE. ON (B)(6) 2023, CT SCAN REVEALED LARGE AMOUNT OF GASTRIC RESIDUE IN STOMACH, TO WHICH MEAL WAS STOPPED TEMPORARILY AND ACOFIDE AND RIKKUNSHITO WERE STARTED. ON (B)(6) 2023, THE STENT WAS PLACED AS ACTION TAKEN. ON (B)(6) 2023, THE SUBJECT PASSED AWAY AT 6:58 PM IN HOSPITAL. PER DEATH CERTIFICATE, CAUSE OF DEATH WAS CANCER OF HEAD OF PANCREAS AND AUTOPSY WAS NOT PERFORMED. ADDITIONAL INFORMATION RECEIVED ON DECEMBER 18 AND 22, 2023: IT WAS CONFIRMED THAT THE "NEW STENT PLACEMENT WAS PERFORMED THROUGH THE STUDY STENT." ON (B)(6) 2023, IT WAS NOTED THAT MEAL DID NOT FLOW TO THE EFFERENT LOOP. THEREFORE, FOR THE PURPOSE OF ADJUSTMENT, THE INTESTINAL TRACT ON THE ANAL SIDE FROM THE INSIDE OF THE AXIOS WAS EXAMINED BY ENDOSCOPY, ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CATHETER AND GUIDEWIRE USING SHORT SINGLE BALLOON ENTEROSCOPE (SBE), BUT IT COULD NOT BE IDENTIFIED. THE STENOTIC AREA OF THE DUODENAL BULB WAS THEN DILATED WITH A CRE BALLOON 20 MM, AND THE ENDOSCOPE WAS FURTHER ADVANCED BY PASSING THROUGH THE STENOTIC AREA BY WEDGING IN THE DEEPER PART. THE ENDOSCOPE WAS ADVANCED TO THE ANASTOMOTIC SITE, AND THE EDEMATOUS INTESTINAL TRACT WAS IDENTIFIED WITH AXIOS STENT. ON THE SAME DAY, A DIFFERENT DUODENAL STENT WAS PLACED, BY BRIDGING THE JEJUNUM ON THE ANAL SIDE FROM INSIDE THE AXIOS STENT. ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 21 AND 22, 2024: ON (B)(6) 2024, THE STOMACH TUBE WAS PLACED AS AN ACTION TAKEN TO TREAT THE EVENT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM IMPLANTED IN THE JEJUNUM TO TREAT A GASTRIC OUTLET OBSTRUCTION ON SEPTEMBER 01, 2023, AS PART OF THE, E7127 PASSAGE CLINICAL STUDY. THE PATIENT WAS ENROLLED IN THE CLINICAL TRIAL ON (B)(6) 2023. ON (B)(6) 2023, 5 DAYS POST STENT PLACEMENT, THE PATIENT EXPERIENCED NAUSEA AND THE PATIENT'S HOSPITALIZATION WAS PROLONGED. PATIENT'S NAUSEA WAS NOT RELATED TO THE DEVICE. ON (B)(6) 2023, A CONTRAST IMAGING REVEALED A BLOCKAGE OF THE STENT END DUE TO THE LOCATION OF THE JEJUNUM. REINTERVENTION PROCEDURE USING A STOMACH TUBE WAS PERFORMED ON THE SAME DAY. ON (B)(6) 2023, THE EVENT WAS CONSIDERED RESOLVED/RECOVERED. ON (B)(6) 2023, 35 DAYS POST STENT PLACEMENT, THE PATIENT'S PANCREATIC HEAD CANCER WAS NOTED TO HAVE WORSENED. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED AND WAS TREATED MEDICALLY. ON (B)(6) 2023, 44 DAYS POST STENT PLACEMENT, THE PATIENT PASSED AWAY DUE TO PROGRESSION OF PANCREATIC HEAD CANCER. ***ADDITIONAL INFORMATION RECEIVED ON NOVEMBER 15 AND 16, 2023*** ON (B)(6) 2023, THE STOMACH TUBE WAS USED TO TREAT THE CURRENT GASTRIC OUTLET OBSTRUCTION. NAUSE IS THE FINAL DIAGNOSIS AND IS JUDGED TO BE DUE TO THE PATIENT'S ANATOMY OF DIGESTIVE TRACT AND NOT RELATED TO THE DEVICE. ON (B)(6) 2023, CT SCAN REVEALED LARGE AMOUNT OF GASTRIC RESIDUE IN STOMACH, TO WHICH MEAL WAS STOPPED TEMPORARILY AND ACOFIDE AND RIKKUNSHITO WERE STARTED. ON (B)(6) 2023, THE STENT WAS PLACED AS ACTION TAKEN. ON (B)(6) 2023, THE SUBJECT PASSED AWAY AT 6:58 PM IN HOSPITAL. PER DEATH CERTIFICATE, CAUSE OF DEATH WAS CANCER OF HEAD OF PANCREAS AND AUTOPSY WAS NOT PERFORMED. ***ADDITIONAL INFORMATION RECEIVED ON DECEMBER 18 AND 22, 2023*** IT WAS CONFIRMED THAT THE "NEW STENT PLACEMENT WAS PERFORMED THROUGH THE STUDY STENT." ON (B)(6) 2023, IT WAS NOTED THAT MEAL DID NOT FLOW TO THE EFFERENT LOOP. THEREFORE, FOR THE PURPOSE OF ADJUSTMENT, THE INTESTINAL TRACT ON THE ANAL SIDE FROM THE INSIDE OF THE AXIOS WAS EXAMINED BY ENDOSCOPY, ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CATHETER AND GUIDEWIRE USING SHORT SINGLE BALLOON ENTEROSCOPE (SBE), BUT IT COULD NOT BE IDENTIFIED. THE STENOTIC AREA OF THE DUODENAL BULB WAS THEN DILATED WITH A CRE BALLOON 20 MM, AND THE ENDOSCOPE WAS FURTHER ADVANCED BY PASSING THROUGH THE STENOTIC AREA BY WEDGING IN THE DEEPER PART. THE ENDOSCOPE WAS ADVANCED TO THE ANASTOMOTIC SITE, AND THE EDEMATOUS INTESTINAL TRACT WAS IDENTIFIED WITH AXIOS STENT. ON THE SAME DAY, A DIFFERENT DUODENAL STENT WAS PLACED, BY BRIDGING THE JEJUNUM ON THE ANAL SIDE FROM INSIDE THE AXIOS STENT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM IMPLANTED IN THE JEJUNUM TO TREAT A GASTRIC OUTLET OBSTRUCTION ON (B)(6) 2023, AS PART OF THE, E7127 PASSAGE CLINICAL STUDY. THE PATIENT WAS ENROLLED IN THE CLINICAL TRIAL ON (B)(6) 2023. ON SEPTEMBER 06, 2023,, 5 DAYS POST STENT PLACEMENT, THE PATIENT EXPERIENCED NAUSEA AND THE PATIENT'S HOSPITALIZATION WAS PROLONGED. PER THE PHYSICIAN'S ASSESSMENT, PATIENT'S NAUSEA IS NOT RELATED TO THE DEVICE. ON (B)(6) 2023, A CONTRAST IMAGING REVEALED A BLOCKAGE OF THE STENT END DUE TO THE LOCATION OF THE JEJUNUM. REINTERVENTION PROCEDURE USING A STOMACH TUBE WAS PERFORMED ON THE SAME DAY. ON (B)(6) 2023, THE EVENT WAS CONSIDERED RESOLVED/RECOVERED. ON (B)(6) 2023, 35 DAYS POST STENT PLACEMENT, THE PATIENT'S PANCREATIC HEAD CANCER WAS NOTED TO HAVE WORSENED. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED AND WAS TREATED MEDICALLY. ON (B)(6) 2023, 44 DAYS POST STENT PLACEMENT, THE PATIENT PASSED AWAY DUE TO PROGRESSION OF PANCREATIC HEAD CANCER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 110663 | AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM | PANCREATIC STENT, COVERED, METALLIC, REMOVABLE | PCU | BOSTON SCIENTIFIC CORPORATION | M00553660 | 0030889137 | 08714729951179 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Male | Required Intervention| H |