AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
Report
- Report Number
- 3005099803-2023-04067
- Event Type
- Injury
- Date Received
- July 31, 2023
- Date of Event
- February 1, 2023
- Report Date
- August 28, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- PCU
- 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 B3: APPROXIMATED BASED ON THE DATE THE ARTICLE WAS PUBLISHED. BLOCK G2: LITERATURE SOURCE: NAKAHARA. K. ET AL.SELF-ASSEMBLING PEPTIDE GEL APPLICATION TO ACHIEVE ENDOSCOPIC HEMOSTASIS FOR FISTULA BLEEDING AFTER LUMEN APPOSING METAL STENT REMOVAL. JAPAN GASTROENTEROLOGICAL ENDOSCOPY SOCIETY (2023)35:E48 E49. BLOCK H10: THE AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS NOT RECEIVED FOR ANALYSIS. HOWEVER, A MEDIA ANALYSIS WAS PERFORMED, WHICH IDENTIFIED THE STENT INSIDE THE PATIENTS ANATOMY. THE COMPUTED TOMOGRAPHY IMAGES IDENTIFIED THE FISTULA, THE TISSUE OVERGROWTH/INGROWTH WITH HEMORRHAGE. MEDIA ANALYSIS CONFIRMED THE REPORTED FISTULA, HEMORRHAGE, AND STENT OBSTRUCTION WITHIN DEVICE. ADDITIONALLY, THESE EVENTS ARE A KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE USE OF THIS DEVICE IN THE MANUFACTURERS LABELING. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS KNOWN INHERENT RISK OF DEVICE. A PRODUCT LABELING REVIEW IDENTIFIED THAT THE DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU) / PRODUCT LABEL. BLOCK H6: PATIENT CODE E0506 HEMORRHAGE/BLOOD LOSS/BLEEDING CAPTURES THE ACTIVE BLEEDING FROM THE FISTULA. PATIENT CODE E2314 FISTULA CAPTURES THE REPORTED FISTULA. IMPACT CODE F23 UNEXPECTED MEDICAL INTERVENTION CAPTURES PROCEDURE REQUIRED TO REMOVE THE AXIOS STENT. IMPACT CODE F2301 ADDITIONAL DEVICE REQUIRED CAPTURES THE SNARE AND FORCEPS USED. IMPACT CODE F08 HOSPITALIZATION OR PROLONGED HOSPITALIZATION CAPTURES THE PATIENTS ADMISSION TO THE HOSPITAL. DEVICE CODE A0106 DEVICE STENOSIS CAPTURE THE POLYP INGROWTH INTO THE AXIOS STENT. BLOCK H6 IMPACT CODE HAS BEEN UPDATED TO INCLUDE HOSPITALIZATION OR PROLONGED HOSPITALIZATION.
BLOCK B3: APPROXIMATED BASED ON THE DATE THE ARTICLE WAS PUBLISHED. BLOCK G2: LITERATURE SOURCE: NAKAHARA. K. ET AL.SELF-ASSEMBLING PEPTIDE GEL APPLICATION TO ACHIEVE ENDOSCOPIC HEMOSTASIS FOR FISTULA BLEEDING AFTER LUMEN APPOSING METAL STENT REMOVAL. JAPAN GASTROENTEROLOGICAL ENDOSCOPY SOCIETY (2023)35:E48 E49.
BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM THROUGH THE ARTICLE SELF-ASSEMBLING PEPTIDE GEL APPLICATION TO ACHIEVE ENDOSCOPIC HEMOSTASIS FOR FISTULA BLEEDING AFTER LUMEN APPOSING METAL STENT REMOVAL. ACCORDING TO THE LITERATURE, A 20X10MM AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS IMPLANTED DURING AN ENDOSCOPIC ULTRASOUND-GUIDED CYSTOGASTROSTOMY FOR TREATMENT OF A REFRACTORY INFECTED PANCREATIC PSEUDOCYST. IT WAS REPORTED THAT 2 MONTHS POST STENT PLACEMENT THE PATIENT WAS ADMITTED FOR REMOVAL OF THE PREVIOUSLY IMPLANTED AXIOS STENT. ON ADMISSION, AN ENHANCED COMPUTED TOMOGRAPHY SHOWED IMPROVEMENT OF THE PANCREATIC CYST AND NO HEMORRHAGIC LESIONS. A SIDE-VIEWING ENDOSCOPE REVEALED A GRANULATION POLYP INGROWTH INTO THE AXIOS STENT IN THE STOMACH. THE POLYP WAS RESECTED USING A POLYPECTOMY SNARE. SUBSEQUENTLY, THE AXIOS STENT WAS REMOVED USING GRASPING FORCEPS AND ACTIVE BLEEDING FROM THE FISTULA OCCURRED. THE ENDOSCOPE WAS EXCHANGED FOR AN UPPER FORWARD VIEWING SCOPE TO ACHIEVE HEMOSTASIS. THE FISTULA HAD GRADUALLY NARROWED, AND THE BLEEDING POINT COULD NOT BE CLEARLY IDENTIFIED. THEREFORE, A 3ML OF PURASTAT WAS APPLIED TO THE SUSPECTED BLEEDING SITE AND HEMOSTASIS WAS ACHIEVED. THE PATIENT WAS DISCHARGED AFTER 4 DAYS WITHOUT ANY EVIDENCE OF RECURRENT BLEEDING.
BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM THROUGH THE ARTICLE SELF-ASSEMBLING PEPTIDE GEL APPLICATION TO ACHIEVE ENDOSCOPIC HEMOSTASIS FOR FISTULA BLEEDING AFTER LUMEN APPOSING METAL STENT REMOVAL. ACCORDING TO THE LITERATURE, A 20X10MM AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS IMPLANTED DURING AN ENDOSCOPIC ULTRASOUND-GUIDED CYSTOGASTROSTOMY FOR TREATMENT OF A REFRACTORY INFECTED PANCREATIC PSEUDOCYST. IT WAS REPORTED THAT 2 MONTHS POST STENT PLACEMENT THE PATIENT WAS ADMITTED FOR REMOVAL OF THE PREVIOUSLY IMPLANTED AXIOS STENT. ON ADMISSION, AN ENHANCED COMPUTED TOMOGRAPHY SHOWED IMPROVEMENT OF THE PANCREATIC CYST AND NO HEMORRHAGIC LESIONS. A SIDE-VIEWING ENDOSCOPE REVEALED A GRANULATION POLYP INGROWTH INTO THE AXIOS STENT IN THE STOMACH. THE POLYP WAS RESECTED USING A POLYPECTOMY SNARE. SUBSEQUENTLY, THE AXIOS STENT WAS REMOVED USING GRASPING FORCEPS AND ACTIVE BLEEDING FROM THE FISTULA OCCURRED. THE ENDOSCOPE WAS EXCHANGED FOR AN UPPER FORWARD VIEWING SCOPE TO ACHIEVE HEMOSTASIS. THE FISTULA HAD GRADUALLY NARROWED, AND THE BLEEDING POINT COULD NOT BE CLEARLY IDENTIFIED. THEREFORE, A 3ML OF PURASTAT WAS APPLIED TO THE SUSPECTED BLEEDING SITE AND HEMOSTASIS WAS ACHIEVED. THE PATIENT WAS DISCHARGED AFTER 4 DAYS WITHOUT ANY EVIDENCE OF RECURRENT BLEEDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1812920 | AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM | PANCREATIC STENT, COVERED, METALLIC, REMOVABLE | PCU | BOSTON SCIENTIFIC CORPORATION | 5356 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Female | Required Intervention |