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BOSTON SCIENTIFIC CORPORATION AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM; PANCREATIC STENT, COVERED, METALLIC, REMOVABLE
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| Model Number M00553660 |
| Device Problems
Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
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| Patient Problems
Unspecified Infection (1930); Bowel Perforation (2668); Swelling/ Edema (4577)
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| Event Date 03/23/2023 |
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Event Type
Injury
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Event Description
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It was reported to boston scientific corporation on march 24, 2023 that an axios stent and electrocautery-enhanced delivery system was implanted transduodenal to jejunum to treat a malignant gastric outlet obstruction on (b)(6) 2023 as part of the e7127 hot axios system eus-guided double-balloon-occluded gastrojejunostomy bypass (epass) clinical study.The patient was enrolled into the clinical trial on (b)(6) 2023.During the procedure, the axios stent was misdeployed; however, the axios stent remains implanted, and the procedure was completed with this device.Post- dilation was performed, and stent patency could be visualized.On (b)(6) 2023, one day post stent placement, the patient had transverse colon perforation consequently prolonging patient's hospitalization.Laboratory tests done noted an increase in inflammatory response, while computed tomography (ct) scan of the transverse colon between the stomach and jejunum confirmed that the transverse colon was penetrated during puncture.Furthermore, the patient did not report abdominal pain; however, antibiotic therapy has been given following patient's blood culture.Fluoroscopy was performed showing an edematous mucosa of the transverse colon.Subsequently, on the same day, the perforated site was closed, transverse colostomy, gastrojejunostomy, and stent removal were performed.Note: it was reported that the axios stent and electrocautery-enhanced delivery system was implanted to treat a malignant gastric outlet obstruction.Per the instructions for use (ifu), "the axios stent and electrocautery-enhanced delivery system is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts > 6cm in size and walled-off necrosis > 6cm in size that are adherent to the gastric or bowel wall." the stent is not indicated for the treatment of malignant gastric outlet obstruction.
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Manufacturer Narrative
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Report source: e7127 hot axios system eus-guided double-balloon-occluded gastrojejunostomy bypass (epass) study.Patient code e1006 captures the reportable event of perforation, bowel.Patient code e1906 captures the reportable event of infection.Patient code e2338 captures the reportable event of edematous mucosa of the transverse colon.Impact code f08 captures the patient's prolonged hospitalization.Impact code f19 captures the surgical intervention to remove the stent.Impact code f2303 captures the administration of antibiotics.Imdrf device code a1502 captures the reportable event of stent misdeployment.
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Manufacturer Narrative
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Blocks b2, b5, and d6a have been updated with additional information received on april 17, 2023 and may 03, 2023.Block g2: report source: e7127 hot axios system eus-guided double-balloon-occluded gastrojejunostomy bypass (epass) study.Block h6: patient code e1006 captures the reportable event of perforation, bowel.Patient code e1906 captures the reportable event of infection.Patient code e2338 captures the reportable event of edematous mucosa of the transverse colon.Impact code f08 captures the patient's prolonged hospitalization.Impact code f19 captures the surgical intervention to remove the stent.Impact code f2303 captures the administration of antibiotics.Imdrf device code a1502 captures the reportable event of stent misdeployment.
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Event Description
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It was reported to boston scientific corporation on march 24, 2023 that an axios stent and electrocautery-enhanced delivery system was implanted transduodenal to jejunum to treat a malignant gastric outlet obstruction on (b)(6) 2023 as part of the e7127 hot axios system eus-guided double-balloon-occluded gastrojejunostomy bypass (epass) clinical study.The patient was enrolled into the clinical trial on march 20, 2023.During the procedure, the axios stent was misdeployed; however, the axios stent remains implanted, and the procedure was completed with this device.Post- dilation was performed, and stent patency could be visualized.On (b)(6) 2023, one day post stent placement, the patient had transverse colon perforation consequently prolonging patient's hospitalization.Laboratory tests done noted an increase in inflammatory response, while computed tomography (ct) scan of the transverse colon between the stomach and jejunum confirmed that the transverse colon was penetrated during puncture.Furthermore, the patient did not report abdominal pain; however, antibiotic therapy has been given following patient's blood culture.Fluoroscopy was performed showing an edematous mucosa of the transverse colon.Subsequently, on the same day, the perforated site was closed, transverse colostomy, gastrojejunostomy, and stent removal were performed.Note: it was reported that the axios stent and electrocautery-enhanced delivery system was implanted to treat a malignant gastric outlet obstruction.Per the instructions for use (ifu), "the axios stent and electrocautery-enhanced delivery system is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts > 6cm in size and walled-off necrosis > 6cm in size that are adherent to the gastric or bowel wall." the stent is not indicated for the treatment of malignant gastric outlet obstruction.Additional information received on may 03, 2023 the adhesions on the abdominal cavity with a lump between the stomach, transverse colon and the colon mesenteric membrane were noted to be very strong.Consequently, a colon to colon bypass was not possible and a radical stent removal or closure of the gastrocolic fistula was difficult to perform, thus a gastrojejunal bypass and colon stoma were created.However, the physician encountered difficulties while creating a bypass; thus, colostomy was performed the following day, march 24, 2023.Patient was then instructed to continue taking analgesic and actively underwent rehabilitation.On april 3, 2023, ct scan revealed no stent deviation, no air, and no wall thickening or ascites in the intestinal tract.Laboratory results had slightly improved as well.The stent was then removed on (b)(6) 2023 and the fistula was closed.The next day, no displacement was noted as well as any leakage of contrast agent into the peritoneal cavity or free air observed.
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Manufacturer Narrative
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Block b5 has been updated with additional information received on may 11, 2023 and may 17, 2023.Block g2: report source: e7127 hot axios system eus-guided double-balloon-occluded gastrojejunostomy bypass (epass) study.Block h6: patient code e1006 captures the reportable event of perforation, bowel.Patient code e1906 captures the reportable event of infection.Patient code e2338 captures the reportable event of edematous mucosa of the transverse colon.Impact code f08 captures the patient's prolonged hospitalization.Impact code f19 captures the surgical intervention to remove the stent.Impact code f2303 captures the administration of antibiotics.Imdrf device code a1502 captures the reportable event of stent misdeployment.Block h10: an axios stent was received for analysis; the electrocautery-enhanced delivery system was not returned.Visual inspection found holes on the stent cover and one of the stent wires unraveled.No other problems were noted to the stent.The reported event of stent positioning issue could not be confirmed as this occurred during the procedure.It is most likely that procedural factors such as handling of the device and the technique used by the physician when removing the stent from the patient contributed to the observed events of stent cover damaged (holes) and stent damaged.A product labeling review identified that the device was not used in accordance with the instructions for use (ifu) / product label.The complainant reported that the axios stent was implanted to treat a malignant gastric outlet obstruction.The ifu states, "the axios stent and electrocautery-enhanced delivery system is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts >= 6cm in size and walled-off necrosis >= 6cm in size that are adherent to the gastric or bowel wall." additionally, stent positioning issue, perforation, infection, and surgical intervention are noted within the ifu as potential adverse events associated with the use of the device.Therefore, a review and analysis of all available information indicated the most probable cause is known inherent risk of device.
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Event Description
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It was reported to boston scientific corporation on (b)(6) 2023 that an axios stent and electrocautery-enhanced delivery system was implanted transduodenal to jejunum to treat a malignant gastric outlet obstruction on (b)(6) 2023 as part of the e7127 hot axios system eus-guided double-balloon-occluded gastrojejunostomy bypass (epass) clinical study.The patient was enrolled into the clinical trial on (b)(6) 2023.During the procedure, the axios stent was misdeployed; however, the axios stent remains implanted, and the procedure was completed with this device.Post- dilation was performed, and stent patency could be visualized.On (b)(6) 2023, one day post stent placement, the patient had transverse colon perforation consequently prolonging patient's hospitalization.Laboratory tests done noted an increase in inflammatory response, while computed tomography (ct) scan of the transverse colon between the stomach and jejunum confirmed that the transverse colon was penetrated during puncture.Furthermore, the patient did not report abdominal pain; however, antibiotic therapy has been given following patient's blood culture.Fluoroscopy was performed showing an edematous mucosa of the transverse colon.Subsequently, on the same day, the perforated site was closed, transverse colostomy, gastrojejunostomy, and stent removal were performed.Note: it was reported that the axios stent and electrocautery-enhanced delivery system was implanted to treat a malignant gastric outlet obstruction.Per the instructions for use (ifu), "the axios stent and electrocautery-enhanced delivery system is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts > 6cm in size and walled-off necrosis > 6cm in size that are adherent to the gastric or bowel wall." the stent is not indicated for the treatment of malignant gastric outlet obstruction.**additional information received on may 03, 2023** the adhesions on the abdominal cavity with a lump between the stomach, transverse colon and the colon mesenteric membrane were noted to be very strong.Consequently, a colon to colon bypass was not possible and a radical stent removal or closure of the gastrocolic fistula was difficult to perform, thus a gastrojejunal bypass and colon stoma were created.However, the physician encountered difficulties while creating a bypass; thus, colostomy was performed the following day, (b)(6) 2023.Patient was then instructed to continue taking analgesic and actively underwent rehabilitation.On (b)(6) 2023, ct scan revealed no stent deviation, no air, and no wall thickening or ascites in the intestinal tract.Laboratory results had slightly improved as well.The stent was then removed on (b)(6) 2023 and the fistula was closed.The next day, no displacement was noted as well as any leakage of contrast agent into the peritoneal cavity or free air observed.**additional information received on may 11, 2023 and may 17, 2023** on (b)(6) 2023, the patient passed away due to progression of pancreatic cancer.
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Event Description
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It was reported to boston scientific corporation on march 24, 2023 that an axios stent and electrocautery-enhanced delivery system was implanted transduodenal to jejunum to treat a malignant gastric outlet obstruction on (b)(6) 2023 as part of the e7127 hot axios system eus-guided double-balloon-occluded gastrojejunostomy bypass (epass) clinical study.The patient was enrolled into the clinical trial on (b)(6) 2023.During the procedure, the axios stent was misdeployed; however, the axios stent remains implanted, and the procedure was completed with this device.Post- dilation was performed, and stent patency could be visualized.On (b)(6) 2023, one day post stent placement, the patient had transverse colon perforation consequently prolonging patient's hospitalization.Laboratory tests done noted an increase in inflammatory response, while computed tomography (ct) scan of the transverse colon between the stomach and jejunum confirmed that the transverse colon was penetrated during puncture.Furthermore, the patient did not report abdominal pain; however, antibiotic therapy has been given following patient's blood culture.Fluoroscopy was performed showing an edematous mucosa of the transverse colon.Subsequently, on the same day, the perforated site was closed, transverse colostomy, gastrojejunostomy, and stent removal were performed.Note: it was reported that the axios stent and electrocautery-enhanced delivery system was implanted to treat a malignant gastric outlet obstruction.Per the instructions for use (ifu), "the axios stent and electrocautery-enhanced delivery system is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts > 6cm in size and walled-off necrosis > 6cm in size that are adherent to the gastric or bowel wall." the stent is not indicated for the treatment of malignant gastric outlet obstruction.**additional information received on may 03, 2023** the adhesions on the abdominal cavity with a lump between the stomach, transverse colon and the colon mesenteric membrane were noted to be very strong.Consequently, a colon to colon bypass was not possible and a radical stent removal or closure of the gastrocolic fistula was difficult to perform, thus a gastrojejunal bypass and colon stoma were created.However, the physician encountered difficulties while creating a bypass; thus, colostomy was performed the following day, (b)(6) 2023.Patient was then instructed to continue taking analgesic and actively underwent rehabilitation.On (b)(6) 2023, ct scan revealed no stent deviation, no air, and no wall thickening or ascites in the intestinal tract.Laboratory results had slightly improved as well.The stent was then removed on (b)(6) 2023 and the fistula was closed.The next day, no displacement was noted as well as any leakage of contrast agent into the peritoneal cavity or free air observed.**additional information received on may 11, 2023 and may 17, 2023** on april 26, 2023, the patient passed away due to progression of pancreatic cancer.**additional information received on june 12, 2023** during the procedure, stent placement was confirmed without any problems.On (b)(6) 2023, the patient was discharged and recommended to be on palliative care.
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Manufacturer Narrative
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Block g2: report source: e7127 hot axios system eus-guided double-balloon-occluded gastrojejunostomy bypass (epass) study.Block h6: patient code e1006 captures the reportable event of perforation, bowel.Patient code e1906 captures the reportable event of infection.Patient code e2338 captures the reportable event of edematous mucosa of the transverse colon.Impact code f08 captures the patient's prolonged hospitalization.Impact code f2303 captures the administration of antibiotics.An axios stent was received for analysis; the electrocautery-enhanced delivery system was not returned.Visual inspection found holes on the stent cover and one of the stent wires unraveled.No other problems were noted to the stent.The reported event of stent positioning issue could not be confirmed as this occurred during the procedure.It is most likely that procedural factors such as handling of the device and the technique used by the physician when removing the stent from the patient contributed to the observed events of stent cover damaged (holes) and stent damaged.A product labeling review identified that the device was not used in accordance with the instructions for use (ifu) / product label.The complainant reported that the axios stent was implanted to treat a malignant gastric outlet obstruction.The ifu states, "the axios stent and electrocautery-enhanced delivery system is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts >= 6cm in size and walled-off necrosis >= 6cm in size that are adherent to the gastric or bowel wall." additionally, stent positioning issue, perforation, infection, and surgical intervention are noted within the ifu as potential adverse events associated with the use of the device.Therefore, a review and analysis of all available information indicated the most probable cause is known inherent risk of device.
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| |
|
Event Description
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|
It was reported to boston scientific corporation on march 24, 2023 that an axios stent and electrocautery-enhanced delivery system was implanted transduodenal to jejunum to treat a malignant gastric outlet obstruction on (b)(6) 2023 as part of the e7127 hot axios system eus-guided double-balloon-occluded gastrojejunostomy bypass (epass) clinical study.The patient was enrolled into the clinical trial on (b)(6) 2023.During the procedure, the axios stent was misdeployed; however, the axios stent remains implanted, and the procedure was completed with this device.Post- dilation was performed, and stent patency could be visualized.On (b)(6) 2023, one day post stent placement, the patient had transverse colon perforation consequently prolonging patient's hospitalization.Laboratory tests done noted an increase in inflammatory response, while computed tomography (ct) scan of the transverse colon between the stomach and jejunum confirmed that the transverse colon was penetrated during puncture.Furthermore, the patient did not report abdominal pain; however, antibiotic therapy has been given following patient's blood culture.Fluoroscopy was performed showing an edematous mucosa of the transverse colon.Subsequently, on the same day, the perforated site was closed, transverse colostomy, gastrojejunostomy, and stent removal were performed.Note: it was reported that the axios stent and electrocautery-enhanced delivery system was implanted to treat a malignant gastric outlet obstruction.Per the instructions for use (ifu), "the axios stent and electrocautery-enhanced delivery system is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts > 6cm in size and walled-off necrosis > 6cm in size that are adherent to the gastric or bowel wall." the stent is not indicated for the treatment of malignant gastric outlet obstruction.**additional information received on may 03, 2023** the adhesions on the abdominal cavity with a lump between the stomach, transverse colon and the colon mesenteric membrane were noted to be very strong.Consequently, a colon to colon bypass was not possible and a radical stent removal or closure of the gastrocolic fistula was difficult to perform, thus a gastrojejunal bypass and colon stoma were created.However, the physician encountered difficulties while creating a bypass; thus, colostomy was performed the following day, (b)(6) 2023.Patient was then instructed to continue taking analgesic and actively underwent rehabilitation.On (b)(6) 2023, ct scan revealed no stent deviation, no air, and no wall thickening or ascites in the intestinal tract.Laboratory results had slightly improved as well.The stent was then removed on (b)(6) 2023 and the fistula was closed.The next day, no displacement was noted as well as any leakage of contrast agent into the peritoneal cavity or free air observed.**additional information received on may 11, 2023 and may 17, 2023** on april 26, 2023, the patient passed away due to progression of pancreatic cancer.**additional information received on june 12, 2023** during the procedure, stent placement was confirmed without any problems.On (b)(6) 2023, the patient was discharged and recommended to be on palliative care.
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Manufacturer Narrative
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Block g2: report source: e7127 hot axios system eus-guided double-balloon-occluded gastrojejunostomy bypass (epass) study.Block h6: patient code e1006 captures the reportable event of perforation, bowel.Patient code e1906 captures the reportable event of infection.Patient code e2338 captures the reportable event of edematous mucosa of the transverse colon.Impact code f08 captures the patient's prolonged hospitalization.Impact code f2303 captures the administration of antibiotics.An axios stent was received for analysis; the electrocautery-enhanced delivery system was not returned.Visual inspection found holes on the stent cover and one of the stent wires unraveled.No other problems were noted to the stent.The damages noted to the stent were most likely due to procedural factors encountered during the procedure.It may be the handling of the device and the technique used by the physician when removing the stent from the patient contributed to stent cover damaged (holes) and stent wire unraveled.A product labeling review identified that the device was not used in accordance with the instructions for use (ifu) / product label.The complainant reported that the axios stent was implanted to treat a malignant gastric outlet obstruction.The ifu states, "the axios stent and electrocautery-enhanced delivery system is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts >= 6cm in size and walled-off necrosis >= 6cm in size that are adherent to the gastric or bowel wall." additionally, perforation, infection, and surgical intervention are noted within the ifu as potential adverse events associated with the use of the device.Therefore, a review and analysis of all available information indicated the most probable cause is known inherent risk of device.
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Manufacturer Narrative
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Block g2: report source: e7127 hot axios system eus-guided double-balloon-occluded gastrojejunostomy bypass (epass) study.Block h6: patient code e1006 captures the reportable event of perforation, bowel.Patient code e1906 captures the reportable event of infection.Patient code e2338 captures the reportable event of edematous mucosa of the transverse colon.Impact code f08 captures the patient's prolonged hospitalization.Impact code f2303 captures the administration of antibiotics.Block h10: an axios stent was received for analysis; the electrocautery-enhanced delivery system was not returned.Visual inspection found holes on the stent cover and one of the stent wires unraveled.No other problems were noted to the stent.The damages noted to the stent were most likely due to procedural factors encountered during the procedure.It may be the handling of the device and the technique used by the physician when removing the stent from the patient contributed to stent cover damaged (holes) and stent wire unraveled.A labeling review was performed and, from the information available, there is no information that this device was used in a manner inconsistent with the instructions for use (ifu)/product label.Additionally, perforation, infection, and surgical intervention are noted within the ifu as potential adverse events associated with the use of the device.Therefore, a review and analysis of all available information indicated the most probable cause is known inherent risk of device.Block h11: blocks b5, h6 (device codes and evaluation result codes), and h10 have been corrected.
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Event Description
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It was reported to boston scientific corporation on (b)(6) 2023 that an axios stent and electrocautery-enhanced delivery system was implanted transduodenal to jejunum to treat a malignant gastric outlet obstruction on (b)(6) 2023 as part of the e7127 hot axios system eus-guided double-balloon-occluded gastrojejunostomy bypass (epass) clinical study.The patient was enrolled into the clinical trial on (b)(6) 2023.During the procedure, the axios stent was misdeployed; however, the axios stent remains implanted, and the procedure was completed with this device.Post- dilation was performed, and stent patency could be visualized.On (b)(6) 2023, one day post stent placement, the patient had transverse colon perforation consequently prolonging patient's hospitalization.Laboratory tests done noted an increase in inflammatory response, while computed tomography (ct) scan of the transverse colon between the stomach and jejunum confirmed that the transverse colon was penetrated during puncture.Furthermore, the patient did not report abdominal pain; however, antibiotic therapy has been given following patient's blood culture.Fluoroscopy was performed showing an edematous mucosa of the transverse colon.Subsequently, on the same day, the perforated site was closed, transverse colostomy, gastrojejunostomy, and stent removal were performed.Additional information received on may 03, 2023: the adhesions on the abdominal cavity with a lump between the stomach, transverse colon and the colon mesenteric membrane were noted to be very strong.Consequently, a colon to colon bypass was not possible and a radical stent removal or closure of the gastrocolic fistula was difficult to perform, thus a gastrojejunal bypass and colon stoma were created.However, the physician encountered difficulties while creating a bypass; thus, colostomy was performed the following day, (b)(6) 2023.Patient was then instructed to continue taking analgesic and actively underwent rehabilitation.On (b)(6) 2023, ct scan revealed no stent deviation, no air, and no wall thickening or ascites in the intestinal tract.Laboratory results had slightly improved as well.The stent was then removed on (b)(6) 2023 and the fistula was closed.The next day, no displacement was noted as well as any leakage of contrast agent into the peritoneal cavity or free air observed.Additional information received on may 11, 2023 and may 17, 2023: on (b)(6) 2023, the patient passed away due to progression of pancreatic cancer.Additional information received on june 12, 2023: during the procedure, stent placement was confirmed without any problems.On (b)(6) 2023, the patient was discharged and recommended to be on palliative care.
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