MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AXIOS STENT AND DELIVERY SYSTEM; PANCREATIC STENT, COVERED, METALLIC, REMOVABLE

Model Number	AXSUS-15-10
Medical Device Problem Codes	Difficult to Remove (1528); Use of Device Problem (1670); Human-Device Interface Problem (2949); Migration (4003)
Health Effect - Clinical Codes	Abscess (1690); Fever (1858); Unspecified Infection (1930); Pain (1994)
Date of Event	08/01/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The exact date of the event is unknown.The provided event date was chosen as an estimate based on the dates provided in the literature.The specific lot number was not reported; therefore, the manufacture date and expiration date are unknown.Implant date: the stent was implanted in (b)(6) 2015.Explant date: the stent was explanted in (b)(6) 2015.(b)(4).Literature source: irani, s., & kozarek, r.A.(2016).The buried lumen-apposing metal stent: is this a stent problem, a location problem, or both? videogie, 1(1), 25-26.Doi: dx.Doi.Org/10.1016/j.Vgie.2016.07.007.The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
Boston scientific corporation became aware of an event through a literature article entitled "the buried lumen-apposing metal stent: is this a stent problem, a location problem, or both?" written by shayan irani and richard a.Kozarek.According to the article, a 10mm x 15mm axios stent was implanted in a transgastric position to treat a 5.5 cm recurrent painful septated hepatic cyst during an endoscopic ultrasound (eus) guided hepatic cystgastrostomy with lumen-apposing metal stent (lams) placement procedure performed in (b)(6) 2015.The hepatic cyst was abutting the gastric antrum, with a wall distance of less than 1 cm.The stent was noted to be in good position from the gastric antrum to the cyst, with a fully expanded flange.An additional 7f pigtail stent was placed through the lams.In (b)(6) 2015, 6 weeks post stent placement, the patient experienced nocturnal fever and pain.A ct scan showed that most of the cyst had decompressed with the exception of an undrained component behind the existing septation.Due to concern for a liver abscess, the patient underwent an endoscopic esophagogastroduodenoscopy (egd).At this time, the stent was no longer visible and only the 7f pigtail stent was seen.An endoscopic retrograde cholangiopancreatography (ercp) extraction balloon with a guidewire was used to access the liver cyst, at which point a purulent discharge emerged, confirming a liver abscess.Dilation with a 12 to 15 mm balloon allowed visualization of the buried axios stent, and the endoscope was able to be advanced into the liver abscess.Due to concern of infection of the undrained component of the cyst, a sclerotherapy needle was used to puncture the wall of the liver and contrast was injected, confirming the residual, undrained portion of the cyst.Pus emerged from this part of the cyst upon withdrawal of the needle.A straight ercp catheter was introduced and the septation was dilated with a balloon.The axios stent was grasped with rat-toothed forceps and removed with some difficulty.The endoscope was advanced into the abscess, and contrast was injected to confirm that there was no leakage between the cyst and the gastric wall.Three 7 f x 5 cm pigtail stents were placed to complete the procedure.There were no further patient complications reported as a result of this procedure.The patient was reported to be asymptomatic since the procedure.
Event or Problem Description
Boston scientific corporation became aware of an event through a literature article entitled "the buried lumen-apposing metal stent: is this a stent problem, a location problem, or both?" written by shayan irani and richard a.Kozarek (see citation in mfr narrative).According to the article, a 10mm x 15mm axios stent was implanted in a transgastric position to treat a 5.5 cm recurrent painful septated hepatic cyst during an endoscopic ultrasound (eus) guided hepatic cystgastrostomy with lumen-apposing metal stent (lams) placement procedure performed in (b)(6) 2015.The hepatic cyst was abutting the gastric antrum, with a wall distance of less than 1 cm.The stent was noted to be in good position from the gastric antrum to the cyst, with a fully expanded flange.An additional 7f pigtail stent was placed through the lams.In (b)(6) 2015, 6 weeks post stent placement, the patient experienced nocturnal fever and pain.A ct scan showed that most of the cyst had decompressed with the exception of an undrained component behind the existing septation.Due to concern for a liver abscess, the patient underwent an endoscopic esophagogastroduodenoscopy (egd).At this time, the stent was no longer visible and only the 7f pigtail stent was seen.An endoscopic retrograde cholangiopancreatography (ercp) extraction balloon with a guidewire was used to access the liver cyst, at which point a purulent discharge emerged, confirming a liver abscess.Dilation with a 12 to 15 mm balloon allowed visualization of the buried axios stent, and the endoscope was able to be advanced into the liver abscess.Due to concern of infection of the undrained component of the cyst, a sclerotherapy needle was used to puncture the wall of the liver and contrast was injected, confirming the residual, undrained portion of the cyst.Pus emerged from this part of the cyst upon withdrawal of the needle.A straight ercp catheter was introduced and the septation was dilated with a balloon.The axios stent was grasped with rat-toothed forceps and removed with some difficulty.The endoscope was advanced into the abscess, and contrast was injected to confirm that there was no leakage between the cyst and the gastric wall.Three 7 f x 5 cm pigtail stents were placed to complete the procedure.There were no further patient complications reported as a result of this procedure.The patient was reported to be asymptomatic since the procedure.Note: the hot axios stent was placed transgastric to a hepatic cyst.The hot axios stent and 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 with >= 70% fluid content that are adherent to the gastric or bowel wall.The device is not indicated for placement in the liver.
Additional Manufacturer Narrative
The exact date of the event is unknown.The provided event date was chosen as an estimate based on the dates provided in the literature.The specific lot number was not reported; therefore, the manufacture date and expiration date are unknown.The stent was implanted in (b)(6) 2015.The stent was explanted in (b)(6) 2015.Device code 2949 captures the reportable event of stent overgrowth.Device code 4003 captures the reportable event of stent migrated.Device code 1528 captures the reportable event of stent difficult to remove.Literature source: irani, s., & kozarek, r.A.(2016).The buried lumen-apposing metal stent: is this a stent problem, a location problem, or both? videogie, 1(1), 25-26.Doi: dx.Doi.Org/10.1016/j.Vgie.2016.07.007 the device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• Brand Name: AXIOS STENT AND DELIVERY SYSTEM
• Common Device Name: PANCREATIC STENT, COVERED, METALLIC, REMOVABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8011538
• Report Number: 3005099803-2018-60943
• Device Sequence Number: 11088325
• Product Code: PCU
• UDI-Device Identifier: 08714729904632
• UDI-Public: 08714729904632
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K140561
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,litera
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AXSUS-15-10
• Device Catalogue Number: 50271
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/28/2018
• Supplement Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 10/28/2018
• Supplement Report FDA Received Date: 12/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR