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	Fever (1858); Inflammation (1932)
Date of Event	06/15/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The specific lot number was not reported; therefore, the manufacture date and expiration date are unknown.(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, in (b)(6) 2014, the patient developed cholecystitis manifested by pericholecystic fluid.On (b)(6) 2014, a 10mm x 15mm axios stent was implanted in a transgastric position in the gallbladder during an endoscopic ultrasound (eus) gallbladder drainage with lumen-apposing metal stent (lams) placement procedure.The wall distance to the cyst was less than 1 cm.The stent was noted to be in good position from the gastric antrum to the gallbladder once deployed, and the flange was noted to be fully expanded.On (b)(6) 2015, the patient developed a fever and was observed to have recurrent cholecystitis/cholangitis.An ercp was performed, during which the stent could not be seen endoscopically, but was visible on fluoroscopy.The stent was found to be completely buried with only a small area of heaped up granulation.The stent was cannulated and a 7f x 5cm pigtail stent was placed through the stent.On (b)(6) 2015, the patient developed another fever and was determined to have recurrent cholecystitis/cholangitis.Contrast injection demonstrated that the stent had completely migrated into the gallbladder.The cystic duct was patent.Balloon dilation of the tract to the gallbladder was performed, and the endoscope was advanced into the gallbladder to remove the migrated stent.A stone rind had formed around the stent, causing difficulty in grasping the stent with rat-toothed forceps.This stone cast was broken by grasping the stent with a snare, squeezing, and forcefully pulling the stent against the tip of the endoscope.Once the stone was broken, the stent was successfully removed, and the stones were removed from the gallbladder using a roth net.The procedure was completed using two 7f pigtail stents in place of the removed axios stent.There were no further patient complications reported as a result of this procedure.The patient was discharged post procedure and reported to be doing well.
Additional Manufacturer Narrative
The specific lot number was not reported; therefore, the manufacture date and expiration date are unknown.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 (see citation in block h10).According to the article, in december 2014, the patient developed cholecystitis manifested by pericholecystic fluid.On december 10, 2014, a 10mm x 15mm axios stent was implanted in a transgastric position in the gallbladder during an endoscopic ultrasound (eus) gallbladder drainage with lumen-apposing metal stent (lams) placement procedure.The wall distance to the cyst was less than 1 cm.The stent was noted to be in good position from the gastric antrum to the gallbladder once deployed, and the flange was noted to be fully expanded.On (b)(6) 2015 the patient developed a fever and was observed to have recurrent cholecystitis/cholangitis.An ercp was performed, during which the stent could not be seen endoscopically, but was visible on fluoroscopy.The stent was found to be completely buried with only a small area of heaped up granulation.The stent was cannulated and a 7f x 5cm pigtail stent was placed through the stent.On (b)(6) 2015 the patient developed another fever and was determined to have recurrent cholecystitis/cholangitis.Contrast injection demonstrated that the stent had completely migrated into the gallbladder.The cystic duct was patent.Balloon dilation of the tract to the gallbladder was performed, and the endoscope was advanced into the gallbladder to remove the migrated stent.A stone rind had formed around the stent, causing difficulty in grasping the stent with rat-toothed forceps.This stone cast was broken by grasping the stent with a snare, squeezing, and forcefully pulling the stent against the tip of the endoscope.Once the stone was broken, the stent was successfully removed, and the stones were removed from the gallbladder using a roth net.The procedure was completed using two 7f pigtail stents in place of the removed axios stent.There were no further patient complications reported as a result of this procedure.The patient was discharged post procedure and reported to be doing well.Note: the hot axios stent was placed transgastric to the gallbladder.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 gallbladder.

• 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: 8011030
• Report Number: 3005099803-2018-60942
• Device Sequence Number: 13494093
• 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
• Device Implanted Year: 2014
• Device Explanted Year: 2015
• 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: 10/26/2018
• 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: 58 YR