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

Model Number	M00553750
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an axios stent was to be implanted transmurally from the distal esophagus to the stomach during an axios placement procedure performed on (b)(6) 2018.Reportedly, the stent was being placed to bridge an anastomotic stricture at the gastroesophageal (ge) junction.According to the complainant, during the procedure, the first flange was successfully deployed.However, after deployment, the first flange was visualized endoscopically and it was noted that the stent appeared to be twisted as it went into the catheter.The physician decided to discontinue placement of this stent, and the stent was then fully deployed in the patient's esophagus for retrieval.Reportedly, the second flange was difficult to deploy, and could only be deployed after unlocking both the catheter and stent locks and jiggling the delivery system's handle.The fully deployed stent was retrieved from the patient's esophagus with forceps.An examination of the stent after deployment noted that the it was not twisted.The stent appeared to be undamaged.The procedure was completed with another axios stent and delivery system.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.Note: the hot axios stent was being implanted to bridge an anastomotic stricture at the gastroesophageal (ge) junction; however, within the us, the hot axios stent and delivery system is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts = 6 cm in size and walled-off necrosis = 6 cm in size with = 70% fluid content that are adherent to the gastric or bowel wall.
Additional Manufacturer Narrative
Block has been updated with the corrected physician's name, which was received on april 24, 2018.
Event or Problem Description
It was reported to boston scientific corporation that an axios stent was to be implanted transmurally from the distal esophagus to the stomach during an axios placement procedure performed on (b)(6) 2018.Reportedly, the stent was being placed to bridge an anastomotic stricture at the gastroesophageal (ge) junction.According to the complainant, during the procedure, the first flange was successfully deployed.However, after deployment, the first flange was visualized endoscopically and it was noted that the stent appeared to be twisted as it went into the catheter.The physician decided to discontinue placement of this stent, and the stent was then fully deployed in the patient's esophagus for retrieval.Reportedly, the second flange was difficult to deploy, and could only be deployed after unlocking both the catheter and stent locks and jiggling the delivery system's handle.The fully deployed stent was retrieved from the patient's esophagus with forceps.An examination of the stent after deployment noted that the it was not twisted.The stent appeared to be undamaged.The procedure was completed with another axios stent and delivery system.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.Note: the hot axios stent was being implanted to bridge an anastomotic stricture at the gastroesophageal (ge) junction; however, within the us, 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.
Event or Problem Description
It was reported to boston scientific corporation that an axios stent was to be implanted transmurally from the distal esophagus to the stomach during an axios placement procedure performed on (b)(6) 2018.Reportedly, the stent was being placed to bridge an anastomotic stricture at the gastroesophageal (ge) junction.According to the complainant, during the procedure, the first flange was successfully deployed.However, after deployment, the first flange was visualized endoscopically and it was noted that the stent appeared to be twisted as it went into the catheter.The physician decided to discontinue placement of this stent, and the stent was then fully deployed in the patient's esophagus for retrieval.Reportedly, the second flange was difficult to deploy, and could only be deployed after unlocking both the catheter and stent locks and jiggling the delivery system's handle.The fully deployed stent was retrieved from the patient's esophagus with forceps.An examination of the stent after deployment noted that the it was not twisted.The stent appeared to be undamaged.The procedure was completed with another axios stent and delivery system.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.Note: the hot axios stent was being implanted to bridge an anastomotic stricture at the gastroesophageal (ge) junction; however, within the us, 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.
Additional Manufacturer Narrative
Investigation results: a cold axios stent and delivery system was returned for analysis.A visual examination of the device noted that the stent was received deployed with no visible damage or issues.There was no visible damage to the handle.The stent deployment hub was returned in step #2, the catheter lock was locked in position, and the yellow safety clip was not returned.A kink was noted near the luer connection.There was no damage to the tip.A functional evaluation was performed, and the catheter control hub was able to advance and retract the catheter with no resistance.The stent deployment hub also moved with no resistance.The observed damage to the catheter (sheath kinked) is consistent with excessive force being applied to the device.However, this device was used in a manner inconsistent with labeled instruction.The axios stent was being implanted to bridge an anastomotic stricture at the gastroesophageal (ge) junction; according to the axios directions for use (dfu), the 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 use in the gastroesophageal (ge) junction.Taking into consideration the evaluation conducted at the cis and the details of the complaint, the most probable cause classification is user / use error.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications.A search of the complaint database revealed that no similar complaints exist for the specified batch.

• Brand Name: AXIOS STENT AND DELIVERY SYSTEM
• Common Device Name: PANCREATIC STENT, COVERED, METALLIC, REMOVABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7324839
• Report Number: 3005099803-2018-00578
• Device Sequence Number: 120399
• Product Code: PCU
• UDI-Device Identifier: 08714729904632
• UDI-Public: 08714729904632
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/12/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/14/2019
• Device Model Number: M00553750
• Device Lot Number: 21383585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Initial Date Received by Manufacturer: 02/12/2018
• Supplement Date Received by Manufacturer: 03/28/2018; 04/24/2018
• Initial Report FDA Received Date: 03/08/2018
• Supplement Report FDA Received Date: 04/18/2018; 04/26/2018
• 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