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

Model Number M00553670

Device Problems Premature Activation (1484); Use of Device Problem (1670); Device-Device Incompatibility (2919); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/28/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2022 that an axios stent and electrocautery enhanced delivery system was to be implanted to treat a 1.5 cm to 2 cm benign stricture proximal to the pylorus during an axios stent placement procedure performed on (b)(6) 2022.During the procedure, a guidewire was used to help dilate patient's esophagus and to help position the axios stent.While advancing the axios stent over the wire, it stripped the jacket off the guidewire and the first flange of the axios stent deployed prematurely.The guidewire was removed and was replaced in an attempt to recapture the stent, but the axios stent could not be fully recaptured.The stent was removed from the patient partially deployed on the delivery system and a metal stent was successfully implanted to dilate the esophagus.The axios placement procedure was cancelled and will resume in 3 to 4 weeks, until the esophagus' lumen is wide enough to allow for a therapeutic scope to make its way down to the pylorus to place the stent.There were no patient complications reported as result of this event.Note: it was reported that the axios stent was intended to be placed for a benign pyloric stricture.However, per the hot axios stent and electrocautery- enhanced delivery system directions for use, the stent 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.The device is not indicated to be placed to treat a benign pyloric stricture.

Manufacturer Narrative

Block b5 has been updated with the additional information received on (b)(6), 2022.Block h6: medical device problem code a150103 captures the reportable event of stent first flange prematurely deployed.Evaluation conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on april 28, 2022 that an axios stent and electrocautery enhanced delivery system was to be implanted to treat a 1.5 cm to 2 cm benign stricture proximal to the pylorus during an axios stent placement procedure performed on (b)(6) 2022.During the procedure, a guidewire was used to help dilate patient's esophagus and to help position the axios stent.While advancing the axios stent over the wire, it stripped the jacket off the guidewire and the first flange of the axios stent deployed prematurely.The guidewire was removed and was replaced in an attempt to recapture the stent, but the axios stent could not be fully recaptured.The stent was removed from the patient partially deployed on the delivery system and a metal stent was successfully implanted to dilate the esophagus.The axios placement procedure was cancelled and will resume in 3 to 4 weeks, until the esophagus' lumen is wide enough to allow for a therapeutic scope to make its way down to the pylorus to place the stent.There were no patient complications reported as result of this event.Note: it was reported that the axios stent was intended to be placed for a benign pyloric stricture.However, per the hot axios stent and electrocautery- enhanced delivery system directions for use, the stent 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.The device is not indicated to be placed to treat a benign pyloric stricture.***additional information received on (b)(6), 2022*** it was reported that the guidewire was cut at the distal tip of the axios catheter using wire cutters and was then able to be pulled out from the handle end of the axios catheter.

• Brand Name: AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
• Type of Device: PANCREATIC STENT, COVERED, METALLIC, REMOVABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14459127
• MDR Text Key: 292215977
• Report Number: 3005099803-2022-02803
• Device Sequence Number: 1
• Product Code: PCU
• UDI-Device Identifier: 08714729979333
• UDI-Public: 08714729979333
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2023
• Device Model Number: M00553670
• Device Catalogue Number: 5367
• Device Lot Number: 0028142862
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Race: White