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

Model Number M00553550

Device Problems Break (1069); Difficult to Remove (1528); Use of Device Problem (1670); Human-Device Interface Problem (2949)

Patient Problems Abdominal Pain (1685); Constipation (3274)

Event Date 07/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complainant indicated that the stent remains implanted; 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 Description

It was reported to boston scientific corporation on july 05, 2021 that a hot axios stent was implanted transgastric to the jejunum during a gastrojejunostomy procedure performed on (b)(6) 2020.On (b)(6) 2020, the patient experienced abdominal pain and constipation as food was unable to pass the stent.The physician checked the stent placement and it was noted that there was overgrowth and the stent shaft was torn.The stent was attempted to be removed using forceps; however, removal was unsuccessful.The physician placed another axios stent-in-stent inside the original stent and the procedure was completed.The patient's condition was reported to be fully recovered.Note: it was reported that the axios stent was placed for a gastrojejunostomy.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 pancreatic pseudocyst or a walled-off necrosis with >= 70% fluid content, gallbladder in patients with acute cholecystitis who are at high risk or unsuitable for surgery and bile duct after failed ercp in patients with biliary obstruction due to a malignant stricture.The device is not indicated for placement transgastric to the jejunum.

• Brand Name: AXIOS STENT AND 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: 12231486
• MDR Text Key: 263860280
• Report Number: 3005099803-2021-03717
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K150692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2022
• Device Model Number: M00553550
• Device Catalogue Number: 5355
• Device Lot Number: 0025068781
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2020
• 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 Outcome(s): Required Intervention