MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX DUODENAL; STENT,METALLIC,EXPANDABLE,DUODENAL

Model Number M00565020

Device Problems Difficult to Remove (1528); Positioning Problem (3009)

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

Event Date 01/23/2024

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a wallflex enteral duodenal stent was implanted to treat a 5cm malignant duodenal neoplasms during a stent implantation procedure performed on (b)(6) 2024.The patient's anatomy was tortuous.During the procedure, the stent was attempted to be deployed; however, it could not be deployed.The physician adjusted the delivery system and made another attempt to deploy the stent, but the stent suddenly fell off at the junction of rectum and sigmoid colon.The stent was unable to be removed and the physician is comfortable leaving the stent in place.Another wallflex enteral stent was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.Initial reporter facility name: the second affiliated hospital of army medical university of chinese people's liberation army block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf device code (b)(4) captures the reportable event of stent difficult to remove.

• Brand Name: WALLFLEX DUODENAL
• Type of Device: STENT,METALLIC,EXPANDABLE,DUODENAL
• 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: 18697172
• MDR Text Key: 335265553
• Report Number: 3005099803-2024-00429
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K062750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00565020
• Device Catalogue Number: 6502
• Device Lot Number: 0030901412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2023
• 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