MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX DUODENAL SOFT STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEM; STENT,METALLIC,EXPANDABLE,DUODENAL

Model Number M00555860

Device Problem Migration (4003)

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

Event Date 03/17/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a010402 captures the reportable event of stent migration.

Event Description

It was reported to boston scientific corporation on (b)(6)2023 that a wallfex duodenal uncovered stent was implanted to treat a gastroduodenal stricture during a stent placement procedure performed on (b)(6)2023.On (b)(6) 2023, post stent placement, it was noted that the stent had migrated.There are no known patient complications due to this event.Note: boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: WALLFLEX DUODENAL SOFT STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEM
• 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: 17410800
• MDR Text Key: 320037383
• Report Number: 3005099803-2023-04039
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 08714729902492
• UDI-Public: 08714729902492
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K200257
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00555860
• Device Catalogue Number: 5586
• Device Lot Number: 0031045304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2023
• Initial Date FDA Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1