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

Model Number	M00565030
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral duodenal stent was to be implanted in the duodenum to treat a malignant 8-cm duodenal ileus during a duodenal stent implantation procedure performed on (b)(6) 2024.The patient's anatomy was tortuous.During the procedure, the stent was deployed in an incorrect location.The stent was attempted to be removed using an additional device, but it could not be removed.The stent remains implanted, but a new procedure was scheduled to remove the stent.There were no patient complications reported as a result of this event, and the patient's condition after the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a1502 captures the reportable event of a stent's positioning issue.
Additional Manufacturer Narrative
Block h6: imdrf device code a1502 captures the reportable event of a stent's positioning issue.Block h11: a wallflex enteral duodenal stent and delivery system was received for analysis.The stent was not returned, only the delivery system.The analysis of the returned device did not identify any evidence of the reported event.No problems were noted with the delivery system.The reported event of stent positioning issue was not confirmed.The stent was not returned, and the analysis of the delivery system did not identify any problems or damages.Taking all available information into consideration, the overall root cause of the reported event is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral duodenal stent was to be implanted in the duodenum to treat a malignant 8-cm duodenal ileus during a duodenal stent implantation procedure performed on (b)(6) 2024.The patient's anatomy was tortuous.During the procedure, the stent was deployed in an incorrect location.The stent was attempted to be removed using an additional device, but it could not be removed.The stent remains implanted, but a new procedure was scheduled to remove the stent.There were no patient complications reported as a result of this event, and the patient condition after the procedure was reported to be stable.

• Brand Name: WALLFLEX DUODENAL
• Common Device Name: 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
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19250324
• Report Number: 3005099803-2024-02079
• Device Sequence Number: 17975149
• Product Code: MUM
• UDI-Device Identifier: 08714729456506
• UDI-Public: 08714729456506
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K062750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/25/2025
• Device Model Number: M00565030
• Device Catalogue Number: 6503
• Device Lot Number: 0031890715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 68 KG