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

Model Number	M00565010
Medical Device Problem Codes	Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of stent material deformation.Imdrf device code a150101 captures the reportable event of stent failure to expand.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral duodenal stent was implanted to treat a malignant stenosis in the duodenal bulb descending conjunction during an intestinal metal stent placement procedure performed on (b)(6) 2024.The patient's anatomy was tortuous.During the procedure, the stent was deployed; however, the stent did not expand, and the tip portion of the stent was loose.The stent was removed from the patient using snares.Another wallflex enteral duodenal 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.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of stent material deformation.Imdrf device code a150101 captures the reportable event of stent failure to expand.Block h11: a wallflex duodenal stent was received for analysis.Visual inspection found stent was fully covered and undeployed.Functional examination was performed by sliding the delivery handle back along with stainless-steel tube, and the stent was deployed with no problems or resistance felt.No damages were noted to the stent and delivery system.Product analysis did not confirm the reported event of stent failure to expand and stent material deformation.The stent was returned fully covered by the outer sheath.In addition, the stent was in good shape and condition when deployed during functional examination.Taking all available information into consideration, the investigation concluded that the most probable root cause is no problem detected.Note: as the reported event was not confirmed, and no damages were noted to the device that would cause or contribute to a death or serious injury if the malfunction were to recur, boston scientific no longer considers this to be a reportable event.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral duodenal stent was implanted to treat a malignant stenosis in the duodenal bulb descending conjunction during an intestinal metal stent placement procedure performed on (b)(6) 2024.The patient's anatomy was tortuous.During the procedure, the stent was deployed; however, the stent did not expand, and the tip portion of the stent was loose.The stent was removed from the patient using snares.Another wallflex enteral duodenal 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.

• 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 ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19463895
• Report Number: 3005099803-2024-02588
• Device Sequence Number: 7907889
• Product Code: MUM
• UDI-Device Identifier: 08714729456483
• UDI-Public: 08714729456483
• 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): 07/22/2024

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: 07/02/2025
• Device Model Number: M00565010
• Device Catalogue Number: 6501
• Device Lot Number: 0031938206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2024
• Supplement Date Received by Manufacturer: 06/23/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2023
• 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: 77 YR
• Patient Sex: Female
• Patient Weight: 48 KG