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

Model Number	M00565030
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand.Impact code f08 is being used to capture the prolonged hospitalization of the patient.Impact code f2202 is being used to capture the dilation procedure performed.
Event or Problem Description
It was reported to boston scientific corporation on may 29, 2023, that a wallflex enteral duodenal stent was implanted in the pylorus and duodenum to treat a 4 cm malignant duodenal stricture during a duodenal stenting procedure performed on (b)(6) 2023.The patient's anatomy was tight and was dilated prior to stent placement.During the procedure, a wallflex duondenal stent was able to be deployed.However, it was noted that there was no radial expansion at the stricture site.The patient was observed for 48 hours, but there was still no radial expansion of the stent.On (b)(6) 2023, cre dilation of the stent was performed.The physician is comfortable leaving the stent implanted and the physician is planning to place another stent at the same stricture site.There were no patient complications reported as a result of this event, and the patient was expected to fully recover.

• 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: 17137812
• Report Number: 3005099803-2023-03235
• Device Sequence Number: 5972071
• Product Code: MUM
• UDI-Device Identifier: 08714729456506
• UDI-Public: 08714729456506
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K062750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/15/2023

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: 09/25/2024
• Device Model Number: M00565030
• Device Catalogue Number: 6503
• Device Lot Number: 0030215535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2023
• Initial Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 45 KG
• Patient Race: Asian