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

Model Number	M00565030
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022 that a wallflex enteral stent was to be implanted to treat a malignant gastric outlet obstruction in the duodenum during a duodenal stent placement procedure performed on (b)(6) 2022.The patient's anatomy was not tortuous.During the procedure, the wallflex enteral stent could not be deployed as the steel rod became twisted.The stent was removed fully covered by the outer sheath and the procedure was not completed due to device availability.There were no patient complications due to this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
(b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the device analysis, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022 that a wallflex enteral stent was to be implanted to treat a malignant gastric outlet obstruction in the duodenum during a duodenal stent placement procedure performed on (b)(6) 2022.The patient's anatomy was not tortuous.During the procedure, the wallflex enteral stent could not be deployed as the steel rod became twisted.The stent was removed fully covered by the outer sheath and the procedure was not completed due to device availability.There were no patient complications due to this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: initial reporter address:(b)(6).Block h6: impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: a wallflex enteral duodenal stent and delivery system were returned for analysis.The stent was returned fully covered by the outer sheath and undeployed.Visual examination of the returned device found the outer blue sheath kinked in different sections.The stainless steel (handle) was kinked and separated.No other problems were noted to the stent and delivery system.The reported event of handle break was confirmed; the stainless steel handle was separated.The reported event of stent failure to deploy was confirmed; due to the condition of the returned device (handle kinked and separated), the stent could not be deployed during device analysis.The reported events and observed failures were likely due to factors encountered during the procedure.It may be that the characteristics of the lesion, how the device was handled, and/or the technique used by the user, limited the performance of the device.Therefore, contributing to the kinks noted on the outer sheath and the stainless steel handle and separation/ detachment of the stainless steel handle and resulted to inability to deploy the stent.Based on the available information, the investigation concluded that the reported events and observed failures were likely due to factors encountered during the procedure.Therefore ,the most probable cause is based on the available information is adverse event related to procedure.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• 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: 15005223
• Report Number: 3005099803-2022-03685
• Device Sequence Number: 14057053
• 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
• 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): 09/13/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2024
• Device Model Number: M00565030
• Device Catalogue Number: 6503
• Device Lot Number: 0029126315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2022
• Supplement Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2022
• 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
• Patient Sex: Unknown