MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX COLONIC; STENT, COLONIC, METALIC, EXPANDABLE

Model Number	M00565050
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral colonic stent was used to treat a malignant intestinal obstruction during a stent placement procedure performed on (b)(6) 2023.The location of the lesion blocked the intestinal cavity and is highly edematous.During the procedure, the stent was partially deployed; however, the patient's pain worsened.Consequently, the procedure was stopped, and the stent was removed partially deployed on the delivery system.The procedure was not completed due to the same device not being available.The patient's condition at the conclusion of the procedure was reported to be stable.In the physician's assessment, the pain was caused by the intestinal obstruction and there was no relationship with the wallflex enteral stent.The pain was resolved by gastrointestinal decompression and cleansing enema.
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.Block h10: a wallflex enteral colonic stent and delivery system were received for analysis.The stent was received fully covered and undeployed.Visual inspection found the outer clear sheath kinked.During functional inspection, the guidewire was loaded and the delivery system was actuated by sliding the handle back along the stainless-steel tube, and the stent was deployed without any problems.No other problems were noted with the stent and delivery system.Product analysis did not confirm the reported event of stent partially deployed.It is most likely that procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied) resulted in the observed event of outer clear sheath kinked.However, there is no indication of the reported event because the stent was received fully covered and undeployed and was able to be deployed during functional inspection.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral colonic stent was used to treat a malignant intestinal obstruction during a stent placement procedure performed on (b)(6) 2023.The location of the lesion blocked the intestinal cavity and is highly edematous.During the procedure, the stent was partially deployed; however, the patient's pain worsened.Consequently, the procedure was stopped, and the stent was removed partially deployed on the delivery system.The procedure was not completed due to the same device not being available.The patient's condition at the conclusion of the procedure was reported to be stable.In the physician's assessment, the pain was caused by the intestinal obstruction and there was no relationship with the wallflex enteral stent.The pain was resolved by gastrointestinal decompression and cleansing enema.

• Brand Name: WALLFLEX COLONIC
• Common Device Name: STENT, COLONIC, METALIC, EXPANDABLE
• 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: 18778326
• Report Number: 3005099803-2024-00631
• Device Sequence Number: 18238416
• Product Code: MQR
• UDI-Device Identifier: 08714729456520
• UDI-Public: 08714729456520
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K061877
• 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): 04/10/2024

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: 09/26/2024
• Device Model Number: M00565050
• Device Catalogue Number: 6505
• Device Lot Number: 0030225713
• 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: 01/31/2024
• Supplement Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2022
• 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 Age: 86 YR
• Patient Sex: Female
• Patient Weight: 60 KG