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

Model Number M00565050

Device Problems Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/20/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 337415520
• Report Number: 3005099803-2024-00631
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 08714729456520
• UDI-Public: 08714729456520
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K061877
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: 03/20/2024
• Supplement Dates FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 60 KG