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

Model Number M00565060

Device Problem Material Integrity Problem (2978)

Patient Problem Bowel Perforation (2668)

Event Date 12/26/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation on december 27, 2022 that a wallflex enteral colonic stent was to be implanted in the colon during a stent placement procedure performed on (b)(6) 2022.During the procedure, it was noticed that the end point between the olive tip and the outer clear sheath got kinked and the patient's colon had perforated.In the physician's assessment, the kink on the delivery system was related to the perforation.Consequently, the patient underwent surgery to address the perforation.The stent was fully covered on the delivery system when it was removed from the patient.The procedure was not completed due to the patient's perforation.

Manufacturer Narrative

Block h6: patient code e1006 captures the reportable event of bowel perforation.Imdrf device code a04 captures the reportable event of tip damaged/defective.Block h10: a wallflex enteral colonic stent and delivery system were received for analysis.The stent was received fully expanded and deployed.Visual inspection found the inner sheath bent in the distal section.The stainless steel (handle) was kinked.The tip was inspected and no problems were noted.Device analysis did not identify the reported event of tip detachment of device or device component as there were no problems noted to the tip.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.Additionally, perforation is noted within the ifu as a potential complication associated with the use of the device.The investigation concluded that the observed events of inner sheath bent and stainless steel kinked were likely due to the procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician during the procedure.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.

Event Description

It was reported to boston scientific corporation on december 27, 2022 that a wallflex enteral colonic stent was to be implanted in the colon during a stent placement procedure performed on (b)(6) 2022.During the procedure, it was noticed that the end point between the olive tip and the outer clear sheath got kinked and the patient's colon had perforated.In the physician's assessment, the kink on the delivery system was related to the perforation.Consequently, the patient underwent surgery to address the perforation.The stent was fully covered on the delivery system when it was removed from the patient.The procedure was not completed due to the patient's perforation.

• 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: 16161274
• MDR Text Key: 307323564
• Report Number: 3005099803-2022-08076
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 08714729456537
• UDI-Public: 08714729456537
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2024
• Device Model Number: M00565060
• Device Catalogue Number: 6506
• Device Lot Number: 0029160135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2022
• 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 Outcome(s): Required Intervention