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

Model Number	M00565060
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	12/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem 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.
Additional 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 or Problem 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
• 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: 16161274
• Report Number: 3005099803-2022-08076
• Device Sequence Number: 18009923
• Product Code: MQR
• UDI-Device Identifier: 08714729456537
• UDI-Public: 08714729456537
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2023

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: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2022
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2022
• 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: Required Intervention
• Patient Sex: Unknown