MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT ENTERAL ENDOPROSTHESIS; STENT, COLONIC, METALIC, EXPANDABLE

Model Number	M00565580
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	04/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation on april 20, 2023 that a wallstent enteral uncovered stent was implanted to treat a 3cm anastomotic stenosis in the intestinal tract during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous.During the procedure, post stent deployment, the "burr" on the tip of the stent punctured the mucous membrane which resulted to intestinal bleeding.Another wallstent enteral stent was placed for compression to resolve the bleeding and the procedure was completed.The patient's condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: patient code e1006 captures the reportable event of intestinal bleeding.
Additional Manufacturer Narrative
Block h6: patient code e1006 captures the reportable event of intestinal bleeding.Block h10: a wallstent enteral delivery system was received for analysis.The stent was not returned.During visual inspection, the delivery system was inspected and no problems were noted.The reported event of perforation, bowel could not be confirmed as this occurred during the procedure.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.Based on the available information, there is not enough evidence to establish the cause of the reported event as the stent was not returned for analysis.The investigation concluded that, without proper evaluation of the device, there is a lack of objective evidence or descriptive conditions of the event required to determine a probable cause of the event.
Event or Problem Description
It was reported to boston scientific corporation on(b)(6) 2023 that a wallstent enteral uncovered stent was implanted to treat a 3cm anastomotic stenosis in the intestinal tract during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous.During the procedure, post stent deployment, the "burr" on the tip of the stent punctured the mucous membrane which resulted to intestinal bleeding.Another wallstent enteral stent was placed for compression to resolve the bleeding and the procedure was completed.The patient's condition following the procedure was reported to be stable.Additional information received on may 10, 2023.The stent remained implanted and is scheduled to be surgically removed on a later date.
Additional Manufacturer Narrative
Blocks b5, d6b (rfb explant date), and h6 (impact codes) have been updated with additional information received on may 10, 2023.Block h6: patient code e1006 captures the reportable event of intestinal bleeding.
Event or Problem Description
It was reported to boston scientific corporation on april 20, 2023 that a wallstent enteral uncovered stent was implanted to treat a 3cm anastomotic stenosis in the intestinal tract during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous.During the procedure, post stent deployment, the "burr" on the tip of the stent punctured the mucous membrane which resulted to intestinal bleeding.Another wallstent enteral stent was placed for compression to resolve the bleeding and the procedure was completed.The patient's condition following the procedure was reported to be stable.The stent remained implanted and is scheduled to be surgically removed on a later date.

• Brand Name: WALLSTENT ENTERAL ENDOPROSTHESIS
• 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: 16913042
• Report Number: 3005099803-2023-02474
• Device Sequence Number: 11325855
• Product Code: MQR
• UDI-Device Identifier: 08714729285076
• UDI-Public: 08714729285076
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K000281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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,Followup
• Report Date (Section B): 06/23/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: M00565580
• Device Catalogue Number: 6558
• Device Lot Number: 0029149728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/20/2023
• Supplement Date Received by Manufacturer: 04/20/2023; 06/08/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 05/15/2023; 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2022
• 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 Age: 60 YR
• Patient Sex: Male
• Patient Weight: 67 KG