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

Model Number	M00565580
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Date of Event	01/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a wallstent enteral uncovered stent was implanted to treat a 4cm malignant intestinal stenosis during a stent placement procedure performed on (b)(6) 2024.The patient's anatomy was not tortuous.During the procedure, after placement of the stent, it was noted that the tail end of the stent was broken and had punctured the intestinal mucosa, causing bleeding.Consequently, another wallstent enteral stent was placed to cover and compress the bleeding.The stent was removed using forceps and the procedure was completed.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: the initial reporter's facility name is (b)(6).The initial reporter's phone number is (b)(6).Block h6: imdrf patient code e0506 captures the reportable event of hemorrhage, major.Imdrf patient code e2114 captures the reportable event of perforation.Imdrf device code a0401 captures the reportable event of stent break.
Event or Problem Description
It was reported to boston scientific corporation that a wallstent enteral uncovered stent was implanted to treat a 4cm malignant intestinal stenosis during a stent placement procedure performed on (b)(6) 2024.The patient's anatomy was not tortuous.During the procedure, after placement of the stent, it was noted that the tail end of the stent was broken and had punctured the intestinal mucosa, causing bleeding.Consequently, another wallstent enteral stent was placed to cover and compress the bleeding.The stent was removed using forceps and the procedure was completed.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: the initial reporter's facility name is (b)(6) hospital.The initial reporter's phone number is (b)(6).Block h6: imdrf patient code e0506 captures the reportable event of hemorrhage, major.Imdrf patient code e2114 captures the reportable event of perforation.Imdrf device code a0401 captures the reportable event of stent break.Block h10: a wallstent enteral uncovered delivery system was received for analysis; the stent was not returned.Visual inspection found the outer and inner sheath kinked.No other problems were noted with the delivery system.The reported event of stent break was not confirmed.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 events of outer and inner sheath kinked.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.Additionally, hemorrhage, major and perforation are noted within the ifu as potential adverse events associated with the use of the device.There is no indication on the reported event because only the delivery system was received, and the stent was not returned.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.

• 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: 18730997
• Report Number: 3005099803-2024-00578
• Device Sequence Number: 7256050
• 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
• 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): 04/17/2024

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: 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): Initial
• Initial Date Received by Manufacturer: 01/29/2024
• Supplement Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 04/17/2024
• 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: 86 YR
• Patient Sex: Male
• Patient Weight: 65 KG