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

Model Number	M00565590
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	08/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an wallstent enteral uncovered stent was used during an intestinal stent implantation procedure performed on (b)(6) 2024.During the procedure, the stent was deployed, and it was found that the tail end of the stent was scattered, and the mucosa was damaged.The stent was removed from the patient with forceps, and the procedure was completed with another of the same device.There was no patient complication reported as a result of this event.The patient's condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: the initial reporter's facility name is (b)(6) hospital.Block h6: imdrf device code a0406 captures the reportable event of stent material deformation.Imdrf impact code f2301 captures the additional device used to remove the stent.
Additional Manufacturer Narrative
Block e1: the initial reporter's facility name is (b)(6).Block h6: imdrf device code a0406 captures the reportable event of stent material deformation.Imdrf impact code f2301 captures the additional device used to remove the stent, block h11: a wallstent enteral uncovered stent and delivery system were received for analysis.The stent was returned fully deployed and expanded.Visual inspection revealed that the stent was deformed.No other damages were noted on the stent or the delivery system.Product analysis confirmed the reported event of stent material deformation.Procedural factors, such as lesion characteristics, handling of the device, technique used by the physician, and/or the amount of force applied to the device, most likely contributed to the deformation of the stent.Therefore, a review and analysis of all available information indicate that the most probable cause is an adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an wallstent enteral uncovered stent was used during an intestinal stent implantation procedure performed on (b)(6) 2024.During the procedure, the stent was deployed, and it was found that the tail end of the stent was scattered, and the mucosa was damaged.The stent was removed from the patient with forceps, and the procedure was completed with another of the same device.There was no patient complication reported as a result of this event.The patient's condition following the procedure was reported to be stable.

• 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: 20128931
• Report Number: 3005099803-2024-04310
• Device Sequence Number: 3101659
• Product Code: MQR
• UDI-Device Identifier: 08714729285083
• UDI-Public: 08714729285083
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2024

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: 09/15/2024
• Device Model Number: M00565590
• Device Catalogue Number: 6559
• Device Lot Number: 0030160563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2024
• Supplement Date Received by Manufacturer: 10/06/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2022
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 66 KG