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

Model Number	M00565580
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Tissue Injury (4559)
Date of Event	10/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d2b: product code mqr, mum - reported here as the product code exceeded the maximum character limit for the designated field.Block e1: initial reporter facility name: (b)(6), reported here as the hcf exceeded the maximum character limit for the designated field.Block h6: imdrf device code a0406 captures the reportable event of stent deformation.Imdrf impact code f2301 captures the used of additional device to remove the stent from the patient.Block h11: a wallstent enteral delivery system was received for analysis; the stent was not returned.No damage was noted on the delivery system.Product analysis could not confirm the reported event of "stent material deformation", as the stent was not returned.Taking all available information into consideration, the device met all manufacturing specifications required and passed all the controls and inspections with no abnormalities were reported during the assembly process.Therefore, the most probable root cause for the complaint event is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that a wallstent enteral uncovered stent was used in the intestinal tract to treat a 2.8 cm lesion secondary to colon cancer during a procedure performed on (b)(6) 2024.During the procedure, when the stent was deployed, the bell mouth at the end of the stent scratched the patient's mucosa, causing bleeding.The stent was subsequently removed using foreign body forceps.After achieving hemostasis, the procedure was completed using another stent of the same type.The patient's condition following the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a wallstent enteral uncovered stent was used in the intestinal tract to treat a 2.8 cm lesion secondary to colon cancer during a procedure performed on (b)(6) 2024.During the procedure, when the stent was deployed, the bell mouth at the end of the stent scratched the patient's mucosa, causing bleeding.The stent was subsequently removed using foreign body forceps.After achieving hemostasis, the procedure was completed using another stent of the same type.The patient's condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Block d2b: product code mqr, mum - reported here as the product code exceeded the maximum character limit for the designated field.Block e1: initial reporter facility name: (b)(6) hospital, reported here as the hcf exceeded the maximum character limit for the designated field.Block h6: imdrf device code a0406 captures the reportable event of stent deformation.Imdrf impact code f2301 captures the used of additional device to remove the stent from the patient.Block h11: a wallstent enteral delivery system was received for analysis.However, the stent was not returned.Furthermore, a photo of the device was provided, and it was observed that there was no stent.No other problems were noted with the delivery system.Product analysis was unable to confirm the reported event of stent material deformation as stent was not returned.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu) / product label.Additionally, minor hemorrhage is known and documented within the ifu as potential adverse events associated with the used of this device.Taking all available information into consideration, the device met all manufacturing specifications required and passed all the controls and inspections with no abnormalities were reported during the assembly process.Since the stent was not returned; thus, a visual inspection of the stent could not be performed.Therefore, a review and analysis of all available information indicated the most probable cause is cause not established.

• Brand Name: WALLSTENT ENTERAL ENDOPROSTHESIS
• Common Device Name: STENT, COLONIC, METALLIC, 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: 20915176
• Report Number: 3005099803-2024-06380
• Device Sequence Number: 18292572
• 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): 01/27/2025

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: 11/03/2024
• Device Model Number: M00565580
• Device Catalogue Number: M00565580
• Device Lot Number: 0030479846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2022
• 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 Age: 75 YR
• Patient Sex: Male
• Patient Weight: 66 KG