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	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of stent material deformation.Imdrf impact code f2301 captures the use of a second stent to complete the procedure.
Event or Problem Description
It was reported to boston scientific corporation that a wallstent ng enteral uncovered stent was used in the intestinal tract for intestinal stenosis during an intestinal stent placement procedure performed on (b)(6) 2024.During the procedure, after deploying the stent, the "tip had burrs" which pricked the mucosa and resulted in bleeding.The stent could not be removed from the patient.Another wallstent enteral was implanted to complete the procedure.The patient's condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Block b5 has been updated with the additional information received on september 17, 2024.Block h6: imdrf device code a0406 captures the reportable event of stent material deformation imdrf impact code f2301 captures the use of a second stent to complete the procedure block h11: a wallstent enteral delivery system was received for analysis; the stent was not returned.Visual examination of the returned device found the sheath kinked.No other problems were noted with the delivery system.Product analysis could not confirm the reported event of stent material deformation as the stent was not returned.The investigation concluded that the observed problem of sheath kinked was likely due to factors encountered during the procedure.It may be that lesion characteristics, handling of the device and the technique used by the physician (force applied), limited the performance of the device and contributed to the observed problem.Taking all available information into consideration, the overall root cause of the reported event is no problem detected.A labeling review was performed and, from the information available, there is no information that this device was used in a manner inconsistent with the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a wallstent ng enteral uncovered stent was used in the intestinal tract for intestinal stenosis during an intestinal stent placement procedure performed on (b)(6) 2024.During the procedure, after deploying the stent, the "tip had burrs" which pricked the mucosa and resulted in bleeding.The stent could not be removed from the patient.Another wallstent enteral was implanted to complete the procedure.The patient's condition following the procedure was reported to be stable.***additional information received on september 17, 2024*** it was reported that the wires at the tip of the stent were lifted and bent.

• 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: 20257416
• Report Number: 3005099803-2024-04501
• Device Sequence Number: 8013599
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2024

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: 01/05/2025
• Device Model Number: M00565590
• Device Catalogue Number: 6559
• Device Lot Number: 0030800213
• 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: 08/23/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2023
• 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: Male
• Patient Weight: 66 KG