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

Model Number	M00565580
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block e1: address 2: (b)(6); reported here as the address exceeded the character limit, 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 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
Blocks b5 and h6 (device code) have been updated with the additional information received of september 12, 2024.Block e1: address 2: (b)(6).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, imdrf device code a150207 captures the reportable event of stent difficult to remove.Block h11: only the delivery system was received for analysis; the wallstent enteral was not returned.Visual inspection revealed no damage to the delivery system.Product analysis could not confirm the reported event of stent material deformation and stent delivery system difficult to remove.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu)/product label.Furthermore, hemorrhage (minor) is documented within the ifu as potential adverse event associated with the used of this device.However, there is insufficient information regarding the cause of the reported stent material deformation.Additionally, since the stent was not returned and the delivery system was received in a good condition, the investigation could not confirm the allegation.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that a wallstent ng enteral uncovered stent was used in the intestinal tract 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 12, 2024: it was reported that damaged wires were noted on the edge of the stent.The physician attempted to remove the stent from the patient using snares and forceps.
Additional Manufacturer Narrative
Block h11 has been corrected.Block e1: address 2: (b)(6).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.Imdrf device code a150207 captures the reportable event of stent difficult to remove.Block h11: only the delivery system was received for analysis; the wallstent enteral was not returned.Visual inspection revealed no damage to the delivery system.Product analysis could not confirm the reported event of stent material deformation and stent difficult to remove.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu) / product label.Furthermore, hemorrhage (minor) is documented within the ifu as potential adverse event associated with the used of this device.However, there is insufficient information regarding the cause of the reported stent material deformation.Additionally, since the stent was not returned and the delivery system was received in a good condition, the investigation could not confirm the allegation.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that a wallstent ng enteral uncovered stent was used in the intestinal tract 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 12, 2024*** it was reported that damaged wires were noted on the edge of the stent.The physician attempted to remove the stent from the patient using snares and forceps.

• 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: 20183498
• Report Number: 3005099803-2024-04419
• Device Sequence Number: 18217151
• 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,Followup
• Report Date (Section B): 01/21/2025

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: 09/15/2024
• Device Model Number: M00565580
• Device Catalogue Number: M00565580
• Device Lot Number: 0030160560
• 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: 08/13/2024
• Supplement Date Received by Manufacturer: 09/12/2024; 01/17/2025
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 10/09/2024; 01/21/2025
• 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: 81 YR
• Patient Sex: Male
• Patient Weight: 66 KG