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

Model Number	M00565570
Medical Device Problem Codes	Positioning Failure (1158); Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a wallstent enteral uncovered stent was to be implanted in the duodenum to treat a malignant stricture secondary to duodenal cancer during an intestinal stent implantation procedure performed on (b)(6) 2023.During the procedure, the stent could not be deployed inside the patient because there was resistance at the tip of the delivery system.The device was removed from the patient, and it was noted that a stent wire had punctured the tip of the outer sheath.Another wallstent enteral stent was used to complete the procedure.There were no patient complications reported as a result of this event, and the patient's condition after the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a041001 captures the reportable event of a stent wire that punctured the sheath.
Additional Manufacturer Narrative
Block d4 (lot number) has been updated with the additional information received on december 7, 2023.Block h6: imdrf device code a041001 captures the reportable event of a stent wire that punctured the sheath.Block h10: the wallstent enteral uncovered stent and delivery system were received for analysis.Visual inspection found that the stent was fully covered by the outer sheath and undeployed on the delivery system.The outer sheath was detached, and the inner sheath was kinked.Moreover, the visual, microscopic, and media inspection revealed that one of the wires of the stent had punctured the outer clear sheath.No other damages were noted with the stent or the delivery system.Product analysis confirmed the reported events of stent failure to deploy and stent wire punctured sheath.The investigation concluded that the reported events and the additional investigation findings of the outer sheath detached and inner sheath kinked were most likely due to procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied), which could have resulted in the damages encountered in the device and could have prevented the stent from deploying during the procedure.Therefore, a review and analysis of all available information indicated that the most probable cause is adverse event related to procedure.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a wallstent enteral uncovered stent was to be implanted in the duodenum to treat a malignant stricture secondary to duodenal cancer during an intestinal stent implantation procedure performed on (b)(6) 2023.During the procedure, the stent could not be deployed inside the patient because there was resistance at the tip of the delivery system.The device was removed from the patient, and it was noted that a stent wire had punctured the tip of the outer sheath.Another wallstent enteral stent was used to complete the procedure.There were no patient complications reported as a result of this event, and the patient's condition after the procedure was reported to be stable.

• 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: 18288589
• Report Number: 3005099803-2023-06514
• Device Sequence Number: 17809358
• Product Code: MQR
• UDI-Device Identifier: 08714729285069
• UDI-Public: 08714729285069
• 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): 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/16/2025
• Device Model Number: M00565570
• Device Catalogue Number: 6557
• Device Lot Number: 0031071348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2023
• 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
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 55 KG