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

Model Number	M00565590
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).(b)(4).
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022 that a wallstent colonic stent was to be implanted in the intestinal tract to treat a 5cm malignant stricture during a stent placement procedure performed on (b)(6) 2022.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the wallstent colonic stent could not be deployed.When the device was removed, the wallflex colonic stent accidentally deployed outside the patient.The procedure was completed with another wallstent colonic stent.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022 that a wallstent colonic stent was to be implanted in the intestinal tract to treat a 5cm malignant stricture during a stent placement procedure performed on (b)(6) 2022.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the wallstent colonic stent could not be deployed.When the device was removed, the wallflex colonic stent accidentally deployed outside the patient.The procedure was completed with another wallstent colonic stent.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: initial reporter address 1: (b)(6).Block h6: imdrf device code a150103 captures the reportable event of stent prematurely deployed outside patient.Block h10: a wallstent colonic delivery system was received for analysis; the stent was not returned.Visual examination of the returned device did not find any damages or issues to the delivery system.The reported event of stent prematurely deployed could not be confirmed; this problem occurred during the procedure, and it is not possible to replicate in the laboratory of analysis.The investigation concluded that the reported event was most likely due to procedural factors, such as lesion characteristics, handling and manipulation of the device.The technique used by the user, and/or normal procedural difficulties encountered during the procedure, limited the performance of the device and contributed to premature deployment of the stent.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A product labeling review identified that the device was used per the directions for use (dfu) / product label.

• 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: 15488728
• Report Number: 3005099803-2022-05527
• Device Sequence Number: 16633821
• 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): 11/07/2022

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: 10/13/2023
• Device Model Number: M00565590
• Device Catalogue Number: 6559
• Device Lot Number: 0028197913
• 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: 09/06/2022
• Supplement Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 09/26/2022
• Supplement Report FDA Received Date: 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2021
• 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: 81 YR
• Patient Sex: Male
• Patient Weight: 60 KG