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

Model Number	M00565590
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on march 03, 2022 that a wallstent enteral stent was to be implanted to treat a 4 cm intestinal tumor in the colon during a colon stent implantation performed on (b)(6) 2022.Reportedly, the patient's anatomy was not tortuous prior to stent placement.During the procedure, the stent was fully deployed; however, after deployment, it was observed on imaging that the stent moved out of its position.The patient was sent for a laparotomy where the stent was removed.The procedure was completed with a different device.There were no patient complications reported 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 h6: medical device problem code a1502 captures the reportable event of stent positioning issue.Impact code f1903 captures the reportable surgery performed to explant the stent.Block h10: a wallstent enteral delivery system was received for analysis; the stent was not returned.Visual examination of the returned device found the outer blue sheath and clear sheath were kinked.No other problems were noted to the delivery system.The damage noted to the outer sheath was most likely due to procedural factors encountered during the procedure.It may be that lesion characteristics, handling of the device, the techniques used by the user, and/or normal procedural difficulties, limited the performance of the device.Therefore, contributing to the sheath becoming kinked.The reported event of stent positioning could not be confirmed; the event occurred during the procedure and it is not possible to replicate in the laboratory of analysis.A product labeling review identified that the device was used per the directions for use (dfu) / product label.Additionally, stent misplacement is noted within the manufacturers labeling as a known possible adverse event related to the use of the device.Therefore, a review and analysis of all available information indicated the most probable cause is known inherent risk of device.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation on march 03, 2022 that a wallstent enteral stent was to be implanted to treat a 4 cm intestinal tumor in the colon during a colon stent implantation performed on march 02, 2022.Reportedly, the patient's anatomy was not tortuous prior to stent placement.During the procedure, the stent was fully deployed; however, after deployment, it was observed on imaging that the stent moved out of its position.The patient was sent for a laparotomy where the stent was removed.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 13904481
• Report Number: 3005099803-2022-01526
• Device Sequence Number: 4277256
• 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): 08/19/2022

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: 05/19/2022
• Device Model Number: M00565590
• Device Catalogue Number: 6559
• Device Lot Number: 0025522787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2022
• Supplement Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 03/25/2022
• Supplement Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2020
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 70 KG