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

Model Number	M00565580
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) (1946)
Date of Event	11/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2021 that a wallstent enteral uncovered stent was implanted to treat a malignant colorectal tumor during a stent placement procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was not tortuous.During the procedure, the stent deployed prematurely; the stent penetrated into the patient's mucosa and caused bleeding.A balloon and placement of another stent was used to address the bleeding and complete the procedure.The patient's condition at the conclusion of the procedure was reported to be stable.
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 (b)(6) 2021 that a wallstent enteral uncovered stent was implanted to treat a malignant colorectal tumor during a stent placement procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was not tortuous.During the procedure, the stent deployed prematurely; the stent penetrated into the patient's mucosa and caused bleeding.A balloon and placement of another stent was used to address the bleeding and complete the procedure.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: medical device problem code a150103 captures the reportable event of stent premature deployment.Block h10: a wallstent enteral delivery system was received for analysis; the stent was not returned.Visual inspection was performed and found the outer blue sheath was returned kinked.No other issues were noted to the delivery system.The reported event of stent prematurely deployed could not be confirmed as the stent was fully deployed during the procedure and the failure cannot be functionally or visually verified.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 directions for use (dfu) / product label.Additionally, the reported event of hemorrhage was noted within the instructions for use (ifu) as a known potential adverse event related to the use of the device.Taking all available information into consideration, the investigation concluded that the reported events and the observed failure were most likely due to anatomical and procedural factors encountered during the procedure.It may be that handling and manipulation of the device during procedure could have led to the kinked outer blue sheath.The kink could have led to excess force used during deployment resulting in the stent prematurely deploying and the stent penetrating into the patient's mucosa.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Block h11: blocks e1 (initial reporter title, first name, last name, facility name, address 1 and 2, city, state, post code, phone number, email address and fax number) e2 and e3 have been corrected.

• 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: 12891012
• Report Number: 3005099803-2021-06174
• Device Sequence Number: 14544160
• 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
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• 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): 12/28/2021

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: 06/12/2022
• Device Model Number: M00565580
• Device Catalogue Number: 6558
• Device Lot Number: 0025592024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2021
• Supplement Date Received by Manufacturer: 12/04/2021
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 12/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2020
• 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
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 62 KG