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

Model Number	M00565580
Medical Device Problem Codes	Positioning Failure (1158); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A wallstent colonic and delivery system were received for analysis.The stent was returned fully covered and undeployed.Visual and microscopic inspection of the returned device found the stent wires were loose.Functional evaluation revealed that it was possible to deploy the stent by actuating the delivery system (slide the handle back along the stainless steel tube) without resistance felt.No other issues with the stent and delivery system were noted.The reported event of stent failure to deploy was not confirmed as the stent was deployed without resistance during functional evaluation.The investigation concluded that the reported event and the observed failures were likely due to factors encountered during the procedure.It may be that the technique used by the user, the interaction of the device with the scope and/or the patient anatomy limited the performance of the device and contributed to the reported event of stent failure to deploy.It may be that resistance felt during attempted deployment or if the stent was partially deployed could have contributed to the wires of the stent to loosen during procedure.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.
Event or Problem Description
It was reported to boston scientific corporation that a wallstent colonic uncovered stent was to be implanted in the colon to treat an intestinal stenosis during stent implantation procedure performed on (b)(6) 2020.During the procedure, the stent did not deploy.The stent was removed from the patient fully covered by the outer sheath.Another wallstent colonic stent was implanted to complete the procedure.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.This event has been deemed an mdr reportable event based on investigation result which revealed the stent wires were loose.

• 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
• MDR Report Key: 11377830
• Report Number: 3005099803-2021-00753
• Device Sequence Number: 3781462
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/25/2021

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: 05/19/2022
• Device Model Number: M00565580
• Device Catalogue Number: 6558
• Device Lot Number: 0025522785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 58