MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT RX BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00569810
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A wallstent biliary uncovered stent was received for analysis; the delivery system was not returned.The stent was received completely deployed.Visual inspection was performed and it was observed that the middle section of the stent was damaged and the wires were broken.No other issues with the stent were noted.The reported event of stent partially deployed was not confirmed as the stent was received completely deployed without the delivery system.It is possible that the factors encountered during the procedure, 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 contributing to the reported event of stent partially deployed.Additionally, the partially deployed stent and the amount of force applied to the device during attempted deployment may have caused the damage to the stent wires.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to the 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 biliary rx uncovered stent was to be implanted to treat a hilar cholangiocarcinoma during a stent placement procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was dilated prior to stent placement.During the procedure, the stent was unable to fully deploy inside the patient.Reportedly, the physician was unable to re-constrain the stent.The stent was removed from the patient partially deployed on the delivery system and another wallstent biliary stent was implanted to complete the procedure.Reportedly, the physician fully deployed the stent outside of the patient.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.Note: this event has been deemed an mdr-reportable event based on the investigation results which revealed that the stent was damaged.

• Brand Name: WALLSTENT RX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11300432
• Report Number: 3005099803-2021-00445
• Device Sequence Number: 12020861
• Product Code: FGE
• UDI-Device Identifier: 08714729456728
• UDI-Public: 08714729456728
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K030107
• 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): 02/09/2021

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: 12/17/2021
• Device Model Number: M00569810
• Device Catalogue Number: 6981
• Device Lot Number: 0025612039
• 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: 01/20/2021
• Initial Report FDA Received Date: 02/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1