MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX DUODENAL; STENT,METALLIC,EXPANDABLE,DUODENAL

Model Number M00565030

Device Problems Positioning Failure (1158); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on november 29, 2019 that a wallflex enteral duodenal stent was used during a colonoscopy with stent placement procedure performed on (b)(6) 2019.According to the complainant, during the procedure, when attempting to deploy the stent the distal end of the stent failed to open.The physician reconstrained the stent and it was removed from the patient.The procedure was completed with another wallflex enteral duodenal stent.There were no reported patient complications as a result of this event and the patient condition following the procedure was reported to be stable.Following removal of the reconstrained stent from the patient, the complainant tested the stent outside the patient and found the distal end still failed to open.Photos of the device following this testing outside the patient were provided and reviewed, the photos appear to show the stent partially deployed outside the patient after removal and the distal end of the stent appears to be damaged in some way so that the flare was not opening.Despite efforts, boston scientific has been unable to obtain additional information regarding the circumstances surrounding this event to date.

Manufacturer Narrative

Block h6: device problem code 2976 captures the reportable event of stent material deformation.Block h10: a wallflex biliary rx delivery system was received for analysis; the stent was received undeployed and fully covered by the outer sheath.Visual examination of the returned device found the outer sheath was kinked at 3 inch from the exterior tube handle (proximal end).During functional inspection, the stent was able to be deployed without issue.Some liquid residues were found around the stent but no issues with the stent itself were found.A photo of the device that the complainant provided seemed to show the stent partially deployed with some type of residue causing the distal end of the stent to not open; however upon receipt and analysis of the returned device no such residue could be found and the stent was able to be deployed and fully expanded upon deployment.Its likely the perceived stent damage in the photo was due to residue from the procedure and which was probably dissolved when the device was decontaminated.It is likely that factors such as handling of the device, the technique used by the physician and normal procedural difficulties encountered during the procedure which could have possibly affected the device performance and its integrity contributing to the failure experienced by the customer.Therefore, the most probable cause of the event is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.

Event Description

It was reported to boston scientific corporation on (b)(6) 2019 that a wallflex enteral duodenal stent was used during a colonoscopy with stent placement procedure performed on (b)(6) 2019.According to the complainant, during the procedure, when attempting to deploy the stent the distal end of the stent failed to open.The physician reconstrained the stent and it was removed from the patient.The procedure was completed with another wallflex enteral duodenal stent.There were no reported patient complications as a result of this event and the patient condition following the procedure was reported to be stable.Following removal of the reconstrained stent from the patient, the complainant tested the stent outside the patient and found the distal end still failed to open.Photos of the device following this testing outside the patient were provided and reviewed, the photos appear to show the stent partially deployed outside the patient after removal and the distal end of the stent appears to be damaged in some way so that the flare was not opening.Despite efforts, boston scientific has been unable to obtain additional information regarding the circumstances surrounding this event to date.

• Brand Name: WALLFLEX DUODENAL
• Type of Device: STENT,METALLIC,EXPANDABLE,DUODENAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9503025
• MDR Text Key: 189843861
• Report Number: 3005099803-2019-06188
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 08714729456506
• UDI-Public: 08714729456506
• Combination Product (y/n): N
• PMA/PMN Number: K062750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/09/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2021
• Device Model Number: M00565030
• Device Catalogue Number: 6503
• Device Lot Number: 0024307555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Initial Date Manufacturer Received: 11/29/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 02/13/2020
• Supplement Dates FDA Received: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1