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

Model Number	M00565010
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis.Upon completion of the failure 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 wallflex duodenal stent was to be implanted to treat a duodenal obstruction during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2021.During the procedure, the stent was able to be deployed; however, it was noted that the stent became unraveled.The stent was removed using grasper forcep.The procedure was completed with another wallflex duodenal stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Blocks d7a, e1 (initial reporter's title, first name, last name), e3 (occupation) and h8 have been updated with additional information received on march 01, 2021.Block h6: medical device problem code a0406 captures the reportable event of stent material deformation.Block h10: a wallflex duodenal stent and delivey system were received for analysis.Visual examination of the returned device found the stent wire unraveled and deformed.The outer blue sheath was kinked approximately at 33 cm from the deployment hub.The stainless steel handle was slightly bent.The inner sheath was kinked near the middle ro marker.A media inspection was performed based on the photo provided by the complainant and noted that the wires of the stent unraveled.No other issues were noted to the stent and delivery system.The damages noted to the device were likely due to procedural factors encountered during the procedure.It may be that the interaction of the device with the scope, the technique used by the user, and/or the patient anatomy, limited the performance of the device and could have caused the resistance felt during stent deployment.The excessive force applied to the delivery system might have caused kink in the handle, in the inner and outer sheath.The reported event of stent material deformation was confirmed; the wires of the stent were unraveled.Most likely, anatomy of the patient (malignant duodenal obstruction) contributed to stent deformation.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to patient condition.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu)/ product label.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2021 that a wallflex duodenal stent was to be implanted to treat a duodenal obstruction during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6), 2021.During the procedure, the stent was able to be deployed; however, it was noted that the stent became unraveled.The stent was removed using grasper forcep.The procedure was completed with another wallflex duodenal stent.There were no patient complications reported as a result of this event.

• Brand Name: WALLFLEX DUODENAL
• Common Device Name: STENT,METALLIC,EXPANDABLE,DUODENAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11385878
• Report Number: 3005099803-2021-00790
• Device Sequence Number: 3444074
• Product Code: MUM
• UDI-Device Identifier: 08714729456483
• UDI-Public: 08714729456483
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K062750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2021

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: 11/27/2022
• Device Model Number: M00565010
• Device Catalogue Number: 6501
• Device Lot Number: 0026428878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention