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

Model Number M00565010

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).A wallflex duodenal stent was received for analysis; the delivery system was not returned.Visual inspection was performed and the stent was received with fecal material.The stent and flares of the device were deformed and damaged.No other issues were noted to the stent.The reported event of stent material deformation was confirmed.The reported event was likely due to factors encountered during the procedure.It may be that how the device was handled or manipulated and/or the techniques used by the user during attempted deployment contributed to the noted stent material deformation.Additionally, it is possible that the loops of the stent were stuck during deployment, and could have contributed to stent material deformation; therefore the stent could no longer be reconstrained.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.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

Event Description

It was reported to boston scientific corporation that a wallflex duodenal stent was to be implanted to treat a gastric outlet obstruction in the duodenum during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, when the physician attempted to deploy the stent, the stent did not deploy as it normally would and began to unravel.The physician tried to reconstrain the stent but it was unsuccessful.Reportedly, the stent was removed from the patient partially deployed on the delivery system and another wallflex duodenal stent was implanted to complete the procedure.There were no patient complications as a result of this event.Note: this event has been deemed a mdr-reportable event based on investigation results which revealed that the stent was deformed and damaged.Additional information was received from the complainant on january 08, 2021, reporting that the stent began to "unravel" when attempted to deploy the stent.The stent was then fully deployed inside the patient's duodenum because it was deformed.The stent was removed from the patient with rat tooth forceps and another wallfex duodenal stent was implanted to complete the procedure.

• Brand Name: WALLFLEX DUODENAL
• Type of Device: STENT,METALLIC,EXPANDABLE,DUODENAL
• 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: 11174434
• MDR Text Key: 227050838
• Report Number: 3005099803-2020-06761
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 08714729456483
• UDI-Public: 08714729456483
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/14/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2022
• Device Model Number: M00565010
• Device Catalogue Number: 6501
• Device Lot Number: 0025505862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2020
• Initial Date FDA Received: 01/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention