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

Model Number	M00565010
Medical Device Problem Codes	Premature Activation (1484); Difficult to Remove (1528); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation on may 04, 2022 that a wallflex duodenal stent was to be implanted during a stent placement procedure performed on (b)(6) 2022.During the procedure, the stent deployed prematurely before reaching the reconstrainment limit mark.The stent coiled on itself and was deployed not in the intended anatomy.The stent was removed from the patient with difficulty due to incorrect placement and another wallflex duodenal stent was implanted to complete the procedure.There are no known patient complications due to this event.
Additional Manufacturer Narrative
Report source: medwatch report#: (b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• Brand Name: WALLFLEX DUODENAL
• Common Device Name: 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: 14522048
• Report Number: 3005099803-2022-02806
• Device Sequence Number: 12400087
• Product Code: MUM
• UDI-Device Identifier: 08714729456483
• UDI-Public: 08714729456483
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/27/2022

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: 11/22/2023
• Device Model Number: M00565010
• Device Catalogue Number: 6501
• Device Lot Number: 0028427439
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female