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

Model Number	M00565020
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	06/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.(b)(4).The complainant indicated that the device remains implanted; 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 or Problem Description
It was reported to boston scientific corporation on june 21, 2021 that a wallflex duodenal stent was implanted to treat a 4cm malignant gastric outlet obstruction in the duodenum/pylorus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2021.The patient's anatomy was tortuous.On (b)(6) 2021, the patient experienced discomfort and an endoscopy procedure was performed where it was noted that the stent migrated.The physician attempted to re-position the stent using rat tooth forceps; however, the physician was unsuccessful.A different sized wallflex duodenal stent was placed stent-in-stent to complete the procedure.The patient was prescribed npo (nothing by mouth) for two days to address the discomfort.The patient's condition was reported to be fully recovered.

• 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: 12150954
• Report Number: 3005099803-2021-03409
• Device Sequence Number: 11950015
• Product Code: MUM
• UDI-Device Identifier: 08714729456490
• UDI-Public: 08714729456490
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K062750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/12/2021

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 Model Number: M00565020
• Device Catalogue Number: 6502
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 07/12/2021
• 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