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	Bowel Perforation (2668)
Date of Event	02/23/2021
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.The exact implant date is unknown; however, it was reported that the stent was implanted in (b)(6) 2020.(b)(4).The complainant indicated that the suspect device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2021 that a wallflex duodenal stent was implanted to treat a malignant stricture in the small bowel during a procedure performed in (b)(6) 2020.Reportedly, the patient's anatomy was not tortuous prior to stent placement.On (b)(6) 2021, post stent placement, imaging was performed and it was noted that the loops on the distal end of the stent had migrated into the small bowel causing a perforation.The patient was sent to surgery to seal the perforation.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 11553640
• Report Number: 3005099803-2021-01172
• Device Sequence Number: 14464878
• Product Code: MUM
• UDI-Device Identifier: 08714729456490
• UDI-Public: 08714729456490
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• 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 Model Number: M00565020
• Device Catalogue Number: 6502
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2021
• Initial 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