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

Model Number	M00565020
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	01/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0106 captures the reportable event of stent obstruction within device.Imdrf patient code e2328 captures the reportable event of bowel obstruction.Imdrf impact code f2202 captures the reportable event of endoscopic procedure.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex duodenal stent was implanted in the duodenum to treat a malignant gastroduodenal stricture during an upper gastrointestinal (gi) endoscopy procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent was successfully deployed.On (b)(6) 2024, at an outside hospital (ohs) the patient presentation was consistent with a small bowel obstruction related to a known duodenal obstruction and occluded stent.Recommended transfer for endoscopy to replace the duodenal stent.On (b)(6) 2024, the patient underwent upper gastrointestinal (gi) endoscopy, and an acquired extrinsic stenosis was found in the third portion of the duodenum associated with epithelial ingrowth resulting in partial obstruction of the proximal portion of the stent and was partially traversed using hybrid colonoscope.The stent remains implanted.
Additional Manufacturer Narrative
Block b5 was updated based on the additional information received on march 21, 2024.Block h6: imdrf device code a0106 captures the reportable event of stent obstruction within device.Imdrf patient code e2328 captures the reportable event of bowel obstruction.Imdrf impact code f2202 captures the reportable event of endoscopic procedure.Imdrf impact code f2301 captures the reportable event of a nasogastric tube (ngt) was placed.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex duodenal stent was implanted in the duodenum to treat a malignant gastroduodenal stricture during an upper gastrointestinal (gi) endoscopy procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent was successfully deployed.On (b)(6) 2024, at an outside hospital (ohs) the patient presentation was consistent with a small bowel obstruction related to a known duodenal obstruction and occluded stent.Recommended transfer for endoscopy to replace the duodenal stent.On (b)(6) 2024, the patient underwent upper gastrointestinal (gi) endoscopy, and an acquired extrinsic stenosis was found in the third portion of the duodenum associated with epithelial ingrowth resulting in partial obstruction of the proximal portion of the stent and was partially traversed using hybrid colonoscope.The stent remains implanted.Additional information received on march 21, 2024: nasogastric tube (ngt) was placed with 1 liter output gastric contents was done to address the stent occlusion.

• 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: 18935368
• Report Number: 3005099803-2024-01021
• Device Sequence Number: 20589944
• Product Code: MUM
• UDI-Device Identifier: 08714729456490
• UDI-Public: 08714729456490
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K062750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2024

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: 07/20/2025
• Device Model Number: M00565020
• Device Catalogue Number: 6502
• Device Lot Number: 0032059734
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2023
• 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: Unknown