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

Model Number M00565020

Device Problem Device Stenosis (4066)

Patient Problem Obstruction/Occlusion (2422)

Event Date 01/26/2024

Event Type  Injury  

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 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.

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 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
• 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: 18935368
• MDR Text Key: 338066858
• Report Number: 3005099803-2024-01021
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 08714729456490
• UDI-Public: 08714729456490
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2024
• Supplement Dates Manufacturer Received: 03/21/2024
• Supplement Dates FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2023
• 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