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

Model Number	M00565030
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Feeding Problem (1850); Constipation (3274)
Date of Event	08/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral duodenal stent was implanted to treat an 8cm malignant intestinal stenosis in the intestinal tract during a stent implantation procedure performed on (b)(6) 2023.The patient's anatomy was noted to be tortuous.On an unknown date, the patient presented with the symptom of being unable to eat.This prompted the physician to check the stent placement and it was noted that the stent migrated.The stent was removed with biopsy forceps, and another wallflex enteral stent was used to complete the procedure.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf patient code e1203 captures the reportable event of patient inability to eat.Imdrf impact code f23 captures the reportable event of additional intervention performed to remove the migrated stent and implant another stent.
Additional Manufacturer Narrative
Blocks b5, d6a, d6b, h6 (patient codes) and h10 have been updated with the additional information received on august 9, 2023.Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf patient code e1203 captures the reportable event of patient inability to eat.Imdrf patient code e1007 captures the reportable event of patient inability to defecate.Imdrf impact code f23 captures the reportable event of additional intervention performed to remove the migrated stent and implant another stent.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral duodenal stent was implanted to treat an 8cm malignant intestinal stenosis in the intestinal tract during a stent implantation procedure performed on (b)(6), 2023.The patient's anatomy was noted to be tortuous.On an unknown date, the patient presented with the symptom of being unable to eat.This prompted the physician to check the stent placement and it was noted that the stent migrated.The stent was removed with biopsy forceps, and another wallflex enteral stent was used to complete the procedure.The patient's condition at the conclusion of the procedure was reported to be stable.Additional information received on august 29, 2023.It was reported that the stent was implanted on (b)(6) 2023.On (b)(6), 2023, stent migration was noted.On the same day, the migrated stent was removed, and another stent was implanted.The patient also experienced constipation due to stent migration.

• 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: 17635103
• Report Number: 3005099803-2023-04622
• Device Sequence Number: 20453288
• Product Code: MUM
• UDI-Device Identifier: 08714729456506
• UDI-Public: 08714729456506
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K062750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2023

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: 01/31/2024
• Device Model Number: M00565030
• Device Catalogue Number: 6503
• Device Lot Number: 0028775425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2022
• 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 Age: 58 YR
• Patient Sex: Male
• Patient Weight: 55 KG