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

Model Number M00565030

Device Problem Migration (4003)

Patient Problems Feeding Problem (1850); Constipation (3274)

Event Date 08/11/2023

Event Type  Injury  

Event 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.

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.

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 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
• 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: 17635103
• MDR Text Key: 322098087
• Report Number: 3005099803-2023-04622
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 08714729456506
• UDI-Public: 08714729456506
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K062750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 08/11/2023
• Initial Date FDA Received: 08/28/2023
• Supplement Dates Manufacturer Received: 08/29/2023
• Supplement Dates FDA Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2022
• 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
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 55 KG