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

Model Number M00565030

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2023

Event Type  Injury  

Manufacturer Narrative

Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf impact code f2301 is being used to capture the additional device required to remove the stent.Imdrf impact code f23 is being used to capture the stent removal procedure.

Event Description

It was reported to boston scientific corporation that a wallflex enteral duodenal stent was to be implanted in the intestinal tract to treat a malignant 9 cm intestinal stenosis during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous.On (b)(6) 2023, post-procedure, prior to discharge of the patient, the stent was noticed to have dislodged and migrated from the anatomical implant site.The stent was removed from the patient using forceps, and another wallflex enteral duodenal stent was implanted to complete the procedure.There were no patient complications reported as a result of this event, and the patient's condition after the procedure was reported to be stable.

Manufacturer Narrative

Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf impact code f2301 is being used to capture the additional device required to remove the stent.Imdrf impact code f23 is being used to capture the stent removal procedure.Block h10: the wallflex enteral duodenal stent and delivery system were received for analysis.Visual inspection found that the stent was fully expanded and deployed from the delivery system, and the inner sheath was kinked.No other damages were noted with the stent or the delivery system.Product analysis did not confirm the reported event of a stent migration because this happened during the procedure and there was no objective evidence or descriptive conditions to confirm this reported event.Moreover, stent migration is a known potential adverse event associated with the use of the device and is documented in the labeling (including both short- or long-term known complications or adverse reactions).The investigation also concluded that the additional investigation finding of an inner sheath kinked was most likely due to procedural factors such as lesion characteristics, the handling of the device, and the technique used by the physician (force applied), which could have resulted in the damage encountered in the device.Therefore, a review and analysis of all available information indicated that the most probable cause is known inherent risk of device.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.

Event Description

It was reported to boston scientific corporation that a wallflex enteral duodenal stent was to be implanted in the intestinal tract to treat a malignant 9 cm intestinal stenosis during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous.On (b)(6) 2023, post-procedure, prior to discharge of the patient, the stent was noticed to have dislodged and migrated from the anatomical implant site.The stent was removed from the patient using forceps, and another wallflex enteral duodenal stent was implanted to complete the procedure.There were no patient complications reported as a result of this event, and the patient's condition after the procedure was reported to be stable.

• 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: 17911388
• MDR Text Key: 325345724
• Report Number: 3005099803-2023-05331
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/08/2024

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 Expiration Date: 01/31/2024
• Device Model Number: M00565030
• Device Catalogue Number: 6503
• Device Lot Number: 0028775425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2023
• Initial Date FDA Received: 10/11/2023
• Supplement Dates Manufacturer Received: 12/13/2023
• Supplement Dates FDA Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 61 KG