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

Model Number	M00565030
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral duodenal stent was 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.
Additional 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.
Additional 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 or Problem 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
• 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: 17911388
• Report Number: 3005099803-2023-05331
• Device Sequence Number: 15305045
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2023
• Supplement Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 61 KG