MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX COLONIC; STENT, COLONIC, METALIC, EXPANDABLE

Model Number	M00565050
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a wallflex colonic stent was to be implanted in the duodenum to treat a duodenal bulb stenosis during an intestinal stent retention procedure performed on (b)(6) 2024.The patient's anatomy was not dilated prior to stent placement.During the procedure, the stent was partially deployed, and it was observed that the mouth of the stent was in a shape of an irregular ring.The stent was removed from the patient partially deployed on the delivery system, and the procedure was completed using another wallflex colonic stent.There were no patient complications reported as a result of this event and the patient condition after the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: initial reporter facility address: (b)(6).Block h6: imdrf device code a0406 captures the reportable event of stent material deformation.
Additional Manufacturer Narrative
Block e1: initial reporter facility address:(b)(6).Block h6: imdrf device code a0406 captures the reportable event of stent material deformation.Block h11: a wallflex colonic stent was received for analysis.Visual examination of the returned device found the stent fully deployed and deformed.No other damages were noted to the stent and delivery system.The reported event of stent material deformation was confirmed as the stent was returned deformed.However, the reported event of stent partially deployed was not confirmed as the stent was returned fully deployed.The investigation concluded that the reported events and observed damages were likely due to factors encountered during the procedure.It is possible that the lesion characteristics, handling of the device, the technique used by the physician (force applied), limited the performance of the device and contributed to the stent deformity.Therefore, taking all available information into consideration, the most probable cause of the reported event is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex colonic stent was to be implanted in the duodenum to treat a duodenal bulb stenosis during an intestinal stent retention procedure performed on (b)(6) 2024.The patient's anatomy was not dilated prior to stent placement.During the procedure, the stent was partially deployed, and it was observed that the mouth of the stent was in a shape of an irregular ring.The stent was removed from the patient partially deployed on the delivery system, and the procedure was completed using another wallflex colonic stent.There were no patient complications reported as a result of this event and the patient condition after the procedure was reported to be stable.

• Brand Name: WALLFLEX COLONIC
• Common Device Name: STENT, COLONIC, METALIC, EXPANDABLE
• 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: 19559864
• Report Number: 3005099803-2024-02776
• Device Sequence Number: 15136110
• Product Code: MQR
• UDI-Device Identifier: 08714729456520
• UDI-Public: 08714729456520
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K061877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/25/2025
• Device Model Number: M00565050
• Device Catalogue Number: 6505
• Device Lot Number: 0030925379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2024
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2023
• 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
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 45 KG