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

Model Number	M00565050
Medical Device Problem Codes	Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral colonic stent was to be implanted to treat a 4cm malignant splenic intestinal stenosis during a stent implantation procedure performed on (b)(6) 2024.The patient's anatomy was tortuous.During the procedure, the stent could not be fully deployed.The stent was retracted and was removed from the patient fully covered by the outer sheath.The procedure was not completed.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.Block h11: a wallflex colonic stent was received for analysis.Visual examination of the returned device found the stent partially deployed and the outer sheath was kinked.No other damages were noted to the stent and delivery system.The reported event of stent failure to deploy was confirmed.Taking all available information into consideration, the investigation concluded that the reported event and observed damage 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 reported event and observed problems.Therefore, 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 enteral colonic stent was to be implanted to treat a 4cm malignant splenic intestinal stenosis during a stent implantation procedure performed on (b)(6) 2024.The patient's anatomy was tortuous.During the procedure, the stent could not be fully deployed.The stent was retracted and was removed from the patient fully covered by the outer sheath.The procedure was not completed.There were no patient complications as a result of this event.The patient's condition at the conclusion of 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: 19512980
• Report Number: 3005099803-2024-02723
• Device Sequence Number: 11626949
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

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: 03/06/2025
• Device Model Number: M00565050
• Device Catalogue Number: 6505
• Device Lot Number: 0031179516
• 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: 05/15/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2023
• 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: 46 YR
• Patient Sex: Male
• Patient Weight: 70 KG