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

Model Number	M00565040
Medical Device Problem Codes	Premature Activation (1484); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Imdrf device code (b)(4).Imdrf device code (b)(4).
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2023, that a wallflex enteral colonic stent was implanted in the proximal portion of the colon to treat a malignant tumor due to colonic cancer during a colonic stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not dilated prior to stent placement.During the procedure, the stent prematurely deployed.The patient underwent an additional colonoscopy in an attempt to remove the stent, however, it was not possible to retrieve the stent as it has already expanded, and retrieval may cause potential damage to the patient's mucosa and vascularized tumor.The stent remains implanted, and the procedure was completed with another wallflex enteral colonic stent.There were no patient complications reported as a result of this event.Note: no further information has been obtained despite good faith efforts.
Event or Problem Description
It was reported to boston scientific corporation on january 9, 2023, that a wallflex enteral colonic stent was implanted in the proximal portion of the colon to treat a malignant tumor due to colonic cancer during a colonic stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not dilated prior to stent placement.During the procedure, the stent prematurely deployed.The patient underwent an additional colonoscopy in an attempt to remove the stent, however, it was not possible to retrieve the stent as it has already expanded, and retrieval may cause potential damage to the patient's mucosa and vascularized tumor.The stent remains implanted, and the procedure was completed with another wallflex enteral colonic stent.There were no patient complications reported as a result of this event.The additional colonoscopy procedure was performed the next day, post stent deployment.During colonoscopy procedure, it was observed that the wallflex colonic stent had accommodated properly onto the colonic mucosa after it expanded.The stent was not removed, and the physician was comfortable leaving the stent in place.The additional colonoscopy was a scheduled procedure to check the status of the implanted wallflex colonic stent.Per the physician's assessment, the stent did not cause harm to the patient although it was not at the correct anatomical location because it prematurely deployed.
Additional Manufacturer Narrative
Blocks b5 and h6 (device code) have been updated with the additional information received on february 1, 2023, and february 14, 2023.Block h6: imdrf device code a150103 captures the reportable event of stent premature deployment.Block h11: block e4 has been corrected.

• 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: 16268534
• Report Number: 3005099803-2023-00266
• Device Sequence Number: 17743800
• Product Code: MQR
• UDI-Device Identifier: 08714729456513
• UDI-Public: 08714729456513
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K061877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 02/22/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: M00565040
• Device Catalogue Number: 6504
• Device Lot Number: 0028775437
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/09/2023
• Supplement Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown