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

Model Number M00565040

Device Problems Break (1069); Difficult to Remove (1528)

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

Event Date 06/30/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A wallflex colonic stent was received for analysis; the delivery system was not returned.Visual inspection was performed and it was noted that the stent wires were broken and loose.No other issues with the stent was noted.The reported event of stent break was confirmed; the stent was inspected and found that the wires were broken and loose.The reported event of delivery system difficult to remove could not be confirmed as this failure occurred during the procedure and is not possible to replicate in the laboratory of analysis.The investigation concluded that the reported events and the observed failure were likely due to factors encountered during the procedure.Handling and manipulation of the delivery system and the scope during the removal process could have caused resistance contributing to the reported event of delivery system difficult to remove.Also, it may be that when the stent was removed together with the delivery system, it caused the damage noted to the stent wires.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to the procedure.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

It was reported to boston scientific corporation on june 30, 2021 that a wallflex colonic stent was to be implanted to treat a rectal cancer during a stent placement procedure performed on (b)(6) 2021.During the procedure, the stent was able to be deployed; however, when the delivery system was removed, the stent came out along with the delivery system.Reportedly, the wire of the proximal part of the stent was broken.The procedure was completed with another wallflex colonic stent.There were no patient complications reported as a result of this event.

• Brand Name: WALLFLEX COLONIC
• Type of Device: 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: 12214485
• MDR Text Key: 263142189
• Report Number: 3005099803-2021-03673
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 08714729456513
• UDI-Public: 08714729456513
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K061877
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/22/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2022
• Device Model Number: M00565040
• Device Catalogue Number: 6504
• Device Lot Number: 0026000382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2021
• Initial Date FDA Received: 07/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2020
• 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