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

Model Number	M00565040
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: STENT, COLONIC, METALIC, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12214485
• Report Number: 3005099803-2021-03673
• Device Sequence Number: 4672377
• Product Code: MQR
• UDI-Device Identifier: 08714729456513
• UDI-Public: 08714729456513
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K061877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1