MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX COLONIC SOFT STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEM; STENT, COLONIC, METALIC, EXPANDABLE

Model Number M00555770

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906)

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

Event Date 07/03/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation on (b)(6) 2023, that a wallflex enteral colonic stent was to be implanted in the colon to treat a 5 cm malignant colonic stricture during a colonic self-expandable metallic stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tight prior to stent placement.During stent deployment, the flared end of the stent would not open.The physician attempted to retract the stent by pushing the outer sheath back to the distal tip of the delivery system, but the outer sheath became stuck, and the stent wire broke.The wallflex colonic stent was removed from the patient partially deployed on the delivery system.The procedure was not completed as the patient was reported to be weak.There were no reported patient complications as a result of this event.Note: a photo of the complaint device was provided by the complainant and showed the stent outside of the patient partially covered by the outer sheath.One of the stent's wires can be observed to be broken.

Manufacturer Narrative

Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block e1: the initial reporter's facility name is (b)(6) hospital.Block h6: imdrf device code a0401 captures the reportable event of stent break.

Manufacturer Narrative

Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block e1: the initial reporter's facility name is miaoli general hospital, ministry of health and welfare.Block h6: imdrf device code a0401 captures the reportable event of stent break.Block h10: the wallflex colonic soft uncovered stent and anchor lock delivery system were received for analysis.A visual inspection was performed and found the stent was partially deployed on the delivery system.The outer clear sheath and the inner sheath were returned kinked.Functional inspection was performed by actuating the delivery system by sliding the back handle along the stainless-steel tube without problems, and no resistance was felt.A microscopic inspection confirmed that a stent wire was broken.A media inspection of the photo provided found that the stent was partially deployed, and a stent wire was broken.No other damages were noted on the stent or delivery system.Product analysis confirmed the reported events of stent break and stent partial deployment.The investigation concluded that stent break, stent partial deployment, and the additional investigation findings of inner sheath kinking and outer sheath kinking were most likely due to procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician, which could have resulted in the damages noted on the device and prevented the stent from deploying during the procedure.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A product labeling review identified that the device was used per the instructions for use (ifu) and product label.

Event Description

It was reported to boston scientific corporation on (b)(6) 2023, that a wallflex enteral colonic stent was to be implanted in the colon to treat a 5 cm malignant colonic stricture during a colonic self-expandable metallic stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tight prior to stent placement.During stent deployment, the flared end of the stent would not open.The physician attempted to retract the stent by pushing the outer sheath back to the distal tip of the delivery system, but the outer sheath became stuck, and the stent wire broke.The wallflex colonic stent was removed from the patient partially deployed on the delivery system.The procedure was not completed as the patient was reported to be weak.There were no reported patient complications as a result of this event.Note: a photo of the complaint device was provided by the complainant and showed the stent outside of the patient partially covered by the outer sheath.One of the stent's wires can be observed to be broken.

• Brand Name: WALLFLEX COLONIC SOFT STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEM
• 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: 17378723
• MDR Text Key: 319749365
• Report Number: 3005099803-2023-03968
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 08714729902591
• UDI-Public: 08714729902591
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K200257
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00555770
• Device Catalogue Number: 5577
• Device Lot Number: 0031444014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2023
• 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