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

Model Number M00565060

Device Problems Mechanical Problem (1384); Difficult to Remove (1528)

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

Event Date 06/12/2023

Event Type  Injury  

Manufacturer Narrative

Block h6: imdrf device code a150207 captures the reportable event of delivery system difficult to remove.

Event Description

It was reported to boston scientific corporation on (b)(6) 2023 that a wallflex colonic stent was to be implanted to treat a 5cm malignant stenosis in the colon during a colon stent deployment procedure performed on (b)(6) 2023.The patient's anatomy was slightly tortuous.During the procedure, the stent was partially deployed; however, due to intestinal peristalsis and the positioning of the stent, it was attempted to be recaptured.During the attempted recapture, the delivery system got stuck, and the stent was unable to be fully recaptured.The physician then decided to remove the stent; however, the tip of the device was stuck in the intestinal wall.A foreign body forcep was used to remove the stent, and another wallflex colonic stent was used to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Event Description

It was reported to boston scientific corporation on june 14, 2023 that a wallflex colonic stent was to be implanted to treat a 5cm malignant stenosis in the colon during a colon stent deployment procedure performed on (b)(6) 2023.The patient's anatomy was slightly tortuous.During the procedure, the stent was partially deployed; however, due to intestinal peristalsis and the positioning of the stent, it was attempted to be recaptured.During the attempted recapture, the delivery system got stuck, and the stent was unable to be fully recaptured.The physician then decided to remove the stent; however, the tip of the device was stuck in the intestinal wall.A foreign body forcep was used to remove the stent, and another wallflex colonic stent was used to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6: imdrf device code a150207 captures the reportable event of delivery system difficult to remove.Block h10: a wallflex enteral colonic stent and delivery system were returned for analysis.Visual examination of the returned device found the stent fully deployed and damaged (wire broken, unraveled, and loose).The outer sheath and inner sheath were also kinked.No other issues were noted with the stent and delivery system.The observed failure of the outer sheath and inner sheath kinked were likely due to factors encountered during the procedure.It may be that lesion characteristics, handling of the device, and the technique used by the physician when trying to reconstrain the stent, limited the performance of the device and contributed to the outer sheath and inner sheath kinks.Additionally, the damages noted on the stent could have occurred during the removal of the stent.The reported event of delivery system difficult to remove and stent difficult to reconstrain cannot be confirmed as this occurred during the procedure, and it is not possible to replicate in the laboratory of analysis.Taking all available information into consideration, the investigation concluded that the reported events and observed failure were likely due to factors encountered during the procedure.Therefore, a review and analysis of the all the available information indicated that the most probable cause is adverse event related to procedure.

• 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: 17237859
• MDR Text Key: 318206526
• Report Number: 3005099803-2023-03537
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 08714729456537
• UDI-Public: 08714729456537
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K061877
• 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: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00565060
• Device Catalogue Number: 6506
• Device Lot Number: 0029676818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 63 KG