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

Model Number M00565050

Device Problems Premature Activation (1484); Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)

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

Event Date 04/19/2023

Event Type  Injury  

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 3 cm malignant intestinal obstruction during a stenting procedure performed on (b)(6) 2023.The patient's anatomy was not dilated prior to stent placement.During the procedure, while the physician was deploying the stent, the inner sheath detached.The stent was removed from the patient partially deployed on the delivery system.The procedure was completed with another wallflex enteral colonic stent.There were no reported patient complications as a result of this event.The patient's condition following the procedure was reported to be stable.

Manufacturer Narrative

Block h6: imdrf device code a0501 captures the reportable event of inner sheath detached.

Manufacturer Narrative

Blocks b5 and h6 (device codes, impact codes) were updated with the additional information received on june 19, 2023, and july 3, 2023.Block h6: imdrf device code a150103 captures the reportable event of stent premature deployment.Block h10: the wallflex enteral colonic stent delivery system was received for analysis; the stent was not returned.A visual inspection of the returned delivery system found no damage to the inner sheath.The outer diameter of the clear and blue sheath was measured and found to be within specification.No problems were noted with the delivery system.Product analysis did not confirm the reported event of premature stent deployment.Based on the available information, there was no confirmation on what the customer indicated because this event occurred during the procedure, and it is not possible to replicate the event in the laboratory for analysis.Additionally, the device passed the visual and dimensional inspections during the product analysis.Therefore, review and analysis of all available information indicated that the most probable cause is no problem detected.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.

Event Description

It was reported to boston scientific corporation on may 18, 2023, that a wallflex enteral colonic stent was to be implanted in the colon to treat a 3 cm malignant intestinal obstruction during a stenting procedure performed on (b)(6) 2023.The patient's anatomy was not dilated prior to stent placement.During the procedure, while the physician was deploying the stent, the inner sheath detached.The stent was removed from the patient partially deployed on the delivery system.The procedure was completed with another wallflex enteral colonic stent.There were no reported patient complications as a result of this event.The patient's condition following the procedure was reported to be stable.It was reported that the inner sheath was not detached, and the stent was not partially deployed on the delivery system when it was removed from the patient; instead, the stent had prematurely deployed inside the patient and was removed.

Manufacturer Narrative

Blocks b5 and h6 (impact codes) were updated with the additional information received on july 7, 2023.Block h6: imdrf device code a150103 captures the reportable event of stent premature deployment.Block h10: the wallflex enteral colonic stent delivery system was received for analysis; the stent was not returned.A visual inspection of the returned delivery system found no damage to the inner sheath.The outer diameter of the clear and blue sheath was measured and found to be within specification.No problems were noted with the delivery system.Product analysis did not confirm the reported event of premature stent deployment.Based on the available information, there was no confirmation on what the customer indicated because this event occurred during the procedure, and it is not possible to replicate the event in the laboratory for analysis.Additionally, the device passed the visual and dimensional inspections during the product analysis.Therefore, review and analysis of all available information indicated that the most probable cause is no problem detected.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.

Event Description

It was reported to boston scientific corporation on may 18, 2023, that a wallflex enteral colonic stent was to be implanted in the colon to treat a 3 cm malignant intestinal obstruction during a stenting procedure performed on (b)(6) 2023.The patient's anatomy was not dilated prior to stent placement.During the procedure, while the physician was deploying the stent, the inner sheath detached.The stent was removed from the patient partially deployed on the delivery system.The procedure was completed with another wallflex enteral colonic stent.There were no reported patient complications as a result of this event.The patient's condition following the procedure was reported to be stable.Additional information received on june 19, 2023, and july 3, 2023.It was reported that the inner sheath was not detached, and the stent was not partially deployed on the delivery system when it was removed from the patient; instead, the stent had prematurely deployed inside the patient and was removed.Additional information received on july 7, 2023.It was reported that the prematurely deployed stent was not removed from the patient.

• 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: 17074931
• MDR Text Key: 316758469
• Report Number: 3005099803-2023-03030
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 08714729456520
• UDI-Public: 08714729456520
• 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,Followup
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00565050
• Device Catalogue Number: 6505
• Device Lot Number: 0029563836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2022
• 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: 49 YR
• Patient Sex: Female
• Patient Weight: 51 KG