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

Model Number M00565050

Device Problem Activation Failure (3270)

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

Event Date 10/10/2023

Event Type  Injury  

Manufacturer Narrative

Block e1: the initial reporter's phone number is (b)(6).Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand.

Event Description

It was reported to boston scientific corporation that a wallflex enteral colonic stent was to be implanted in the intestine to treat an intestinal obstruction during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous.During the procedure, the stent was fully deployed; however, the stent was unable to expand.The stent was removed with forceps and another wallflex enteral stent was used to complete the procedure.In addition, it was noted that action taken by the physician to resolve the event also included observation.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block e1: the initial reporter's phone number is (b)(6).Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand.Block h10: a wallflex enteral colonic delivery system was received for analysis; the stent was not returned.Visual inspection found the outer clear sheath kinked.The stainless steel was bent and detached.No other problems were noted with the delivery system.The reported event of stent failure to expand was not confirmed as the stent was not returned.It is most likely that procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied) resulted in the observed events of outer clear sheath kinked and stainless steel bent and detached.The device meets all manufacturing specifications required, passed all the controls and inspections, and no abnormalities were reported during the assembly process.There is no indication of what the customer reported because the stent was not returned.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.

Event Description

It was reported to boston scientific corporation that a wallflex enteral colonic stent was to be implanted in the intestine to treat an intestinal obstruction during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous.During the procedure, the stent was fully deployed; however, the stent was unable to expand.The stent was removed with forceps and another wallflex enteral stent was used to complete the procedure.In addition, it was noted that action taken by the physician to resolve the event also included observation.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 18079838
• MDR Text Key: 327484114
• Report Number: 3005099803-2023-05857
• Device Sequence Number: 1
• Product Code: MQR
• 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: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• 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: 0029736618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2022
• 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: 52 YR
• Patient Sex: Male
• Patient Weight: 72 KG