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

Model Number M00565060

Device Problems Positioning Failure (1158); Use of Device Problem (1670); Detachment of Device or Device Component (2907)

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

Event Date 09/18/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation on (b)(6), 2022, that a wallflex enteral colonic stent was to be implanted in the digestive tract to treat a malignant stricture and gastrointestinal bleeding during a stent placement procedure performed on (b)(6), 2022.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent was unable to deploy.When the delivery system was removed, the inner sheath got detached and was removed with forceps.The procedure was completed with another wallflex enteral stent.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.Note: it was reported that the wallflex enteral colonic stent was to be implanted to treat a gastrointestinal bleeding.Per the wallflex colonic stent system with anchor lock delivery system directions for use (dfu), "the device is indicated for the palliative treatment of colonic strictures produced by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures".The stent is not indicated for the treatment of gastrointestinal bleeding.

Manufacturer Narrative

Block b5 has been updated with additional information received on november 16, 2022 and november 25, 2022.Block h6: imdrf device code a0501 captures the reportable event of inner sheath detached.Block h10: a wallflex enteral colonic stent was received for analysis; the delivery system was not returned.The stent was received fully expanded and fully deployed.The stent was inspected and no problems were noted.The reported events of stent failure to deploy and inner shaft/sheath detachment of device or device component could not be confirmed as only the stent was received completely deployed and in good condition.A labeling review was performed, and from the information available, this device was used in a manner inconsistent with the ifu (instructions for use) / product label.The complainant reported that the wallflex enteral colonic stent was to be implanted to treat a gastrointestinal bleeding.The wallflex colonic stent system with anchor lock delivery system instructions for use (ifu) states "the device is indicated for the palliative treatment of colonic strictures produced by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures".However, there is no indication of what the customer reported because the delivery system was not returned and the stent was completely deployed.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 on september 20, 2022, that a wallflex enteral colonic stent was to be implanted in the digestive tract to treat a malignant stricture and gastrointestinal bleeding during a stent placement procedure performed on (b)(6) 2022.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent was unable to deploy.When the delivery system was removed, the inner sheath got detached and was removed with forceps.The procedure was completed with another wallflex enteral stent.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.Note: it was reported that the wallflex enteral colonic stent was to be implanted to treat a gastrointestinal bleeding.Per the wallflex colonic stent system with anchor lock delivery system directions for use (dfu), "the device is indicated for the palliative treatment of colonic strictures produced by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures".The stent is not indicated for the treatment of gastrointestinal bleeding.Additional information received on november 16, 2022 and november 25, 2022: prior to the procedure, the patient was not actively bleeding.The removal of the detached inner sheath did not also contribute to the bleeding.The source of the bleeding was from the ulcers in the intestine.Furthermore, the stent was placed at the site of the malignant stricture; however, the bleeding was not at the site of malignancy.

Event Description

It was reported to boston scientific corporation on september 20, 2022, that a wallflex enteral colonic stent was to be implanted in the digestive tract to treat a malignant stricture and gastrointestinal bleeding during a stent placement procedure performed on (b)(6), 2022.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent was unable to deploy.When the delivery system was removed, the inner sheath got detached and was removed with forceps.The procedure was completed with another wallflex enteral stent.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.Note: it was reported that the wallflex enteral colonic stent was to be implanted to treat a gastrointestinal bleeding.Per the wallflex colonic stent system with anchor lock delivery system directions for use (dfu), "the device is indicated for the palliative treatment of colonic strictures produced by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures".The stent is not indicated for the treatment of gastrointestinal bleeding.Additional information received on november 16, 2022 and november 25, 2022.Prior to the procedure, the patient was not actively bleeding.The removal of the detached inner sheath did not also contribute to the bleeding.The source of the bleeding was from the ulcers in the intestine.Furthermore, the stent was placed at the site of the malignant stricture; however, the bleeding was not at the site of malignancy.Update based on medical safety review on december 15, 2022.The stent was intended to treat a malignant stricture; however, since the gastrointestinal bleeding was not noted prior to procedure nor was the bleeding at the site of stent placement, the stent was not used to treat a gastrointestinal bleed.

Manufacturer Narrative

Block h6: imdrf device code a0501 captures the reportable event of inner sheath detached.Block h10: a wallflex enteral colonic stent was received for analysis; the delivery system was not returned.The stent was received fully expanded and fully deployed.The stent was inspected and no problems were noted.Product analysis could not confirm the reported events of stent failure to deploy and inner shaft/sheath detachment of device or device component.There is no indication of what the customer reported because the delivery system was not returned, only the fully deployed stent.Therefore, a review and analysis of all available information indicated 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.Block h11: blocks b5, h6 (device codes), and h10 (device analysis) have been corrected based on the review of the complaint.

• 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: 15587478
• MDR Text Key: 301570365
• Report Number: 3005099803-2022-05982
• 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,Followup
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: M00565060
• Device Catalogue Number: 6506
• Device Lot Number: 0027936221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2021
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 60 KG