MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT ENTERAL ENDOPROSTHESIS; STENT, COLONIC, METALIC, EXPANDABLE

Model Number M00565590

Device Problem Positioning Problem (3009)

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

Event Date 01/30/2023

Event Type  Injury  

Manufacturer Narrative

Imdrf device code a1502 captures the reportable device malfunction of stent positioning issue.

Event Description

It was reported to boston scientific corporation on (b)(6) 2023, that a wallstent colonic uncovered stent was to be implanted in the colon to treat a stricture due to colon cancer during an intestinal stent implantation procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the stent was deployed halfway; however, a part of the stent mesh was embedded in the intestinal tract tissue, and the stent could not be re-sheathed, consequently, the stent was deployed in an incorrect location.The stent was then removed from the patient with forceps, and another wallstent colonic stent was implanted to complete the procedure.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

Imdrf device code (b)(6) captures the reportable device malfunction of stent positioning issue.The wallstent delivery system was received for analysis; the stent was not returned.Visual examination of the returned device did not find any damages or issues to the delivery system.Product analysis did not confirm the reported device malfunction of stent positioning issue.The investigation concluded that this event cannot be confirmed because it happened during the procedure and is not possible to replicate in the laboratory for analysis.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.Furthermore, the event of stent positioning issue is considered an adverse event associated with the use of the device, as indicated in the product labeling.Therefore, review and analysis of all available information indicated that the most probable cause is known inherent risk of device.

Event Description

It was reported to boston scientific corporation on january 31, 2023, that a wall stent colonic uncovered stent was to be implanted in the colon to treat a stricture due to colon cancer during an intestinal stent implantation procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the stent was deployed halfway; however, a part of the stent mesh was embedded in the intestinal tract tissue, and the stent could not be re-sheathed, consequently, the stent was deployed in an incorrect location.The stent was then removed from the patient with forceps, and another wallstent colonic stent was implanted to complete the procedure.There were no reported patient complications as a result of this event.The patient's condition following the procedure was reported to be stable.

• Brand Name: WALLSTENT ENTERAL ENDOPROSTHESIS
• 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: 16409604
• MDR Text Key: 309886484
• Report Number: 3005099803-2023-00866
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 08714729285083
• UDI-Public: 08714729285083
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K000281
• 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: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2024
• Device Model Number: M00565590
• Device Catalogue Number: 6559
• Device Lot Number: 0028897585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2023
• Initial Date FDA Received: 02/21/2023
• Supplement Dates Manufacturer Received: 03/07/2023
• Supplement Dates FDA Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2022
• 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: 76 YR
• Patient Sex: Male
• Patient Weight: 56 KG