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

Model Number M00565590

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 11/29/2023

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a wallstent enteral uncovered stent was to be implanted in the intestinal tract to treat a malignant 4 cm intestinal obstruction during a stent implantation procedure performed on (b)(6) 2023.The patient's anatomy was moderately tortuous.During the procedure, the burrs at the tip of the stent caused intestinal perforation.The patient was sent for surgery to address the perforation and remove the stent.The procedure was completed with another wallstent enteral uncovered stent.The patient's condition after the procedure was reported to be stable.

Manufacturer Narrative

Block h6: imdrf patient code e2114 captures the reportable patient complication of perforation.Imdrf impact code f19 captures the surgical procedure performed to address the perforation.

Manufacturer Narrative

Block h6: imdrf patient code e2114 captures the reportable patient complication of perforation.Imdrf impact code f19 captures the surgical procedure performed to address the perforation.Block h10: the wallstent enteral uncovered stent delivery system was returned for analysis.The stent was not received for analysis.Visual inspection found that the outer sheath and the inner sheath were kinked.No other damages were noted with the delivery system.Product analysis confirmed the reported events of perforation and surgical intervention as known potential adverse events associated with the use of the device and are documented in the labeling (including both short- or long-term known complications or adverse reactions).Additionally, the additional investigation findings of outer sheath and inner sheath kinking were most likely due to procedural factors such as lesion characteristics, the handling of the device, and the technique used by the physician (force applied), which could have resulted in the damages noted to the device.Therefore, a review and analysis of all available information indicated that the most probable cause is known inherent risk of device.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 that a wallstent enteral uncovered stent was to be implanted in the intestinal tract to treat a malignant 4 cm intestinal obstruction during a stent implantation procedure performed on (b)(6) 2023.The patient's anatomy was moderately tortuous.During the procedure, the burrs at the tip of the stent caused intestinal perforation.The patient was sent for surgery to address the perforation and remove the stent.The procedure was completed with another wallstent enteral uncovered stent.The patient's condition after 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: 18372071
• MDR Text Key: 331094979
• Report Number: 3005099803-2023-06796
• Device Sequence Number: 1
• Product Code: MQR
• 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: 02/16/2024

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: 12/10/2023
• Device Model Number: M00565590
• Device Catalogue Number: 6559
• Device Lot Number: 0028533718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2021
• 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): Other; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 75 KG