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 Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946); Bowel Perforation (2668)

Event Date 08/17/2022

Event Type  Injury  

Event Description

It was reported to boston scientific corporation on august 18, 2022 that a wallstent enteral uncovered stent was to be implanted in the colorectum to treat a 4.5 cm stricture during an intestinal stent implantation procedure performed on (b)(6), 2022.The patient's anatomy was tight and was not dilated prior to stent placement.During the procedure, the stent was able to be deployed; however, the strut on both ends of the stent punctured the patient's intestinal tract.Enteroscope was used and bleeding was noted.Electric coagulation hemostasis was done to treat the bleeding and the bleeding was resolved.The wallstent enteral stent was removed from the patient using snares and another wallstent device was implanted to complete the procedure.The patient condition after the procedure was reported to be stable.

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation on august 18, 2022 that a wallstent enteral uncovered stent was to be implanted in the colorectum to treat a 4.5 cm stricture during an intestinal stent implantation procedure performed on (b)(6) 2022.The patient's anatomy was tight and was not dilated prior to stent placement.During the procedure, the stent was able to be deployed; however, the strut on both ends of the stent punctured the patient's intestinal tract.Enteroscope was used and bleeding was noted.Electric coagulation hemostasis was done to treat the bleeding and the bleeding was resolved.The wallstent enteral stent was removed from the patient using snares and another wallstent device was implanted to complete the procedure.The patient condition after the procedure was reported to be stable.

Manufacturer Narrative

Block h6: imdrf patient code e2009 captures the reportable patient issue of laceration(s).Block h10: a wallstent enteral colonic stent delivery system was received for analysis; the stent was not returned.Visual examination found no damages to the delivery system.The reported event of patient laceration, hemorrhage, minor, additional device required, and minor injury/illness/impairment could not be confirmed as these patient complications occurred during the procedure.A product labeling review identified that the device was used per the directions for use (dfu) / product label.Furthermore, the reported patient condition of hemorrhage, is a known potential complication associated with the use of the device in the manufacturer's labeling (including both short or long term known complications or adverse reaction).Therefore, a review and analysis of all available information indicated the most probable cause is known inherent risk of device.

• 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: 15382454
• MDR Text Key: 299507272
• Report Number: 3005099803-2022-05092
• 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: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2022
• Device Model Number: M00565590
• Device Catalogue Number: 6559
• Device Lot Number: 0026445589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2020
• 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: 77 YR
• Patient Sex: Male
• Patient Weight: 69 KG