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

Model Number	M00565590
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) (1946); Bowel Perforation (2668)
Date of Event	08/17/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
(b)(4).
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3005099803-2022-05092
• Device Sequence Number: 20237407
• Product Code: MQR
• UDI-Device Identifier: 08714729285083
• UDI-Public: 08714729285083
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K000281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2022

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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 69 KG