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

Model Number	M00565040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	09/01/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf patient code e2114 captures the reportable event of perforation.Imdrf impact code f19 captures the surgical intervention performed to address the perforation.Imdrf impact code f02 captures the reportable event of death.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral colonic stent was implanted in the transverse colon during a stent placement procedure performed on an unknown date.The patient's anatomy was tortuous.During the procedure, the patient had perforation.Subsequently, the patient underwent surgery to address the perforation; however, on an unknown date, post surgery, the patient passed away.The patient's cause of death is unknown; however, it was confirmed that the patient had many comorbidities and health problems prior to stent placement.In addition, the patient had an enlarged colon considerably increasing the risk of perforation.Furthermore, there were no problems reported on the wallflex enteral stent, however, the patient's anatomy was very difficult.

• Brand Name: WALLFLEX COLONIC
• 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: 17923304
• Report Number: 3005099803-2023-05444
• Device Sequence Number: 2957302
• Product Code: MQR
• UDI-Device Identifier: 08714729456513
• UDI-Public: 08714729456513
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K061877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/12/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: M00565040
• Device Catalogue Number: 6504
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; Death
• Patient Sex: Unknown