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

Model Number	M00565110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Peritonitis (2252); Bowel Perforation (2668)
Date of Event	04/08/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).The patient expired, the stent remains implanted and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on april 9, 2021 that a wallflex colonic stent was implanted to minimize a 5 mm intestinal occlusion due to cancer during a colon stent placement procedure performed on (b)(6) 2021.The patient's anatomy was tortuous and was not dilated prior to stent placement.It was reported that the patient's colon tissue was very unstable.The stent was implanted successfully, the occlusion was reported to be resolved, and there were no complications.The patient remained in the hospital for a day or two before being discharged.Four days post stent placement, the patient presented with a moderate fever.Antipyretic medication was given to the patient; however, the patient's fever worsened.On (b)(6) 2021 the patient was sent to the emergency room and imaging was performed.The patient was diagnosed with peritonitis and was sent to palliative surgery urgently to address the peritonitis.The surgeon suspects possible peritonitis caused by perforation of the intestine due to the stent.The patient was reported to be in serious condition in the intensive care unit.Reportedly, on (b)(6) 2021, the patient passed away.It is unknown if there was a relationship between the wallflex colonic stent and the patient's death in the physician's assessment.

• Brand Name: WALLFLEX COLONIC
• Common Device Name: STENT, COLONIC, METALIC, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11766400
• Report Number: 3005099803-2021-01956
• Device Sequence Number: 3661233
• Product Code: MQR
• UDI-Device Identifier: 08714729456582
• UDI-Public: 08714729456582
• Combination Product (Y/N): N
• Initial Reporter Country: UY
• PMA/510(K) Number: K061877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/03/2021

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 Expiration Date: 01/06/2023
• Device Model Number: M00565110
• Device Catalogue Number: 6511
• Device Lot Number: 0026587391
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 05/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention