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	Abdominal Pain (1685); Death (1802); Perforation (2001)
Date of Event	05/28/2019
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.The complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.(b)(6).(b)(4).The complainant indicated that the device 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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2019 that a wallflex colonic stent has been implanted in the sigmoid colon to treat colon cancer during a gastrointestinal stent placement procedure performed on (b)(6) 2019.According to the complainant, several hours after the stent placement procedure, the patient experienced abdominal pain.It was later confirmed that a perforation occurred.It is unknown whether the perforation was treated.The patient eventually passed away.Reportedly, the patient was in poor condition so the cause of the perforation and the patient's death could not be determined.

• 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: 8723695
• Report Number: 3005099803-2019-03133
• Device Sequence Number: 19253600
• Product Code: MQR
• UDI-Device Identifier: 08714729456582
• UDI-Public: 08714729456582
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K061877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00565110
• Device Catalogue Number: 6511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 06/21/2019
• 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