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

Model Number	M00565060
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Abdominal Pain (1685); Death (1802); Peritonitis (2252); Bowel Perforation (2668)
Date of Event	11/27/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(6).(b)(4).According to the complainant, the suspect device was disposed 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
Note: this report pertains to one of the two devices used during the same procedure.Refer to manufacturer report # 3005099803-2019-00353 and 3005099803-2019-00380 for the associated device.It was reported to boston scientific corporation on january 10, 2019 that two wallflex colonic stents were implanted to treat a 6cm stenosis in the sigmoid and descending colon during a stent placement procedure performed on (b)(6) 2018.According to the complainant, the first 12cm wallflex colonic stent (the subject of this report) was advanced through the endoscope and was deployed; however, the stent "jumped" and was placed not on the stenosis.A second 9cm wallflex colonic stent (the subject of mfr.Report # 3005099803-2019-00380) was implanted in a stent-in-stent placement.Reportedly, on (b)(6) 2018, post stent placement procedure, the patient experienced an abdominal pain.A computed tomography (ct) scan was performed and confirmed intestinal perforation.Reportedly, the perforation site was on the descending colon where the distal end of the 9cm wallflex colonic stent was in placed; however, the relationship between the stent and perforation was unknown.Antibiotic were administered to the patient.On (b)(6) 2018, the patient had expired.Per the physician, peritonitis was the cause of patient's death.Note: on (b)(6) 2019, boston scientific corporation received an additional information that the 9cm stent was a wallflex colonic stent.

• 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: 8302803
• Report Number: 3005099803-2019-00353
• Device Sequence Number: 16409871
• Product Code: MQR
• UDI-Device Identifier: 08714729456537
• UDI-Public: 08714729456537
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/04/2019

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: 09/10/2020
• Device Model Number: M00565060
• Device Catalogue Number: 6506
• Device Lot Number: 0022635673
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 02/04/2019
• 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; Required Intervention