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

Model Number M00565060

Device Problem Positioning Problem (3009)

Patient Problems Abdominal Pain (1685); Death (1802); Peritonitis (2252); Bowel Perforation (2668)

Event Date 11/27/2018

Event Type  Death  

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 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
• Type of Device: STENT, COLONIC, METALIC, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8302803
• MDR Text Key: 134928922
• Report Number: 3005099803-2019-00353
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 08714729456537
• UDI-Public: 08714729456537
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K061877
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2019
• Initial Date FDA Received: 02/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention