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

Model Number M00565050

Device Problem Positioning Problem (3009)

Patient Problem Bowel Perforation (2668)

Event Date 11/01/2021

Event Type  Death  

Manufacturer Narrative

Approximated based on the date the manufacturer became aware of the event.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device remains implanted and will not be returned for evaluation; therefore, a problem 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 two devices used during the same procedure.Refer to manufacturer report # 3005099803-2021-06238 and 3005099803-2021-06239 for the associated device information.It was reported to boston scientific corporation on november 12, 2021 that a wallflex enteral colonic stent was implanted to treat an approximately 3cm malignant recto-sigmoid stricture during a stent placement procedure performed on (b)(6) 2021.During the stent placement procedure, a 9cm wallflex enteral colonic stent (the subject of this report) was deployed in the incorrect position so a 12cm wallflex enteral colonic stent (the subject of mfr.# 3005099803-2021-06239) was also placed to fully bridge the stricture.A week after the stent placement procedure, the patient underwent chemotherapy; however, after a few days, symptoms of perforation were noted.It was confirmed that the patient's bowel had perforated at the implant site.The patient was treated with critical care for the perforation but the patient passed away.In the physician's assessment, the relationship between the stents and the perforation/death is unknown.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12912990
• MDR Text Key: 281549220
• Report Number: 3005099803-2021-06238
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 08714729456520
• UDI-Public: 08714729456520
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K061877
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: M00565050
• Device Catalogue Number: 6505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2021
• Initial Date FDA Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention; Hospitalization; Death