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

Model Number M00565110

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Death (1802); Perforation (2001)

Event Date 05/28/2019

Event Type  Death  

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 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
• 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: 8723695
• MDR Text Key: 148819727
• Report Number: 3005099803-2019-03133
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 08714729456582
• UDI-Public: 08714729456582
• 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: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00565110
• Device Catalogue Number: 6511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2019
• Initial Date FDA Received: 06/21/2019
• 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): Death