MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX¿ COLONIC; STENT, COLONIC, METALIC, EXPANDABLE

Model Number M00565100

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

Patient Problems Inflammation (1932); Perforation (2001)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complainant indicated that the device remains implanted 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

It was reported to boston scientific corporation on november 09, 2015 that a wallflex enteral colonic stent was implanted for palliative treatment of a 3 cm malignant stricture in the colon during a colonic stent placement procedure performed on (b)(6) 2015.Reportedly, the patient's anatomy was not tortuous.According to the complainant, the patient presented with abdominal pain approximately one month post stent placement procedure.The patient underwent a computed tomography (ct) scan which revealed free air in the abdominal cavity confirming a perforation.The free air was not concentrated on the site where the wallflex enteral colonic stent was implanted.In the physician's assessment, the stent may have contributed to the perforation.According to the physician, the patient developed peritonitis.Since the patient's colorectal cancer is terminal, the physician believed that the patient's condition was not solely caused by peritonitis.The patient currently receives home therapy and is under medication for pain control.The wallflex enteral colonic stent was left implanted inside the patient.

• Brand Name: WALLFLEX¿ COLONIC
• Type of Device: STENT, COLONIC, METALIC, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5258849
• MDR Text Key: 32450302
• Report Number: 3005099803-2015-03408
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• 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: 11/09/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/05/2017
• Device Model Number: M00565100
• Device Catalogue Number: 6510
• Device Lot Number: 0018268023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2015
• Initial Date FDA Received: 12/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2015
• 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
• Patient Age: 80 YR