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

Model Number M00565110

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

Patient Problems Death (1802); Perforation (2001)

Event Type  Death  

Event Description

It was reported to boston scientific corporation that a wallflex colonic stent was implanted in the upper rectum to rectosigmoid during a stent placement procedure performed on unknown date.According to the complainant, the stent was implanted as a palliative treatment of a malignant stricture.Reportedly, the patient has stage iv cancer with lung and hepatic metastasis and had avastin chemotherapy after stent implantation.One month post-procedure, it was noted that the patient had a perforation and febrile neutropenia.The perforation occurred at the stent implantation site.Reportedly, the patient died.According to the physician¿s assessment, it is unknown what caused the patient¿s death and whether the stent contributed to the patient¿s 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 report the lot number; therefore the manufacture date and expiration date are unknown.However, the complainant stated that the device was used prior to the expiration date.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.

• Brand Name: WALLFLEX? COLONIC
• Type of Device: STENT, COLONIC, METALIC, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 4305632
• MDR Text Key: 5058620
• Report Number: 3005099803-2014-03846
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Date Manufacturer Received: 11/14/2014
• 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