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 Perforation (2001); Peritonitis (2252)

Event Date 08/06/2014

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a wallflex enteral colonic stent was implanted in the transverse colon during a gastrointestinal stent implantation procedure performed on (b)(6) 2014.According to the complainant, the stent was implanted to treat a 10 mm malignant stricture in the straight line from the transverse colon.Reportedly, the patient had peritoneal dissemination and adhesion in the large intestine prior to the procedure.On (b)(6) 2014, the physician reported that patient experienced symptoms of peritonitis, a ct scan was performed and it was noted that the mucosa in the lesion was perforated.The perforation was located near where the stent had expanded in the stricture.Reportedly, the stent remains implanted and the patient was abstaining from food.In the physician¿s assessment, the perforation was due to the strong radial expansion of the stent.The physician reported that a perforation likely would have occurred with any stent implantation due to the patient¿s peritoneal dissemination and adhesion of large intestine.The patient has not started eating food yet and is currently under observation.The patient¿s condition at the conclusion of the procedure was reported to be fine.

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: ingrid matte ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 4039763
• MDR Text Key: 4806275
• Report Number: 3005099803-2014-02921
• 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: 08/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• 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: 08/06/2014
• 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): Other