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 Problem Perforation (2001)

Event Date 11/04/2014

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a wallflex colonic stent was used in the sigmoid colon during a stent placement procedure performed on (b)(6) 2014.According to the complainant, the stent was implanted to treat a 3 cm malignant stricture and to improve ileus due to colon cancer.Reportedly, the patient¿s anatomy was tortuous.There were no issues noted during stent implantation.On (b)(6) 2014 enema examination was performed and no issues were noted to the stent.On (b)(6) 2014 colonoscopy of the entire large bowel was performed to check the distal part of the stent prior to extirpative surgery but the scope was unable to cross the stent, the check was discontinued but no issued were noted to the stent.On (b)(6) 2014, an extirpative surgery of colon cancer was performed and the stent and tumor were removed from the patient.After the procedure, the physician was checking the removed tissue and noted that the flare of the distal stent had perforated the large intestine mucosa.According to the physician, the perforation was due to the severe bending of the anatomy, which caused the flare of the stent to come in contact with the intestinal wall.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.

Manufacturer Narrative

The complainant was unable to report the upn and 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 device was not returned; therefore, a technical analysis could not be performed.A labeling review was performed, and from the information available this device was used per the directions for use (dfu) / product label.  ''perforation'' is listed within the dfu as potential adverse event.Therefore, the most probable root cause is anticipated procedural complication  .

• 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: 4342008
• MDR Text Key: 5197996
• Report Number: 3005099803-2014-03964
• 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: 11/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M00565100
• Device Catalogue Number: 6510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2014
• 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
• Patient Age: 65 YR