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 Problem Perforation (2001)

Event Date 05/09/2014

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a wallflex enteral colonic stent was implanted 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 4 cm malignant lesion due to stage iv colonic cancer as palliative care.The patient had cancerous peritonitis and ascites in douglas' pouch prior to stent placement.Reportedly, the patient¿s anatomy was tortuous.No issues were noted during stent implantation.The stent was placed close to the upper rectosigmoid (rs) in the sigmoid colon with the proximal end of the stent placed in the severely tortuous intestinal tract.After stent placement, it was reported that the patient developed ascites in the liver.On (b)(6), 2014, the patient presented with fever and inflammation.An endoscopy and x-ray confirmed that the proximal end of the stent perforated through the bowel wall.The patient was given antibiotics to address the perforation and monitored.The stent remains implanted.The fever and inflammation were relieved with the antibiotics and the patient currently can eat.In the physician¿s assessment, the perforation was likely due to the location of the stent in tortuous anatomy.

Manufacturer Narrative

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'' and ''fever'' are listed within the dfu as potential adverse events.Therefore, the most probable root cause is anticipated procedural complication.  a review of the device history record (dhr) was performed; no anomalies were noted.A search of the complaint database revealed that no other complaints exist for the specified lot.

• 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: 3845631
• MDR Text Key: 17615742
• Report Number: 3005099803-2014-02147
• 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: 05/12/2014

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: 07/12/2015
• Device Model Number: M00565110
• Device Catalogue Number: 6511
• Device Lot Number: 16231091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2014
• Initial Date FDA Received: 06/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2013
• 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: 90 YR