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 08/23/2014

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.The stent was implanted to relieve an ileus of the colon.According to the complainant, the patient¿s anatomy was tortuous.There were no issues during stent placement.Reportedly, the patient complained of abdominal pain post-procedure.On (b)(6) 2014, the patient complained again of abdominal pain and it was reported that a perforation was observed in the sigmoid colon.The patient underwent an emergency surgery and a stoma was made.In the physician¿s assessment, the surgery was due to the perforation, which was possibly caused by the non-bsc guidewire.However, bsc was unable to obtain confirmation of the physician¿s assessment of the relationship between the stent and the perforation.On (b)(6) 2014, it was reported that the patient¿s condition was not good.However, additional follow up on (b)(6) 2014 noted that the patient¿s condition is now stable.

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 was disposed 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.

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 ''pain (e.G.Discomfort, foreign body sensation)'' are listed in the dfu for this product as a potential post stent placement complication related to the use of this device.Therefore, the most probable root cause is anticipated procedural complication.

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.The stent was implanted to relieve an ileus of the colon.According to the complainant, the patient's anatomy was tortuous.There were no issues during stent placement.Reportedly, the patient complained of abdominal pain post-procedure.On (b)(6) 2014, the patient complained again of abdominal pain and it was reported that a perforation was observed in the sigmoid colon.The patient underwent an emergency surgery and a stoma was made.In the physician's assessment, the surgery was due to the perforation which was possibly caused by the non-bsc guidewire.However, bsc was unable to obtain confirmation of the physician's assessment of the relationship between the stent and the perforation.On (b)(6) 2014, it was reported that the patient's condition was not good.However, additional follow up on (b)(6) 2014 noted that the patient's condition is now stable.Additional information received on (b)(6) 2014.The stent was removed during the emergency surgery on (b)(6) 2014.

• 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: 4093772
• MDR Text Key: 17994252
• Report Number: 3005099803-2014-03130
• 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,Followup
• Report Date: 08/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2014
• 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: 09/17/2014
• 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): Required Intervention