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

Model Number M00565050

Device Problem Positioning Problem (3009)

Patient Problem Perforation (2001)

Event Date 01/24/2014

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a wallflex enteral colonic stent was implanted during a colonic stenting procedure performed on (b)(6) 2014.According to the complainant, the stent placement is a bridge-to-surgery stenting due to a total bowel obstruction and to treat an acute 2.5cm stricture within the sigmoid colon.Reportedly, the patient¿s anatomy was tortuous.On the evening of (b)(6) before midnight, the stent was able to be deployed to the patient without issue.Few hours after stent placement, on (b)(6) 2014, the physician performed an x-ray to the patient and was found out that the stent seemed to be on the bad position.A free gas in the peritoneum was noted and a perforation at the proximal side of the stricture, where the proximal end part of the stent had been located.The physician performed laparotomy procedure and immediately converted into a hartman surgery.A temporary stoma was placed on the patient and is planned to be reconstructed to an anastomosis.The stent was removed from the patient during the surgical procedure.In the physician¿s assessment, the stent was placed in a curved sigmoideum anatomy and in the 4cm healthy lumen that could have caused the perforation.There was no alleged malfunction of the stent.The patient was reported to have recovered well and was discharged from the hospital in stable condition.

Manufacturer Narrative

Reported event of stent positioning/placement problem.Investigation results.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 as a potential adverse event in the dfu for this product as a potential post stent placement complications related to the use of this device.Therefore, the most probable root cause is anticipated procedural complication.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A search of the complaint database confirmed that no similar complaints exist for the specified batch.

• 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: 3656610
• MDR Text Key: 19022640
• Report Number: 3005099803-2014-01284
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: SE
• 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: 02/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: M00565050
• Device Catalogue Number: 6505
• Device Lot Number: 15066940
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2012
• 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
• Patient Age: 55 YR