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

Model Number M00565050

Device Problem Activation Failure (3270)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/22/2015

Event Type  Injury  

Event Description

It was reported to boston scientific corporation on (b)(4) 2015 that a wallflex enteral colonic 9cm stent was implanted during a colonic stenting procedure performed on (b)(6) 2015.The device was placed on the target site and the stent had not fully expanded after initial placement due to the tight stricture.The patient had no complaints after the procedure and was discharged the next day.On (b)(6) 2015, the patient came back with an unspecified complaint.X-ray and direct visualization colonoscopy revealed that the stent had still not fully expanded.A wallflex enteral colonic 12cm stent was implanted within the unexpanded stent to complete the procedure.The patient was reported to be doing fine after the procedure.Despite numerous attempts boston scientific has been unable obtain additional information regarding the circumstances surrounding this event.Should additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.(b)(4).Investigation results: a visual and functional examination of the complaint device could not be performed since the device was not returned for analysis.The most probable root cause classification of this investigation is anticipated procedural complication.This is defined as a complaint that is due to a known physiological effect of the procedure noted within the directions for use (dfu), and/or device labeling.Inadequate expansion is listed in the dfu as a potential adverse event.A search of the complaint database confirmed that no other complaints exist for the specified batch.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu)/product label.

• 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: 4770668
• MDR Text Key: 19497103
• Report Number: 3005099803-2015-01333
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 04/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2016
• Device Model Number: M00565050
• Device Catalogue Number: 6505
• Device Lot Number: 0016663821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2014
• 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