MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MOD M00565010; STENT,METALLIC,EXPANDABLE,DUODENAL

Model Number UNK476

Device Problem Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a wallflex enteral duodenal stent was implanted during a colonic stent placement procedure on an unknown date.Reportedly, it was unknown if the patient anatomy was tortuous.According to the complainant, the stent got occluded.It was confirmed that there was no tissue ingrowth.The procedure was completed with this device.There were no patient complications as a result of this event.

Manufacturer Narrative

The complainant was unable to report the upn and lot number; therefore, the manufacture date and expiration date are unknown.Reported event of stent occluded.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 there was no evidence that the device was used in a manner inconsistent with the labelled indications.Obstruction is listed in the dfu for this product as a potential adverse event.Therefore, the most probable root cause is anticipated procedural complication.

• Brand Name: WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MOD M00565010
• Type of Device: STENT,METALLIC,EXPANDABLE,DUODENAL
• 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: 3852971
• MDR Text Key: 4654805
• Report Number: 3005099803-2014-02199
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• PMA/PMN Number: K062750
• 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: 05/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK476
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2014
• 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 Age: 53 YR