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

Model Number M00565650

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2014

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a wallstent enteral stent was used in the duodenum during a duodenal stent implantation procedure performed on (b)(6) 2014.According to the complainant, the stent was to be used to treat a 6cm lesion with 85% stenosis due to intestinal cancer.Reportedly, the patient's anatomy was mildly tortuous.During the procedure, after reaching the target lesion, the physician attempted to deploy the stent but could not do so.The physician removed the fully constrained stent from the patient.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: this event has been deemed reportable based on the investigation result that the stent was damaged.

Manufacturer Narrative

Investigation result of stent wires damaged.Investigation results.A visual examination showed that the device was received with the stent fully mounted onto the delivery system.During the product analysis the investigator was able to successfully deploy the stent of the device.The distal end of the stent was damaged.It was noted that some of the wires were uncrossed and raised vertically off the stent body.There were several kinks along the length of the inner shaft.This type of damage is consistent with excessive force being applied to the delivery system possibly during attempts to deploy the stent of the device.The investigation concluded that this complaint is associated with a product that meets design and manufacture specifications but due to anatomical/procedural factors encountered during the procedure, performance of the device was limited.Therefore, the most probable root cause classification for the reported failure is operational context.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 labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

• Brand Name: WALLSTENT? ENTERAL ENDOPROSTHESIS
• 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: 4325496
• MDR Text Key: 5247927
• Report Number: 3005099803-2014-03912
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K000281
• 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: 09/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2015
• Device Model Number: M00565650
• Device Catalogue Number: 6565
• Device Lot Number: 16120428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2013
• 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 Age: 57 YR
• Patient Weight: 67