MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY ULTRAFLEX? ESOPHAGEAL NG; PROSTHESIS, ESOPHAGEAL

Model Number M00513740

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2014

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an ultraflex esophageal stent was used in the esophagus during a stent placement procedure performed on (b)(6) 2014.According to the complainant, the stent was implanted treat a 4cm malignant stricture due to esophageal cancer.Reportedly, the patient¿s anatomy was slightly tortuous and was not dilated prior to stent placement.During the procedure, the physician attempted to deploy the stent when the stent suture could no longer be released and only 2 cm of the stent was deployed.The partially deployed stent was removed from the patient and 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.

Manufacturer Narrative

(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Manufacturer Narrative

A visual examination of the returned device noted that the distal stent loops were partially deployed.No issues were noted with the profile of the crochet stitches from the point of release from the stent.The dilation tip was bent and dented.During analysis, the investigator retracted the deployment suture and fully deployed the stent without any issue.The noted issue and damage are likely due to procedural or anatomical factors encountered during the procedure such as tortuous anatomy or maneuvering of the device.Therefore, the most probable root cause for this complaint 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.

Event Description

It was reported to boston scientific corporation that an ultraflex esophageal stent was used in the esophagus during a stent placement procedure performed on (b)(6) 2014.According to the complainant, the stent was implanted treat a 4cm malignant stricture due to esophageal cancer.Reportedly, the patient's anatomy was slightly tortuous and was not dilated prior to stent placement.During the procedure, the physician attempted to deploy the stent when the stent suture could no longer be released and only 2 cm of the stent was deployed.The partially deployed stent was removed from the patient and 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.

• Brand Name: ULTRAFLEX? ESOPHAGEAL NG
• Type of Device: PROSTHESIS, ESOPHAGEAL
• 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: 4341964
• MDR Text Key: 5180112
• Report Number: 3005099803-2014-03965
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K091816
• 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: 11/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2016
• Device Model Number: M00513740
• Device Catalogue Number: 1374
• Device Lot Number: 0016676569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2015
• Initial Date FDA Received: 12/18/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2014
• 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 Age: 57 YR
• Patient Weight: 55