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

Model Number M00513820

Device Problems Partial Blockage (1065); Break (1069); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complainant indicated that the device remains implanted and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on october 05, 2015 that an uncovered ultraflex esophageal ng stent was implanted during a stent placement procedure performed on (b)(6) 2015.According to the complainant, the stent was implanted to treat a 5mm benign fistula in the proximal esophagus caused by stomach cancer.Reportedly, the patient's anatomy was not tortuous and had not been dilated prior to stent placement.The stent was successfully implanted without issue.On (b)(6) 2015, during a planned stent removal, the physician attempted to remove the stent using a foreign body gripper; however, the stent retention suture broke and the stent was unable to be removed.The physician noted that the difficulty removing the stent was probably due to some noted tissue ingrowth within the stent.On (b)(6) 2015, the physician deployed a wallflex esophageal stent within the previously implanted stent, completing the procedure.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 okay.Please note, the uncovered ultraflex esophageal ng stent was not used per the directions for use (dfu).The uncovered ultraflex esophageal ng stent was used to cover a benign fistula and the ultraflex esophageal ng stent system dfu notes the stent is contraindicated for "placement for occlusion of esophageal fistula of any type, unless a covered stent is being used.".

• Brand Name: ULTRAFLEX¿ ESOPHAGEAL NG
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5185283
• MDR Text Key: 29775251
• Report Number: 3005099803-2015-02993
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: K091816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: M00513820
• Device Catalogue Number: 1382
• Device Lot Number: 17522774
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2014
• 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
• Patient Age: 53 YR