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

Model Number M00513710

Device Problem Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4) for the reported event of stent failed to expand.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 december 02, 2015, that an ultraflex esophageal ng distal release 18x10 uncovered stent was implanted from the esophagus to the gastric cardia during an esophageal stenting procedure performed on (b)(6) 2015.According to the complainant, this was to treat a stricture due to stomach and esophageal cancer.Reportedly.The patient's anatomy was not tortuous and was not pre dilated.During the procedure, the guidewire was positioned in the stomach and the scope was removed from the patient.The ultraflex esophageal ng distal release 18x10 uncovered stent was delivered to the target area via a guidewire the stent was implanted without issues.However, under the fluoroscopy, it was confirmed that the proximal end of the stent was not fully expanded.An ultraflex esophageal ng proximal release 18x7 uncovered stent was then implanted within the first stent to complete 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 good.

• 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: 5321005
• MDR Text Key: 34196810
• Report Number: 3005099803-2015-03653
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• 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: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2017
• Device Model Number: M00513710
• Device Catalogue Number: 1371
• Device Lot Number: 17942402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2015
• Initial Date FDA Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2015
• 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