MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRAFLEX ESOPHAGEAL NG; PROSTHESIS, ESOPHAGEAL

Model Number M00513750

Device Problems Use of Device Problem (1670); Material Integrity Problem (2978)

Patient Problem Death (1802)

Event Date 11/01/2018

Event Type  Death  

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Date of event was approximated to (b)(6) 2018 as no specific event date was reported.(b)(4).The complainant indicated that the suspect 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 mdr will be filed.

Event Description

It was reported to boston scientific corporation on november 28, 2018 that an ultraflex esophageal covered distal release stent was implanted to treat a postoperative anastomotic fistula in the esophagus (following total gastrectomy due to cancer) during a gastroscopy with stent placement procedure performed on an unknown date.According to the complainant, post stent placement procedure, a leak of contrast medium in the esophagus was observed on the fluoroscopic images.Reportedly, the physician presumed that there was a breach in the silicone covering of the stent due to spillage.The stent remained implanted, and the patient was under observation.Reportedly, per the physician, there was a failure in the reabsorption of the fistula.Two radiological drainages were positioned to facilitate reabsorption, and a nasogastric tube was attached to the patient.On (b)(6) 2018, boston scientific corporation received a follow-up information that the patient was in a delicate condition and has expired.The patient's death was due to the non-reabsorption of the anastomotic fistula.The correlation between the patient's death and the stent could not be confirmed, as there was a spreading of the contrast medium seen on the x-ray images.Note: according to the complainant, the stent was implanted to treat a postoperative anastomotic fistula in the esophagus (following total gastrectomy).According to the dfu, the ultraflex esophageal ng stent system is contraindicated for "placement in an esophago-jejunostomy (following gastrectomy), as peristalsis may displace stent.".

• Brand Name: ULTRAFLEX ESOPHAGEAL NG
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8190564
• MDR Text Key: 131189430
• Report Number: 3005099803-2018-62175
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729649113
• UDI-Public: 08714729649113
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2020
• Device Model Number: M00513750
• Device Catalogue Number: 1375
• Device Lot Number: 0022765839
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2018
• 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): Death; Required Intervention