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

Model Number M00516700

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Death (1802); Exsanguination (1841); Fistula (1862); Hemorrhage/Bleeding (1888); Vomiting (2144)

Event Date 07/08/2017

Event Type  Death  

Manufacturer Narrative

The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.The physician who implanted the stent was dr.(b)(6).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a wallflex esophageal stent was implanted in a patient to treat a malignant stricture due to esophageal cancer on (b)(6) 2017.According to the complainant, on (b)(6) 2017 the patient was vomiting blood.A ct angiogram was performed and it was determined that it was not an aortic fistula.An egd was then performed to evaluate a gi tract bleed.Upon evaluation of the stricture site, it was noticed that there was an esophageal aortic fistula at the proximal edge of where the stent had been placed.The esophageal aortic fistula was noted to be the site of the ¿gi tract bleed¿.While the physician was inspecting this site, the patient had a massive bleeding event at the fistula that was not able to be controlled and it was decided after family evaluation to not continue with any other therapy.The patient passed away on the same day.In the physicians¿ assessment, the patient¿s cause of death was reported to be exsanguination.The patient did not initially have any abnormal coagulation studies but massive transfusion protocols were initiated.The physician also noted that the patient¿s tissue was probably friable.It is not known whether the erosion that created the esophageal aortic fistula was caused by the stent or the patient¿s disease condition or due to the patient undergoing radiation treatment or a combination of all factors.

Manufacturer Narrative

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 that a wallflex esophageal stent was implanted in a patient to treat a malignant stricture due to esophageal cancer on (b)(6) 2017.According to the complainant, on (b)(6) 2017 the patient was vomiting blood.A ct angiogram was performed and it was determined that it was not an aortic fistula.An egd was then performed to evaluate a gi tract bleed.Upon evaluation of the stricture site, it was noticed that there was an esophageal aortic fistula at the proximal edge of where the stent had been placed.The esophageal aortic fistula was noted to be the site of the ¿gi tract bleed¿.While the physician was inspecting this site, the patient had a massive bleeding event at the fistula that was not able to be controlled and it was decided after family evaluation to not continue with any other therapy.The patient passed away on the same day.In the physicians¿ assessment, the patient¿s cause of death was reported to be exsanguination.The patient did not initially have any abnormal coagulation studies but massive transfusion protocols were initiated.The physician also noted that the patient¿s tissue was probably friable.It is not known whether the erosion that created the esophageal aortic fistula was caused by the stent or the patient¿s disease condition or due to the patient undergoing radiation treatment or a combination of all factors.***additional information received on october 19, 2017: the patient bled several times during their hospitalization.The physician performed an emergent egd in the middle of the night.During the procedure, the physician pushed the stent into the stomach.The stent remained in the patient's stomach when they died.

• Brand Name: WALLFLEX¿ ESOPHAGEAL
• 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: 6768415
• MDR Text Key: 81863702
• Report Number: 3005099803-2017-02263
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M00516700
• Device Catalogue Number: 1670
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 74 YR