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

Model Number M00516930

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

Patient Problems Death (1802); Dysphagia/ Odynophagia (1815); Fever (1858); Hemorrhage/Bleeding (1888); Nausea (1970); Internal Organ Perforation (1987)

Event Date 04/28/2015

Event Type  Death  

Event Description

It was reported to boston scientific corporation on (b)(6) 2015 that a partially covered wallflex¿ esophageal stent was implanted in the mid-esophagus during an esophageal stent placement procedure performed on (b)(6) 2015.There were no complications during the procedure and the patient was released from the hospital on (b)(6) 2015.Reportedly, the patient was diagnosed with cancer in 2007 and was treated with cytostatic and chemotherapy and was stable for many years.The patient had undergone cancer treatments (chemotherapy and radiotherapy) multiple times over the past ten years.In the beginning of (b)(6) 2015 the patient experienced symptoms of dysphagia and had trouble eating and drinking.Therefore, the surgeon decided to place a partially covered wallflex¿ esophageal stent to open up the lumen.On (b)(6)2015, the patient went to the emergency room with a feeling of sickness, fever, and dysphagia.The physician noted that the patient experienced heavy bleeding from the mouth/stomach and believes that the stent may have perforated the aorta.The patient expired on (b)(6) 2015 as a result of this event.According to the physician, the patients cancer may have involved the mediastinum and the lungs.In the physician's assessment, the cause of death may have been due to a perforation of the aorta.

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.It was reported the device was not used past its expiry date.The complainant indicated that the device 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.

• Brand Name: WALLFLEX? ESOPHAGEAL
• 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: 4787284
• MDR Text Key: 5815286
• Report Number: 3005099803-2015-01312
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: SE
• PMA/PMN Number: K073266
• 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
• Report Date: 04/29/2015

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?: No
• Device Operator: Health Professional
• Device Model Number: M00516930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/29/2015
• Initial Date FDA Received: 05/21/2015
• 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): Death
• Patient Age: 67 YR