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

Model Number M00513740

Device Problem Activation Failure (3270)

Patient Problems Arrhythmia (1721); Aspiration/Inhalation (1725); Death (1802)

Event Date 08/09/2014

Event Type  Death  

Event Description

It was reported to boston scientific corporation that an ultraflex esophageal distal release stent was implanted in the esophagus during an esophageal stenting procedure performed on (b)(6) 2014.According to the complainant, the stent was implanted to treat a tracheoesophageal fistula caused by disseminated esophageal cancer.Reportedly, the stricture was dilated prior to procedure.During the procedure the physician implanted the stent without issue.On (b)(6) 2014, x-ray was performed and the physician noted that the proximal end of the stent had not fully expanded.The physician performed a dye study on (b)(6) 2014, however during the dye study the patient aspirated the dye through the fistula.The patient went into to cardiac arrest due to the aspiration on (b)(6) 2014 and the patient died on (b)(6) 2014.According to the physician, the cause of death was aspiration pneumonia and cardiac arrest.In the physician¿s assessment, the patient aspirated the dye because the stent had not fully expanded to close the fistula and the aspiration led to the cardiac arrest and death.

Manufacturer Narrative

(b)(4) stent failure 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.

• Brand Name: ULTRAFLEX? ESOPHAGEAL NG
• 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: 4064907
• MDR Text Key: 4814531
• Report Number: 3005099803-2014-02975
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K091816
• 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: 08/14/2014

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: 01/19/2016
• Device Model Number: M00513740
• Device Catalogue Number: 1374
• Device Lot Number: 0016671628
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2014
• Initial Date FDA Received: 09/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2014
• 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): Death
• Patient Age: 52 YR