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

Model Number UNK448

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

Patient Problems Death (1802); Asphyxia (1851); Hemorrhage/Bleeding (1888); Respiratory Failure (2484)

Event Type  Death  

Event Description

It was reported to boston scientific corporation that an ultraflex esophageal stent was implanted in the esophagus during an esophageal stent implantation procedure performed on (b)(6) 2014.Reportedly, the patient had undergone radiation for esophageal cancer.According to the complainant, the stent was implanted to treat an esophagobronchial fistula that developed while the patient was undergoing radiation.During the procedure, the physician implanted the stent without issue.However, several days post procedure in (b)(6) 2014 (exact date unknown), the patient vomited blood.Emergency medical personnel noted that the patient was in cardio-respiratory arrest and attempted cardiopulmonary resuscitation, however it was unsuccessful and the patient died.According to the physician, the exact cause of death was unknown but in the physician¿s assessment the vomiting of blood caused asphyxia resulting in death.The physician alleged the bleeding could have been caused by end stage esophageal cancer or possibly the stent but the exact cause was unknown.According to the physician, the relationship between the vomiting of blood, the patient¿s death and the stent was unknown.Additional information received on march 18, 2015.According to the complainant, it was confirmed that the stent implanted inside the patient was an ultraflex esophageal covered stent.

Event Description

It was reported to boston scientific corporation that an ultraflex esophageal stent was implanted in the esophagus during an esophageal stent implantation procedure performed on (b)(6) 2014.Reportedly, the patient had undergone radiation for esophageal cancer.According to the complainant, the stent was implanted to treat an esophagobronchial fistula that developed while the patient was undergoing radiation.During the procedure, the physician implanted the stent without issue.However, several days post procedure in (b)(6) 2014 (exact date unknown), the patient vomited blood.Emergency medical personnel noted that the patient was in cardio-respiratory arrest and attempted cardiopulmonary resuscitation, however it was unsuccessful and the patient died.According to the physician, the exact cause of death was unknown but in the physician¿s assessment the vomiting of blood caused asphyxia resulting in death.The physician alleged the bleeding could have been caused by end stage esophageal cancer or possibly the stent but the exact cause was unknown.According to the physician, the relationship between the vomiting of blood, the patient¿s death and the stent was unknown.

Manufacturer Narrative

The complainant was unable to report the upn and lot number; therefore, the manufacture date and expiration date are unknown.The complainant indicated that the device remained 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
• 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: 4028155
• MDR Text Key: 18924861
• Report Number: 3005099803-2014-02866
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• PMA/PMN Number: K955347
• 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,Followup
• Report Date: 07/31/2014

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?: No
• Device Operator: Health Professional
• Device Model Number: UNK448
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2015
• Initial Date FDA Received: 08/21/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/07/2015
• 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: 80 YR