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); Hemorrhage/Bleeding (1888); Tissue Damage (2104)

Event Date 10/12/2014

Event Type  Death  

Event Description

It was reported to boston scientific corporation that a wallflex esophageal stent was implanted in the esophagus during an esophageal stent placement procedure performed on (b)(6) 2014.According to the complainant, the stent was implanted to treat an extrinsic compression of the esophagus due to malignancy.The physician suspected a 3rd reoccurrence of breast cancer.During the procedure, the stent was implanted without issue.The next day, the patient reported pain without required intervention/treatment reported to address the pain.In early october (exact date unknown), the patient underwent chemotherapy treatment.On (b)(6) 2014, the patient presented to the er and an upper endoscopy was performed wherein possible bleeding was observed.Reportedly, a day or two later, a second endoscopy was performed wherein the patient lost an estimated 8 units of blood.The patient exsanguinated the following day.The cause of death was not reported.According to the physician, preliminary autopsy results noted that the stent had eroded into the esophagus.Boston scientific has been unable obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available a supplemental report will be submitted.

Manufacturer Narrative

A visual and functional examination of the complaint device could not be performed because the device was not returned for analysis.A labeling review was performed, and from the information available this device was used per the directions for use (dfu) / product label. ''death'', ''pain'' and ''bleeding'' are listed in the dfu for this product as a potential post stent placement complication related to the use of this device.Therefore, the most probable root cause is anticipated procedural complication.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications.A search of the complaint database revealed that no other complaints exist for the specified lot.A labeling review was performed, and from the information available this device was used per the directions for use (dfu) / product label.

• 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: 4291784
• MDR Text Key: 5053664
• Report Number: 3005099803-2014-03812
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073266
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/05/2014

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: Physician
• Device Expiration Date: 08/10/2016
• Device Model Number: M00516930
• Device Lot Number: 0017188483
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2014
• Initial Date FDA Received: 12/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2014
• 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: 70 YR