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

Model Number M00516930

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2016

Event Type  malfunction  

Manufacturer Narrative

The patient's weight is (b)(6).The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.(b)(4).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 on march 19, 2016 that a wallflex¿ esophageal stent was implanted in the esophagus during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2016.According to the complainant, the stent was to be used to treat a malignant stricture caused by cancer in the distal esophagus.Reportedly, the patient¿s anatomy was not tortuous and had not been dilated prior to stent placement procedure.According to the complainant, the wallflex¿ esophageal stent migrated approximately 2cm distally into the stomach.Reportedly, the patient initially felt discomfort and, on (b)(6) 2016, an x-ray was performed and migration was confirmed.On (b)(6) 2016, the patient¿s discomfort subsided and the physician decided to leave the stent in place.There were no patient complications reported as a result of this event.The patient's current condition was reported to be okay.

• 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: 5552241
• MDR Text Key: 42033001
• Report Number: 3005099803-2016-00866
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00516930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2016
• 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): Other
• Patient Age: 80 YR