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

Model Number UNK477

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

Patient Problem Low Oxygen Saturation (2477)

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a wallflex esophageal stent was implanted during a stent placement procedure in the distal part of the esophagus on an unknown date.According to the complainant, the patient¿s anatomy was not tortuous and had not been dilated prior to the stent placement.Reportedly, the patient had undergone gastric bypass surgery (exact date unknown), which resulted in a leak.The physician performed two surgeries to resolve the leak (dates unknown) but was unsuccessful.The wallflex esophageal stent was implanted to close the leak without any issues.Four weeks post procedure, on (b)(6), 2013, the physician noted a fistula above the implanted stent.The physician removed the stent using rat tooth forceps and another wallflex esophageal stent was placed to cover the fistula.During the stent removal, the patient experienced oxygen desaturation.According the physician, the stent did not cause or contribute to the fistula.No intervention was performed to resolve the desaturation, the patient was given rest and referred to another hospital.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Pt age: although the exact patient age was not provided, the patient was reported to be over 18 years of age.Additional device info: the complainant was unable to provide the suspect device lot number; therefore, the device expiration date and device manufacture date are unknown.However, it was reported that the device was not used past the expiration date.The complainant indicated that the device was disposed 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: 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: ingrid matte ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 3557309
• MDR Text Key: 4073532
• Report Number: 3005099803-2014-00094
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091510
• 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: 12/13/2013

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: UNK477
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2013
• Initial Date FDA Received: 01/07/2014
• 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