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

Model Number M00516740

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/12/2014

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a wallflex esophageal stent was implanted during a stent placement procedure performed on an (b)(6) 2014.According to the complainant, the stent was implanted to treat a leak due to boerhaave¿s syndrome and a food impaction that required an esophageal repair.No issues were noted during stent implantation.Reportedly, a month after stent implantation, the patient was no better.On (b)(6) 2014, the physician removed the stent.The physician noted two small holes adjacent to each other in the stent cover.Another wallflex esophageal stent was implanted to complete the procedure.Despite numerous attempts boston scientific has been unable obtain additional information regarding the circumstances surrounding this event.Should additional relevant details become available a supplemental report will be submitted.

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.(b)(4) for the reported event of stent cover damaged.The device was not returned; therefore, a technical analysis could not be performed.A labeling review was performed, and from the information available this device was used in a manner inconsistent with the labelled indications.The dfu states ''the wallflex esophageal fully covered stent system is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.Warning: stent is considered to be a permanent device.Once stent placement is permanently achieved, stent removal or repositioning is not recommended.'' the physician used the device for leak in an esophageal repair and was removed and replaced the stent with another wallflex stent.Therefore, the most probable root cause is user/ use error.  a review of the device history record (dhr) was performed; no anomalies were noted.A search of the complaint database revealed that no similar complaints exist for the specified lot.

• 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: 3851651
• MDR Text Key: 16084295
• Report Number: 3005099803-2014-02180
• 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: 05/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2015
• Device Model Number: M00516740
• Device Catalogue Number: 1674
• Device Lot Number: 16822786
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2014
• 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): Required Intervention