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

Model Number M00516730

Device Problems Occlusion Within Device (1423); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2015

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a fully covered wallflex¿ esophageal stent was implanted in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2015.According to the complainant, the physician attempted to remove the fully covered wallflex¿ esophageal stent during a planned stent removal procedure performed on (b)(6) 2015.During the stent removal procedure, the physician noted that the stent had become occluded due to tissue ingrowth.The physician was unable to remove the fully covered wallflex¿ esophageal stent.A different wallflex¿ esophageal stent was placed inside the previously implanted stent in order to allow the tissue ingrowth to necrose.On (b)(6) 2015, the physician removed the second stent and observed the initial fully covered wallflex¿ esophageal stent.The physician stated that the tissue ingrowth had necrosed and had begun sloughing off.The fully covered wallflex¿ esophageal stent was successfully removed on (b)(6) 2015.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

Manufacturer Narrative

The complainant was unable to provide the device lot number.Therefore, the manufacture and expiration dates are unknown.It was reported the device was not used past its expiry date.(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Manufacturer Narrative

A fully deployed wallflex esophageal fully covered stent was returned for analysis.Visual examination of the returned device noted that the stent had numerous holes smaller than 1.0 mm in diameter in the silicone coating towards the proximal end of the stent, which is within specification for the device.A labeling review was performed and from the information available, this device was used in a manner inconsistent with the labeled indications.The dfu states; ¿warning: stent is considered to be a permanent device.Once stent placement is permanently achieved, stent removal or repositioning is not recommended.¿ the stent was removed from the patient two weeks after the procedure and was returned for analysis.Therefore, the most probable root cause classification is user/use error.

Event Description

It was reported to boston scientific corporation that a fully covered wallflex¿ esophageal stent was implanted in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2015.According to the complainant, the physician attempted to remove the fully covered wallflex¿ esophageal stent during a planned stent removal procedure performed on (b)(6) 2015.During the stent removal procedure, the physician noted that the stent had become occluded due to tissue ingrowth.The physician was unable to remove the fully covered wallflex¿ esophageal stent.A different wallflex¿ esophageal stent was placed inside the previously implanted stent in order to allow the tissue ingrowth to necrose.On (b)(6) 2015, the physician removed the second stent and observed the initial fully covered wallflex¿ esophageal stent.The physician stated that the tissue ingrowth had necrosed and had begun sloughing off.The fully covered wallflex¿ esophageal stent was successfully removed on (b)(6) 2015.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• 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: 4927754
• MDR Text Key: 6010777
• Report Number: 3005099803-2015-02060
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: M00516730
• Device Catalogue Number: 1673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 60 YR