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

Model Number M00516730

Device Problems Break (1069); Migration or Expulsion of Device (1395); Material Integrity Problem (2978)

Patient Problems Dysphagia/ Odynophagia (1815); Stenosis (2263)

Event Date 01/31/2014

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was implanted during an esophageal dilatation and stent implantation procedure performed on (b)(6), 2013.According to the complainant, the stent was placed to treat a non-malignant esophageal stenosis 0-5cm above the esophago-gastric junction.Reportedly, the patient¿s anatomy was not tortuous and had not been dilated prior to the procedure.On (b)(6), 2014, the patient experienced dysphagia due to recurrent stenosis in the esophagus.The physician noted that the stent had migrated into the stomach.The stent was removed from the patient.The physician performed a dilation of the stenosis to complete the procedure.The patient condition at the conclusion of the procedure was reported stable.

Manufacturer Narrative

(b)(4).A visual examination of the returned device noted that only a deployed stent was returned for analysis.The stent wires at the flared end were broken and the stent cover was torn.A hole greater than 1.0mm in diameter was noted at the non-flared end.The complainant reported that this device was used to treat a nonmalignant esophageal stenosis.The wallflex esophageal fully covered stent system dfu states that it is contraindicated for placement in esophageal strictures by benign tumors.Therefore, the most probable root cause classification 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.

Manufacturer Narrative

Returned for analysis was a deployed stent only.The stent wires at the flared end were broken and the stent cover was torn also.A hole was noted at the nonflared end that was greater than 1.0mm in diameter.No other issues noted.The investigation concluded that the complaint is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.  therefore, the most probable root cause classification for the reported failure is anticipated procedural complication.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.Labeling review indicates that there was evidence that the device was used in a manner inconsistent with the labelled indications.The wallflex esophageal fully covered stent system is contraindicated for placement in esophageal strictures caused by benign tumors, as the long-term effects of the stent in the esophagus are unknown.This stent was used to treat a nonmalignant esophageal stenosis.

Event Description

It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was implanted during an esophageal dilatation and stent implantation procedure performed on (b)(6) 2013.According to the complainant, the stent was placed to treat a non-malignant esophageal stenosis 0-5cm above the esophago-gastric junction.Reportedly, the patient's anatomy was not tortuous and had not been dilated prior to the procedure.On (b)(6) 2014, the patient experienced dysphagia due to recurrent stenosis in the esophagus.The physician noted that the stent had migrated into the stomach.The stent was removed from the patient.The physician performed a dilation of the stenosis to complete the procedure.The patient condition at the conclusion of the procedure was reported stable.

• 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: 3769746
• MDR Text Key: 4430954
• Report Number: 3005099803-2014-01719
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K091510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/17/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2015
• Device Model Number: M00516730
• Device Catalogue Number: 1673
• Device Lot Number: 0016398141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2014
• Initial Date FDA Received: 04/24/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2013
• 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: 65 YR