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

Model Number M00513750

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2014

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an ultraflex esophageal stent was implanted in the esophagus during a stent placement procedure performed on (b)(6) 2014.According to the complainant, the stent was implanted to treat an 11 cm malignant lower esophageal stricture.Reportedly, the patient¿s anatomy was not tortuous and was dilated using a savary gillard dilator.During the procedure, the physician began deploying the stent when resistance was felt.The physician moved the delivery system proximally by 3 cm when the deployment suture started to release.The physician pushed the catheter back to its original position but the deployment suture got stuck again.The stent was then pulled proximally and was deployed.The stent was not placed in its intended location and another stent was placed overlapping with the first stent to cover the distal end of the stricture.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 stable.

Manufacturer Narrative

(b)(4) stent positioning issue.The device has not been received for analysis.Upon receipt and 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 visual examination found that only the delivery catheter was returned.No issues were noted with the profile of the shaft.Given the event description and condition of the returned device, difficulty was experienced during deployment and was likely due to anatomical or procedural factors such as tortuous anatomy or maneuvering of the device.Therefore, a review and analysis of all available information indicated that the most probable root cause is operational context.A review of the device history record (dhr) was performed; no anomalies were noted.A labeling review was performed, and from the information available this device was used per the directions for use (dfu) / product label.

Event Description

It was reported to boston scientific corporation that an ultraflex esophageal stent was implanted in the esophagus during a stent placement procedure performed on (b)(6) 2014.According to the complainant, the stent was implanted to treat an 11 cm malignant lower esophageal stricture.Reportedly, the patient's anatomy was not tortuous and was dilated using a savvary gillard dilator.During the procedure, the physician began deploying the stent when resistance was felt.The physician moved the delivery system proximally by 3 cm when the deployment suture started to release.The physician pushed the catheter back to its original position but the deployment suture got stuck again.The stent was then pulled proximally and was deployed.The stent was not placed in its intended location and another stent was placed overlapping with the first stent to cover the distal end of the stricture.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 stable.

• Brand Name: ULTRAFLEX? ESOPHAGEAL NG
• 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: 4291788
• MDR Text Key: 21721080
• Report Number: 3005099803-2014-03819
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K091816
• 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: 11/10/2014

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: 07/16/2015
• Device Model Number: M00513750
• Device Catalogue Number: 1375
• Device Lot Number: 0016238193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2015
• Initial Date FDA Received: 12/02/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2013
• 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: 55 YR