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

Model Number M00514200

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation results: an ultraflex esophageal stent and delivery system was received for analysis.Visual examination of the returned device found the stent partially deployed.A functional analysis noted that it was possible to deploy the stent; the shaft bowed during deployment.The stent retention suture on the proximal end of the stent was found to be missing.No other issues were identified during the product analysis.The investigation confirmed the reported complaint of stent failed to deploy.Taking this into consideration, along with the condition of the returned device, the investigation concluded that the observed failures are likely due to anatomical/ procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause for this complaint is operational context.An investigation has been initiated to address this issue.

Event Description

It was reported to boston scientific corporation that an ultraflex esophageal distal release covered stent was to be used to treat an malignant stricture in the esophagus during a stent implantation procedure performed on (b)(6) 2017.Reportedly, the patient's anatomy was tight.According to the complainant, during the procedure, the stent failed to deploy.The procedure was completed with a different device.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.Note: this event has been deemed an mdr-reportable event based on investigation results which revealed that the stent retention suture of the proximal end of the stent was missing.

• Brand Name: ULTRAFLEX¿ ESOPHAGEAL NG
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6690945
• MDR Text Key: 79291814
• Report Number: 3005099803-2017-01980
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K091816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2019
• Device Model Number: M00514200
• Device Catalogue Number: 1420
• Device Lot Number: 20176641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 55