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

Model Number M00516710

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2015

Event Type  Injury  

Manufacturer Narrative

(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.

Event Description

It was reported to boston scientific corporation on (b)(6) 2015 that a wallflex esophageal fully covered stent was to be used in the lower esophagus during a stent implantation procedure performed on (b)(6) 2015.According to the complainant, this was to treat a stricture due to cancer of the esophagus.Reportedly, the patient's anatomy was not pre dilated.During the procedure, an attempt was made to deploy the stent; however, the white tip of the delivery system detached and fell inside the patient.The fully constrained stent was removed from the patient and the white tip was removed using forceps.The procedure was completed with another wallflex esophageal fully covered stent.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

A wallflex esophageal fully covered stent and delivery system were received for evaluation.Visual examination of the returned device found that the stent was fully constrained on the delivery system with the tip detached.During the product analysis, the investigator noted that cut length of the distal inner shaft was 6mm.Microscopic examination of the distal inner shows evidence that the tip was roughened, and that there is adhesive along the length of the distal inner shaft, and the circumference of the proximal end of the tip shaft.No other issues were identified during the product analysis.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.Device analysis determined that the condition of the returned device was consistent with the complaint incident, the device was received with the tip detached.The noted damage was likely due to procedural or anatomical factors encountered during the procedure such as tortuous anatomy or maneuvering of the device.Therefore, the most probable root cause for this complaint is operational context.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 on (b)(6) 2015 that a wallflex esophageal fully covered stent was to be used in the lower esophagus during a stent implantation procedure performed on (b)(6) 2015.According to the complainant, this was to treat a stricture due to cancer of the esophagus.Reportedly, the patient's anatomy was not pre dilated.During the procedure, an attempt was made to deploy the stent; however, the white tip of the delivery system detached and fell inside the patient.The fully constrained stent was removed from the patient and the white tip was removed using forceps.The procedure was completed with another wallflex esophageal fully covered stent.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: WALLFLEX¿ ESOPHAGEAL
• 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: 5311054
• MDR Text Key: 33881289
• Report Number: 3005099803-2015-03533
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K091510
• 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,Followup
• Report Date: 11/25/2015

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: 06/14/2016
• Device Model Number: M00516710
• Device Catalogue Number: 1671
• Device Lot Number: 17542642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2015
• Initial Date FDA Received: 12/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2014
• 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
• Patient Age: 52 YR
• Patient Weight: 70