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

Model Number M00516750

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2017

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.Device evaluation anticipated, not yet begun.

Event Description

It was reported to boston scientific corporation on (b)(6) 2017 that a wallflex esophageal fully covered stent was to be used to treat an esophageal stenosis during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the physician was able to deploy the stent but in an incorrect location.The stent was removed from the patient and the procedure was completed with another wallflex esophageal 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 fine.

Manufacturer Narrative

A fully deployed wallflex esophageal fully covered stent and delivery system were returned for analysis.Visual examination of the returned device found that the outer sheath was found kinked in several locations and the green braided polyester suture was inspected and no issues were observed.The stent was measured to be within specifications.The investigation concluded that the observed failures are likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause is operational context.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.A search of the complaint database confirmed that no other similar complaints exist for the specified lot.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) 2017 that a wallflex esophageal fully covered stent was to be used to treat an esophageal stenosis during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the physician was able to deploy the stent but in an incorrect location.The stent was removed from the patient and the procedure was completed with another wallflex esophageal 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 fine.

Event Description

It was reported to boston scientific corporation on (b)(6) 2017 that a wallflex esophageal fully covered stent was to be used to treat an esophageal stenosis during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the physician was able to deploy the stent but in an incorrect location.The stent was removed from the patient and the procedure was completed with another wallflex esophageal 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 fine.

• 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: 7095670
• MDR Text Key: 94124727
• Report Number: 3005099803-2017-03720
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2017

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: 04/02/2019
• Device Model Number: M00516750
• Device Catalogue Number: 1675
• Device Lot Number: 21200175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2017
• Initial Date FDA Received: 12/07/2017
• Supplement Dates Manufacturer Received: 11/16/2017; 12/20/2017
• Supplement Dates FDA Received: 12/12/2017; 01/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2017
• 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