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

Model Number M00516250

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2017 that a wallflex¿ esophageal fully covered rmv stent was implanted to treat a 3 to 4 cm malignant stricture in the cardia during a stent placement procedure performed in (b)(6) 2017.Reportedly, the patient's anatomy was narrow.According to the complainant, during the procedure, the surgeon had difficulty releasing the stent.The stent was deployed in an incorrect location and was noted to have migrated proximal to the intended location.The physician removed the stent with a grasping forceps 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 stable.

Manufacturer Narrative

A fully deployed wallflex esophageal fully covered rmv delivery system was received for analysis, the stent was not returned.Visual analysis found the outer sheath was kinked and the inner shaft was curved at distal end.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.The damages noted with the device were consistent with the application of excessive force during attempted deployment.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) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A search of the complaint database confirmed that no other similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation on (b)(6) 2017 that a wallflex esophageal fully covered rmv stent was implanted to treat a 3 to 4 cm malignant stricture in the cardia during a stent placement procedure performed in (b)(6) 2017.Reportedly, the patient's anatomy was narrow.According to the complainant, during the procedure, the surgeon had difficulty releasing the stent.The stent was deployed in an incorrect location and was noted to have migrated proximal to the intended location.The physician removed the stent with a grasping forceps 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 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: 7148495
• MDR Text Key: 95842305
• Report Number: 3005099803-2017-03797
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: SE
• PMA/PMN Number: SIMILAR
• 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: 12/06/2017

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: 09/12/2018
• Device Model Number: M00516250
• Device Catalogue Number: 1625
• Device Lot Number: 20400112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 12/27/2017
• Supplement Dates Manufacturer Received: 01/05/2018
• Supplement Dates FDA Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2017
• 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