MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX ESOPHAGEAL; PROSTHESIS, ESOPHAGEAL

Model Number M00516720

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/25/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2019 that a wallflex esophageal fully covered stent was to be used to treat a tumor in the esophagus during an esophageal stent implantation procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was able to be deployed.Angiography was performed and noticed the stent had migrated during the first implantation.The stent was removed with forceps and 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 following the procedure was reported to be stable.

• Brand Name: WALLFLEX ESOPHAGEAL
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8421820
• MDR Text Key: 138828403
• Report Number: 3005099803-2019-01188
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729778059
• UDI-Public: 08714729778059
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2020
• Device Model Number: M00516720
• Device Catalogue Number: 1672
• Device Lot Number: 22711579
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2018
• 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: 65 YR
• Patient Weight: 62