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

Model Number M00516730

Device Problem Migration (4003)

Patient Problem No Code Available (3191)

Event Date 09/17/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complainant indicated that the device remains implanted 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) 2020 that a wallflex esophageal fully covered stent was implanted to treat a 3cm malignant stricture in the esophagus during an esophagogastroduodenoscopy (egd) with stent placement performed on (b)(6) 2020.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.According to the complainant, two days after the stent placement during a routine follow-up procedure, a nasogastric tube was placed and it was noted under kidney, ureter, bladder (kub) imaging that the stent had migrated.On (b)(6) 2020, an egd procedure was performed and the stent was repositioned with rat tooth forceps and sutured in place.The stent remains implanted and the procedure was completed with original 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 CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 10652751
• MDR Text Key: 210570765
• Report Number: 3005099803-2020-04507
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729778066
• UDI-Public: 08714729778066
• 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
• Report Date: 10/08/2020

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: 12/02/2021
• Device Model Number: M00516730
• Device Catalogue Number: 1673
• Device Lot Number: 0025557094
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 10/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2020
• 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: 70 YR
• Patient Weight: 47