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

Model Number M00516900

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Abdominal Pain (1685); Dysphagia/ Odynophagia (1815)

Event Date 02/11/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation on february 13, 2018 that a wallflex esophageal partially covered stent was implanted to treat a malignant stricture of the distal esophagus during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2018.According to the complainant, on (b)(6) 2018, the patient presented with abdominal pain and increased dysphagia.An esophagogastroduodenoscopy (egd) was performed and showed that the stent had migrated distally in the esophagus.In the physician's assessment, the relationship between the stent placement and the abdominal pain is unknown, but the stent contributed to the patient's dysphagia.The stent was removed from the patient using forceps on (b)(6) 2018.Reportedly, the patient had radiation treatment and chose not to have a new stent implanted.There were no patient complications reported after the stent was explanted.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: 7321529
• MDR Text Key: 101784405
• Report Number: 3005099803-2018-00670
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729765240
• UDI-Public: 08714729765240
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073266
• 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: 02/13/2018

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: 01/02/2020
• Device Model Number: M00516900
• Device Lot Number: 21556722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2018
• Initial Date FDA Received: 03/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2018
• 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: 77 YR