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

Model Number M00516910

Device Problem Positioning Problem (3009)

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994)

Event Date 01/03/2019

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration date and device manufacture date are unknown.According to the complainant, the suspect device has been 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 mdr will be filed.

Event Description

It was reported to boston scientific corporation on january 7, 2019 that a wallflex esophageal partially covered stent was implanted to treat a 6 cm malignant stricture in the gastroesophageal junction during a stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's distal esophagus was tortuous.According to the complainant, the patient presented back on (b)(6) 2019 with pain from the stent.The physician repositioned the stent to help eliminate dysphagia and pain.On (b)(6) 2019, the stent was removed from the patient during an esophagogastroduodenoscopy procedure.Reportedly, dysphagia and pain were considered resolved.The patient's condition following the procedure was reported to be fine.Reportedly, the patient will continue the chemotherapy per protocol.

• 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: 8296801
• MDR Text Key: 134728811
• Report Number: 3005099803-2019-00232
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729765257
• UDI-Public: 08714729765257
• 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: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00516910
• Device Catalogue Number: 56453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 76 YR