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

Model Number	M00516910
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Pain (1994)
Date of Event	01/03/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8296801
• Report Number: 3005099803-2019-00232
• Device Sequence Number: 16679473
• Product Code: ESW
• UDI-Device Identifier: 08714729765257
• UDI-Public: 08714729765257
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K073266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/01/2019

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
• Operator of Device: Health Professional
• Device Model Number: M00516910
• Device Catalogue Number: 56453
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 02/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR