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

Model Number	M00516940
Medical Device Problem Codes	Material Deformation (2976); Migration (4003)
Health Effect - Clinical Codes	Erosion (1750); Pain (1994); Perforation (2001); No Code Available (3191)
Date of Event	12/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Implant date: (b)(6) 2018.(b)(4).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 relevant information is identified, a supplement 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 malignant obstruction in the esophagus/stomach during a stent placement procedure performed on (b)(6) 2018.Reportedly, the stent was placed 28 to 30 cm from the incisors.The patient's tissue was friable.The patient underwent radiation/chemotherapy post stent placement.According to the complainant, on (b)(6) 2018, the patient presented with pain on the left side, and it started 10 to 14 days ago.On (b)(6) 2018, a computed tomography (ct) scan was performed and showed the stent had migrated.An esophagogastroduodenoscopy (egd) procedure was also performed and confirmed the stent had migrated and lodged into the fundus.Reportedly, the stent had eroded through the gastric wall and into the diaphragm and lungs.The stent was removed from the patient with an alligator forceps, and a chest tube was placed.Reportedly, the stent was intact when removed, except for damage observed due to removal on the distal end.Reportedly, the stricture was resolved and the patient was in a hospice care.

• 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: 8296571
• Report Number: 3005099803-2019-00245
• Device Sequence Number: 1911676
• Product Code: ESW
• UDI-Device Identifier: 08714729765288
• UDI-Public: 08714729765288
• 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 Explanted Year: 2018
• 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: M00516940
• Device Catalogue Number: 1694
• 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: 50 YR