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

Model Number	M00516930
Medical Device Problem Codes	Break (1069); Migration (4003)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); No Code Available (3191)
Date of Event	10/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.However, it was reported that the device was not used past its expiry date.(b)(4).The complainant indicated that the suspect 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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on november 05, 2019 that a wallflex esophageal partially covered stent was implanted to treat a malignant stricture in the esophagus and stomach due to advanced esophageal cancer, during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2019.Reportedly, the patient's anatomy was almost occluded and was not dilated prior to stent placement.According to the complainant, on (b)(6) 2019, the patient presented with dysphagia.An imaging followed by egd was performed and noticed the stent had fully migrated into the stomach.The physician attempted to remove the stent but the stent retrieval loop broke and the stent was not removed.On (b)(6) 2019, the physician attempted to remove the stent for the second time with 2 rat tooth forceps, snares, retrieval hood and an overtube but still the stent was not removed.Reportedly, the stent broke and the stent wires were exposed.Reportedly, the stent remains implanted inside the patient and there is no plan to remove the stent due to patient's health and advanced state of cancer.

• 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: 9379264
• Report Number: 3005099803-2019-05742
• Device Sequence Number: 3103701
• Product Code: ESW
• UDI-Device Identifier: 08714729765271
• UDI-Public: 08714729765271
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K073266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/26/2019

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: M00516930
• Device Catalogue Number: 1693
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2019
• Initial Report FDA Received Date: 11/26/2019
• 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