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

Model Number	M00516740
Medical Device Problem Codes	Use of Device Problem (1670); Migration (4003)
Health Effect - Clinical Codes	Nausea (1970); No Code Available (3191)
Date of Event	02/28/2020
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 device was 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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on august 06, 2020 that a wallflex esophageal fully covered stent was implanted to treat a gastric bypass anastomotic stricture during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2020.According to the complainant, about two weeks post stent placement, the patient contacted the physician and complained of nausea.Reportedly, the patient was scheduled for an emergent follow-up the next day.X-ray was obtained and confirmed that the stent had migrated into the jejunum.On (b)(6) 2020, the migrated stent was removed from the patient using rat tooth forceps.Reportedly, in (b)(6) 2020, a different stent was implanted.Reportedly, the nausea is probably due to the stricture.Note: according to the complainant, the wallflex esophageal fully covered stent was implanted to treat a gastric bypass anastomotic stricture.However, per wallflex esophageal fully covered stent system directions for use, the stent is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/ or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.Additionally, the wallflex esophageal fully covered stent system is contraindicated for placement in an esophago-jejunostomy (following gastrectomy), as peristalsis and altered anatomy may displace stent.

• 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: 10460654
• Report Number: 3005099803-2020-03568
• Device Sequence Number: 3218518
• Product Code: ESW
• UDI-Device Identifier: 08714729778073
• UDI-Public: 08714729778073
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K091510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2020

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: M00516740
• Device Catalogue Number: 1674
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 08/27/2020
• 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: 53 YR