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

Model Number M00516740

Device Problems Use of Device Problem (1670); Migration (4003)

Patient Problems Nausea (1970); No Code Available (3191)

Event Date 02/28/2020

Event Type  Injury  

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 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
• 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: 10460654
• MDR Text Key: 204598538
• Report Number: 3005099803-2020-03568
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729778073
• UDI-Public: 08714729778073
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091510
• 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: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00516740
• Device Catalogue Number: 1674
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2020
• 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: 53 YR