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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALLFLEX ESOPHAGEAL; PROSTHESIS, ESOPHAGEAL
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WALLFLEX ESOPHAGEAL; PROSTHESIS, ESOPHAGEAL Back to Search Results
Model Number M00516720
Medical Device Problem Code Migration (4003)
Health Effect - Clinical Code Discomfort (2330)
Date of Event 10/08/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The event date is unknown; however, it was reported that the stent was successfully implanted on (b)(6) 2021.The complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.(b)(4).The complainant indicated that the stent remains implanted and will not be returned for evaluation; therefore, a problem 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 (b)(6) 2021 that a wallflex esophageal fully covered stent was implanted to treat a malignant stricture in the esophagus during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was not dilated prior to stent placement.Post stent placement, the patient experienced discomfort and imaging was performed.It was noted that the stent migrated.Reportedly, the stent remains implanted and the physician was comfortable leaving the stent implanted.There are no known treatments or interventions for the patient's discomfort.
 
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Brand Name
WALLFLEX ESOPHAGEAL
Common Device Name
PROSTHESIS, ESOPHAGEAL
MDR Report Key12752257
Report Number3005099803-2021-05616
Device Sequence Number13816610
Product Code ESW
UDI-Device Identifier08714729778059
UDI-Public08714729778059
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K091510
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 11/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberM00516720
Device Catalogue Number1672
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/11/2021
Initial Report FDA Received Date11/04/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
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