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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX ESOPHAGEAL; PROSTHESIS, ESOPHAGEAL
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BOSTON SCIENTIFIC CORPORATION WALLFLEX ESOPHAGEAL; PROSTHESIS, ESOPHAGEAL Back to Search Results
Model Number M00516910
Device Problems Positioning Failure (1158); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2023
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a wallflex esophageal partially covered stent was used to treat a malignant stricture in the esophagus during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the stent was unable to be deployed.The handle felt flimsy and the white olive tip was detached from the delivery system.The stent was fully covered by the outer sheath when it was removed from the patient.There was no attempt to remove the tip from the patient and the physician decided to let the tip pass out naturally.The procedure was completed with another wallflex esophageal stent.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of tip detached.
 
Event Description
It was reported to boston scientific corporation that a wallflex esophageal partially covered stent was used to treat a malignant stricture in the esophagus during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the stent was unable to be deployed.The handle felt flimsy and the white olive tip was detached from the delivery system.The stent was fully covered by the outer sheath when it was removed from the patient.There was no attempt to remove the tip from the patient and the physician decided to let the tip pass out naturally.The procedure was completed with another wallflex esophageal stent.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of tip detached.Block h10: a wallflex esophageal partially covered stent and delivery system were received for analysis.The stent was received fully covered and undeployed.Visual inspection found the tip detached and was not returned.The outer blue sheath and the outer clear sheath were kinked.During functional inspection, the stent was deployed without any problems by actuating the delivery system.No other problems were noted with the stent and delivery system.Product analysis confirmed the reported event of tip detachment of device or device component; however, the reported event of stent failure to deploy was not confirmed as the stent was able to be deployed during functional inspection.It is most likely that procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied) resulted in the reported event of tip detached and the observed events of outer blue sheath and outer clear sheath kinked.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.
 
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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 CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key18393344
MDR Text Key331673600
Report Number3005099803-2023-06798
Device Sequence Number1
Product Code ESW
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
K073266
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/05/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00516910
Device Catalogue Number1691
Device Lot Number0030736852
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/12/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/19/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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