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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX¿ ESOPHAGEAL; PROSTHESIS, ESOPHAGEAL

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BOSTON SCIENTIFIC - GALWAY WALLFLEX¿ ESOPHAGEAL; PROSTHESIS, ESOPHAGEAL Back to Search Results
Model Number UNK477
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/16/2015
Event Type  malfunction  
Manufacturer Narrative
Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.The complainant was unable to report the upn and lot number; therefore, the manufacture date and expiration date are unknown.However, the complainant stated that the device was used prior to the expiration date.Reported event of stent migration.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 (b)(6) 2015 that a wallflex¿ esophageal fully covered stent was used in the distal esophagus during a gastroscopy procedure performed on (b)(6) 2015.According to the complainant, the stent was placed to treat a 3-4 cm post radiation stricture which is approximately 3-4 cm proximal to the gastro-oesophageal junction (goj).Reportedly the patient's anatomy was not dilated prior to stent placement.According to the complainant, during the procedure the physician deployed the wallflex¿ esophageal stent in the desired location without issue.Approximately 4 hours after stent placement, the patient had a coughing fit and coughed the stent up and out of from the mouth.The physician was undecided whether to place another stent at the stricture.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
A fully deployed wallflex¿ esophageal fully covered stent was returned for analysis.Visual and microscopic analysis found that there were no issues noted on the profile of the stent that could have contributed to the complaint incident.During product analysis, the proximal flare diameter, the distal flare diameter, and the overall length of the stent were measured which were within specifications.No other issues were identified during the product analysis."stent migration" is a known complication associated with the use of this device, and is listed in the directions for use (dfu) / product label.Therefore, the root cause of this complaint is anticipated procedural complication.
 
Event Description
It was reported to boston scientific corporation on (b)(4) 2015 that a wallflex¿ esophageal fully covered stent was used in the distal esophagus during a gastroscopy procedure performed on (b)(6) 2015.According to the complainant, the stent was placed to treat a 3-4 cm post radiation stricture which is approximately 3-4 cm proximal to the gastro-oesophageal junction (goj).Reportedly the patient's anatomy was not dilated prior to stent placement.According to the complainant, during the procedure the physician deployed the wallflex¿ esophageal stent in the desired location without issue.Approximately 4 hours after stent placement, the patient had a coughing fit and coughed the stent up and out of from the mouth.The physician was undecided whether to place another stent at the stricture.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
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Brand Name
WALLFLEX¿ ESOPHAGEAL
Type of Device
PROSTHESIS, ESOPHAGEAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key5219952
MDR Text Key30995496
Report Number3005099803-2015-03099
Device Sequence Number1
Product Code ESW
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K091510
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/19/2015
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
Device Operator Health Professional
Device Model NumberUNK477
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/19/2015
Initial Date FDA Received11/12/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/12/2016
Was Device Evaluated by Manufacturer? Yes
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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