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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLSTENT ENDOPROSTHESIS; PROSTHESIS, TRACHEAL, EXPANDABLE
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BOSTON SCIENTIFIC - GALWAY WALLSTENT ENDOPROSTHESIS; PROSTHESIS, TRACHEAL, EXPANDABLE Back to Search Results
Model Number UNK272
Device Problems Break (1069); Occlusion Within Device (1423); Unraveled Material (1664)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Injury  
Event Description
It was reported to boston scientific corporation on (b)(6) 2014 that a wallstent enteral stent had been implanted in the pylorus during a stent placement procedure performed on an unknown date.According to the complainant, the stent had been in-situ for several years.During an endoscopic procedure on an unknown date, the physician noted that the middle of the stent was broken into two pieces and there was tumor ingrowth within the stent.It was also reported that the stent had unraveled and endoscopic removal of the stent was not possible.The stent was removed surgically.The patient's condition at the conclusion of the procedure was reported to be stable.Boston scientific has been unable obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available, a supplemental report will be submitted.
 
Manufacturer Narrative
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.(b)(4) for the reported event of stent broken.(b)(4) for the reported event of tissue ingrowth within the stent.(b)(4) for the reported event of stent unraveled.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) 2014 that a wallstent enteral stent had been implanted in the pylorus during a stent placement procedure performed on an unknown date.According to the complainant, the stent had been in-situ for several years.During an endoscopic procedure on an unknown date, the physician noted that the middle of the stent was broken into two pieces and there was tumor ingrowth within the stent.It was also reported that the stent had unraveled and endoscopic removal of the stent was not possible.The stent was removed surgically.The patient's condition at the conclusion of the procedure was reported to be stable.Boston scientific has been unable obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available a supplemental report will be submitted.
 
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Brand Name
WALLSTENT ENDOPROSTHESIS
Type of Device
PROSTHESIS, TRACHEAL, EXPANDABLE
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
ballybrit business park
galway
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
ballybrit business park
galway
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key4146699
MDR Text Key4787006
Report Number3005099803-2014-03312
Device Sequence Number1
Product Code JCT
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K982184
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 09/15/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberUNK272
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/07/2014
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 Number1
Patient Outcome(s) Required Intervention;
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