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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT ENDOPROSTHESIS; CATHETER, BILIARY, DIAGNOSTIC
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BOSTON SCIENTIFIC CORPORATION WALLSTENT ENDOPROSTHESIS; CATHETER, BILIARY, DIAGNOSTIC Back to Search Results
Model Number 26280
Device Problems Premature Activation (1484); Retraction Problem (1536)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/01/2019
Event Type  Injury  
Event Description
It was reported that reconstrainment difficulties occurred.The target lesion wa located in the right common iliac vein.A 16x60/9fr wallstent uni was advanced for treatment along with a 18x90 wallstent in an attempt to barrel both stents into the inferior vena cava (ivc).However, it was noted that 20% of the 16x60 stent was deployed in the ivc.While attempting to recapture the stent for repositioning, the stent fully deployed.Another 18x90mm wallstent was deployed inside the stent and inflated with a 16x40mm xxl balloon catheter on both sides.No patient complications were reported and patient status was fine and stable.
 
Manufacturer Narrative
Device evaluated by mfr.: the device was returned with the stent fully deployed.The stent was not returned for analysis.No damage or issues were identified with the stent cup or stent holder that could potentially have contributed to the complaint incident.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile examination identified no kinks or damage to the shaft of the device.No other issues were identified during the product analysis.
 
Event Description
It was reported that reconstrainment difficulties occurred.The target lesion wa located in the right common iliac vein.A 16x60/9fr wallstent uni was advanced for treatment along with a 18x90 wallstent in an attempt to barrel both stents into the inferior vena cava (ivc).However, it was noted that 20% of the 16x60 stent was deployed in the ivc.While attempting to recapture the stent for repositioning, the stent fully deployed.Another 18x90mm wallstent was deployed inside the stent and inflated with a 16x40mm xxl balloon catheter on both sides.No patient complications were reported and patient status was fine and stable.
 
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Brand Name
WALLSTENT ENDOPROSTHESIS
Type of Device
CATHETER, BILIARY, DIAGNOSTIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9395936
MDR Text Key168653171
Report Number2134265-2019-14640
Device Sequence Number1
Product Code MAF
UDI-Device Identifier08714729204046
UDI-Public08714729204046
Combination Product (y/n)N
PMA/PMN Number
K152842
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number26280
Device Catalogue Number26280
Device Lot Number0024329408
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2020
Date Manufacturer Received03/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age62 YR
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