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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS LD ILIAC / BILIARY; STENT, ILIAC
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BOSTON SCIENTIFIC CORPORATION EXPRESS LD ILIAC / BILIARY; STENT, ILIAC Back to Search Results
Model Number 20226
Device Problems Material Rupture (1546); Activation Failure (3270)
Patient Problem Vascular Dissection (3160)
Event Date 02/19/2020
Event Type  Injury  
Event Description
It was reported that balloon rupture, stent inadequate apposition, and vessel dissection occurred.The target lesion was located in the left common iliac vessel.Following pre-dilatation with an 8x40 balloon, a 10.0x30x75cm express ld iliac / biliary stent was advanced for treatment.However, upon inflating the balloon inside the stent, the balloon ruptured.The balloon was pulled out.The stent was noted to be dog-boned, which could not fully inflate the stent.Another non-bsc balloon was used to post dilate the stent.There was a slight dissection noted from the common iliac towards the aorta and the physician post dilated it again with the non-bsc balloon.No further patient complications were reported and the patient did good.
 
Event Description
It was reported that balloon rupture, stent inadequate apposition, and vessel dissection occurred.The target lesion was located in the left common iliac vessel.Following pre-dilatation with an 8x40 balloon, a 10.0x30x75cm express ld iliac / biliary stent was advanced for treatment.However, upon inflating the balloon inside the stent, the balloon ruptured.The balloon was pulled out.The stent was noted to be dog-boned, which could not fully inflate the stent.Another non-bsc balloon was used to post dilate the stent.There was a slight dissection noted from the common iliac towards the aorta and the physician post dilated it again with the non-bsc balloon.No further patient complications were reported and the patient did good.
 
Manufacturer Narrative
Device evaluated by mfr.: the device was returned with the stent detached from the balloon.The stent was not returned for analysis as it was deployed during the procedure.Blood was identified in the balloon which is indicative of a leak.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon and liquid was observed to be leaking from a balloon pinhole 5mm distal of the proximal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 12 atmospheres.A visual and microscopic examination identified no issues with the tip of the device during analysis that could have contributed to the complaint incident.A visual and tactile examination identified no issues with the shaft that could potentially have contributed to the complaint incident.No other issues were identified during the product analysis.
 
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Brand Name
EXPRESS LD ILIAC / BILIARY
Type of Device
STENT, ILIAC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9799961
MDR Text Key182388671
Report Number2134265-2020-02700
Device Sequence Number1
Product Code NIO
UDI-Device Identifier08714729392071
UDI-Public08714729392071
Combination Product (y/n)N
PMA/PMN Number
K133110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/15/2020
Device Model Number20226
Device Catalogue Number20226
Device Lot Number0021015198
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/03/2020
Initial Date Manufacturer Received 02/20/2020
Initial Date FDA Received03/06/2020
Supplement Dates Manufacturer Received04/06/2020
Supplement Dates FDA Received04/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age60 YR
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