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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 Detachment of Device or Device Component (2907); Activation Failure (3270)
Patient Problem No Code Available (3191)
Event Date 07/21/2020
Event Type  Injury  
Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event Description
It was reported that device detachment occurred.An 8.0 x 40 x 135 cm express ld stent was advanced for treatment.However, before reaching the nominal pressure, the stent detached with the balloon.Another balloon was used to make the stent fully deploy.There were no further patient complications nor injuries reported and the patient's status was stable.
 
Event Description
It was reported that device detachment occurred.An 8.0x40x135 cm express ld stent was advanced for treatment.However, before reaching the nominal pressure, the stent detached with the balloon.Another balloon was used to make the stent fully deploy.There were no further patient complications nor injuries reported and the patient's status was stable.It was further reported that the 75% stenosed target lesion was located in the non-tortuous and moderately calcified iliac artery.Both the stent and the balloon did not detached from the shaft.The stent was deployed from the balloon prior to full balloon expansion.
 
Manufacturer Narrative
B1 adverse event/product problem corrected from product problem to adverse event and product problem.A2- age at time of event: 18 years or older.
 
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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 Key10264868
MDR Text Key198543788
Report Number2134265-2020-09218
Device Sequence Number1
Product Code NIO
UDI-Device Identifier08714729392477
UDI-Public08714729392477
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,distri
Type of Report Initial,Followup
Report Date 07/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/28/2022
Device Model Number20226
Device Catalogue Number20226
Device Lot Number0024848908
Was Device Available for Evaluation? No
Date Manufacturer Received07/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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