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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INNOVA VASCULAR; STENT, SUPERFICIAL FEMORAL ARTERY
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BOSTON SCIENTIFIC CORPORATION INNOVA VASCULAR; STENT, SUPERFICIAL FEMORAL ARTERY Back to Search Results
Model Number 26926
Medical Device Problem Codes Entrapment of Device (1212); Material Integrity Problem (2978)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/12/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Age at time of event: older than 18 years.
 
Event or Problem Description
It was reported that the stent became stuck on the guidewire.An innova stent was selected for use for a lower limb stent procedure in the left superficial femoral artery (sfa).The target lesion was moderately tortuous, severely calcified and 100% stenosed.During procedure, the stent delivery system became stuck to a non-bsc guidewire and the delivery shaft became stretched.The stent was then removed with the guidewire together, and the procedure was completed with another innova stent.There were no patient complications reported.
 
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Brand Name
INNOVA VASCULAR
Common Device Name
STENT, SUPERFICIAL FEMORAL ARTERY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8214561
Report Number2134265-2018-64608
Device Sequence Number16841993
Product Code NIP
UDI-Device Identifier08714729873686
UDI-Public08714729873686
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
P140028
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/03/2019
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
Operator of Device Health Professional
Device Expiration Date12/31/2018
Device Model Number26926
Device Catalogue Number26926
Device Lot Number0018733069
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/17/2018
Initial Report FDA Received Date01/03/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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