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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 26928
Medical Device Problem Code Premature Activation (1484)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/24/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(6).
 
Event or Problem Description
It was reported that an inadvertent deployment occurred.A 7x100x130 innova self-expanding stent was selected for an angioplasty procedure in a lesion with minimal calcification, mostly atherosclerotic plaque, 80% stenosed and minimal tortuosity via contralateral approach.During preparation, after flushing the stent, it was discovered that the stent had already deployed approximately 1-2mm from the distal end of the stent.The device did not enter the patient.The procedure was completed with another shorter stent to complete the procedure.There were no complications to the patient 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 Key9719957
Report Number2134265-2020-01603
Device Sequence Number18914567
Product Code NIP
UDI-Device Identifier08714729874119
UDI-Public08714729874119
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
P140028
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/18/2020
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 Date04/24/2021
Device Model Number26928
Device Catalogue Number26928
Device Lot Number0022034286
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/28/2020
Initial Report FDA Received Date02/18/2020
Patient Sequence Number1
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