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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 26924
Medical Device Problem Codes Mechanical Problem (1384); Failure to Advance (2524)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/28/2018
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the stent inadvertently deployed.A 6 x 80 x 130 innova self expanding stent was selected for use for a lower extremity angio procedure.During procedure inside the patient, the innova stent was unable to cross the lesion.The physician decided to remove the stent.As the stent was removed from the 6f sheath, the outer sheath of the stent delivery system was accidentally retracted and the stent was exposed.A new innova stent was used to complete the procedure.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 Key7855164
Report Number2134265-2018-60852
Device Sequence Number16478474
Product Code NIP
UDI-Device Identifier08714729874010
UDI-Public08714729874010
Combination Product (Y/N)N
Initial Reporter StateFL
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) 09/07/2018
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 Date08/31/2019
Device Model Number26924
Device Catalogue Number26924
Device Lot Number0019550509
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/28/2018
Initial Report FDA Received Date09/07/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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