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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 Code Positioning Problem (3009)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/29/2018
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the stent moved during deployment.A 6x60x130mm innova vascular stent was selected for use for a peripheral stenting procedure in the superficial femoral artery (sfa).The physician went to deploy the stent, and the stent moved about 3mm during deployment.There were no deployment difficulties noted.The physician needed to use a second, larger innova stent to complete the procedure.There were no patient complications and the patient's condition post procedure was fine.
 
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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 Key8066378
Report Number2134265-2018-62673
Device Sequence Number11378347
Product Code NIP
UDI-Device Identifier08714729874003
UDI-Public08714729874003
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
PMA/510(K) Number
P140028
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/13/2018
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
Operator of Device Health Professional
Device Expiration Date07/31/2021
Device Model Number26924
Device Catalogue Number26924
Device Lot Number0022453168
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/29/2018
Initial Report FDA Received Date11/13/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age67 YR
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