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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 26929
Medical Device Problem Code Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/20/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the stent foreshortened.A 6x120x130mm innova self-expanding stent was selected for use.Upon deployment, the stent foreshortened about 3cm.Post-dilation was performed using a 120mm balloon which confirmed the stent was almost 30mm shorter.The final stent placement was not ideal, but the entire lesion was covered.Post angiogram was fine.There were no patient complications and the patient was fine post procedure.
 
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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 Key9375280
Report Number2134265-2019-14435
Device Sequence Number16913443
Product Code NIP
UDI-Device Identifier08714729874034
UDI-Public08714729874034
Combination Product (Y/N)N
Initial Reporter StateAL
Initial Reporter CountryUS
PMA/510(K) Number
P140028
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/26/2019
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 Date09/05/2021
Device Model Number26929
Device Catalogue Number26929
Device Lot Number0022614431
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/20/2019
Initial Report FDA Received Date11/26/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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