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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 Fracture (1260)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/29/2019
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a stent fracture occurred.The 90% stenosed target lesion was located in the non-tortuous external iliac vein.Following pre-dilation, an 8 x 120 x 130 innova self expanding stent was advanced ipsilateral and deployed without incident.The stent was post-dilated with three balloons.The last being an 8mm high pressure balloon.During this dilation, the balloon fractured the stent.Another stent was placed to cover the fractured innova stent.There were no patient complications and the patient was fine post procedure.There was no residual and the stent looked great when the procedure was complete.
 
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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 Key8713899
Report Number2134265-2019-07042
Device Sequence Number2446306
Product Code NIP
UDI-Device Identifier08714729874218
UDI-Public08714729874218
Combination Product (Y/N)N
Initial Reporter StateOR
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) 06/19/2019
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 Date08/07/2020
Device Model Number26929
Device Catalogue Number26929
Device Lot Number0020980821
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/31/2019
Initial Report FDA Received Date06/19/2019
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 Required Intervention;
Patient Age78 YR
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