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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 26926
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Codes Pain (1994); Obstruction/Occlusion (2422)
Date of Event 05/12/2021
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the stent fractured and occluded.It was treated with a laser, drug-coated balloons, and another stent was placed over the fractured stent.A 6 x 150 x 130 innova self expanding stent was previously placed on (b)(6) 2020 at the mildly tortuous proximal to mid superficial femoral artery.At a follow up appointment, for leg pain on (b)(6) 2021, an angiogram was performed.The angiogram revealed that the previously placed innova stent was completely fractured in 2 places and the vessel stents were completely occluded.This was treated with laser, a drug coated balloon, and a non-bsc stent (placed over the fractured stent).
 
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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 Key11931635
Report Number2134265-2021-07188
Device Sequence Number4491118
Product Code NIP
UDI-Device Identifier08714729874041
UDI-Public08714729874041
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
Device Implanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/03/2021
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 Date03/10/2025
Device Model Number26926
Device Catalogue Number26926
Device Lot Number0025339804
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/12/2021
Initial Report FDA Received Date06/03/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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