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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 Codes Fracture (1260); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/12/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that a partial deployment and stent fracture occurred.An innova stent was selected for use during a superficial femoral artery stenting procedure.During deployment, the stent did not fully deploy all the way resulting in half of the stent hanging out of the catheter.A cut down was performed to access the external iliac artery to retrieve the fractured portion of the stent.No adverse patient events were reported.The patient was noted to have fully recovered from the 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 Key12264498
Report Number2134265-2021-09799
Device Sequence Number14579625
Product Code NIP
UDI-Device Identifier08714729873952
UDI-Public08714729873952
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
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) 08/02/2021
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 Date04/15/2026
Device Model Number26926
Device Catalogue Number26926
Device Lot Number0027152238
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/12/2021
Initial Report FDA Received Date08/02/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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