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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 Premature Activation (1484)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/10/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the stent was partially deployed inside of the packaging.A 6 x 60 x 130 innova self expanding stent was selected for a patient procedure.During preparation, the stent was noted to be partially deployed upon removal from box; a few tines were showing.The device was not implanted.The procedure was completed successfully.No patient complications were reported.
 
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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 Key11914119
Report Number2134265-2021-06968
Device Sequence Number17200316
Product Code NIP
UDI-Device Identifier08714729874003
UDI-Public08714729874003
Combination Product (Y/N)N
Initial Reporter StateNY
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) 06/01/2021
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 Date02/07/2026
Device Model Number26924
Device Catalogue Number26924
Device Lot Number0026768420
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/10/2021
Initial Report FDA Received Date06/01/2021
Patient Sequence Number1
Patient Age87 YR
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