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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INNOVA; STENT, SUPERFICIAL FEMORAL ARTERY
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BOSTON SCIENTIFIC CORPORATION INNOVA; STENT, SUPERFICIAL FEMORAL ARTERY Back to Search Results
Model Number 26921
Device Problem Premature Activation (1484)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/28/2021
Event Type  malfunction  
Event Description
It was reported that the stent inadvertently deployed.An 6 x 100 x 130 innova vascular self expanding stent was selected for an arterial stent placement procedure for lower extremity artery stenosis.When the package was opened during preparation, it was noticed that the stent was partially deployed.The procedure was completed with a different device.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr: the returned product consisted of an innova sds.The outer sheath, tip and the remainder of the device were checked for damage.The catheter shaft showed no damage.The stent was deployed approximately 1cm from the distal marker band.The blue pull handle was partially pulled approximately.5cm from the handle body.X-ray imaging saw no internal damage.Inspection of the remainder of the device, apart from the observed issue, revealed no other issues or irregularities.
 
Event Description
It was reported that the stent inadvertently deployed.An 6 x 100 x 130 innova vascular self expanding stent was selected for an arterial stent placement procedure for lower extremity artery stenosis.When the package was opened during preparation, it was noticed that the stent was partially deployed.The procedure was completed with a different device.No patient complications were reported.
 
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Brand Name
INNOVA
Type of Device
STENT, SUPERFICIAL FEMORAL ARTERY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12834410
MDR Text Key280929735
Report Number2134265-2021-14392
Device Sequence Number1
Product Code NIP
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P140028
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/04/2024
Device Model Number26921
Device Catalogue Number26921
Device Lot Number0026918103
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/14/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/05/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age65 YR
Patient SexMale
Patient Weight70 KG
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