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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 12/01/2021
Event Type  malfunction  
Event Description
It was reported that inadvertent deployment occurred.The 60% stenosed target lesion was located in the severely tortuous and severely calcified thrombosed femoral artery.A 5 x 60 x 130 innova was selected for use.During unpacking, the stent was flushed and it was found that the device had deployed approximately 2mm.The procedure was completed with another of the same device.There were no patient complications and the patient's status was stable.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an innova self-expanding stent system.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the stent is partially deployed approximately 1cm from the middle sheath.There is a kink to the outer sheath at the nosecone.Microscopic examination revealed no additional damages.The lock and pull rack are still in the manufactured location but the middle sheath is no longer sitting on top of the proximal end of the tip.Inspection of the remainder of the device, revealed no other damage or irregularities.
 
Event Description
It was reported that inadvertent deployment occurred.The 60% stenosed target lesion was located in the severely tortuous and severely calcified thrombosed femoral artery.A 5 x 60 x 130 innova was selected for use.During unpacking, the stent was flushed and it was found that the device had deployed approximately 2mm.The procedure was completed with another of the same device.There were no patient complications and the patient's status was stable.
 
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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 Key12990743
MDR Text Key282275792
Report Number2134265-2021-15475
Device Sequence Number1
Product Code NIP
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/07/2022
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
Device Operator Health Professional
Device Model Number26921
Device Catalogue Number26921
Device Lot Number0027535110
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/01/2021
Initial Date FDA Received12/13/2021
Supplement Dates Manufacturer Received01/10/2022
Supplement Dates FDA Received02/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/22/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age43 YR
Patient SexMale
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