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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 Consequences Or Impact To Patient (2199)
Event Date 10/14/2020
Event Type  malfunction  
Event Description
It was reported that the stent inadvertently deployed.An 8mm x 60mm x 130cm innova was selected for use in an abdominal aortic aneurysm in the iliac.During preparation outside the body, the stent inadvertently deployed 5-6 mm.The device was never used inside the patient.The procedure was completed with another of the same device.There were no patient complications reported, and the patient was stable post-procedure.
 
Manufacturer Narrative
Device evaluated by manufacturer: 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 and 93cm from the nosecone.Microscopic examination revealed no additional damages.Inspection of the remainder of the device, revealed no other damage or irregularities.
 
Event Description
It was reported that the stent inadvertently deployed.An 8mm x 60mm x 130cm innova was selected for use in an abdominal aortic aneurysm in the iliac.During preparation outside the body, the stent inadvertently deployed 5-6 mm.The device was never used inside the patient.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable post-procedure.
 
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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
MDR Report Key10740840
MDR Text Key213219687
Report Number2134265-2020-14840
Device Sequence Number1
Product Code NIP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/16/2023
Device Model Number26921
Device Catalogue Number26921
Device Lot Number0025059089
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/10/2020
Date Manufacturer Received11/17/2020
Patient Sequence Number1
Patient Age79 YR
Patient Weight68
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