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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 26920
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/04/2022
Event Type  malfunction  
Event Description
It was reported that the stent partially deployed.A 5x150x130 innova self-expanding stent was selected for use in a stenting procedure.During the procedure, the stent deployment system became stuck.Using forceps, the surgeon disassembled the handle in order to release the stent.No patient complications were reported.
 
Event Description
It was reported that the stent partially deployed.A 5x150x130 innova self-expanding stent was selected for use in a stenting procedure.During the procedure, the stent deployment system became stuck.Using forceps, the surgeon disassembled the handle in order to release the stent.No patient complications were reported.
 
Manufacturer Narrative
Device eval by manufacturer: the device was not received for analysis; however, media from the clinical procedure was provided to boston scientific and reviewed.The media concluded: the handle was taken apart by the physician.
 
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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
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15838208
MDR Text Key305595165
Report Number2124215-2022-47651
Device Sequence Number1
Product Code NIP
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/19/2022
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 Number26920
Device Catalogue Number26920
Device Lot Number0029763175
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/10/2022
Initial Date FDA Received11/21/2022
Supplement Dates Manufacturer Received12/06/2022
Supplement Dates FDA Received12/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/14/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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