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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 Problems Positioning Failure (1158); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/14/2023
Event Type  malfunction  
Event Description
It was reported that the stent was kinked.A 6 x 40 x 130 innova self-expanding stent was selected for use in a stenting procedure.An ipsilateral approach was used to access the 70% stenosed target lesion that was mildly calcified and located in the moderately tortuous superficial femoral artery.The lesion was pre-dilated.During the procedure, the stent failed to deploy.The physician opened the sheath and found that the stent was kinked.The procedure was completed with another of the same device.No patient complications were reported.
 
Manufacturer Narrative
Device eval 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 multiple kinks along the sheath.Microscopic examination revealed no additional damages.The stent was still inside the sheath and did not appear to be damaged.The thumbwheel lock was missing.
 
Event Description
It was reported that the stent was kinked.A 6 x 40 x 130 innova self-expanding stent was selected for use in a stenting procedure.An ipsilateral approach was used to access the 70% stenosed target lesion that was mildly calcified and located in the moderately tortuous superficial femoral artery.The lesion was pre-dilated.During the procedure, the stent failed to deploy.The physician opened the sheath and found that the stent was kinked.The procedure was completed with another of the same 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
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key17725614
MDR Text Key323299229
Report Number2124215-2023-49095
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 Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/08/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2023
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 Number0030706951
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/18/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/13/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age59 YR
Patient SexMale
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