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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 Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/20/2021
Event Type  Injury  
Event Description
It was reported that the stent foreshortened.The over 60% stenosed target lesion was located in the severely tortuous and moderately calcified iliac artery.Lesion length was 15cm.A 7mm x 150mm x 130cm innova was selected for use in a stenting procedure.The lesion was predilated using a 5mm mustang balloon.A 15cm innova stent shortened after deployment.The stent appeared to be under 10cm.During deployment, the stent was pulled forward.Three innova stents were used to complete the procedure.There were no patient complications and the patient's status was good.
 
Event Description
It was reported that the stent foreshortened.The over 60% stenosed target lesion was located in the severely tortuous and moderately calcified iliac artery.Lesion length was 15cm.A 7mm x 150mm x 130cm innova was selected for use in a stenting procedure.The lesion was predilated using a 5mm mustang balloon.A 15cm innova stent shortened after deployment.The stent appeared to be under 10cm.During deployment, the stent was pulled forward.Three innova stents were used to complete the procedure.There were no patient complications and the patient's status was good.It was further reported that a 7mm x 150mm x 130cm innova, a 7mm x 60mm x 130cm innova , and a a 7mm x 40mm x 130cm innova were selected for use.All three stents were implanted into the common iliac artery.All three stents shortened during the last time in deployment.Intervention was performed in the severely calcified iliac artery.
 
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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 Key13002101
MDR Text Key282268614
Report Number2134265-2021-15227
Device Sequence Number1
Product Code NIP
Combination Product (y/n)N
Reporter Country CodeKS
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 01/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/03/2022
Device Model Number26920
Device Catalogue Number26920
Device Lot Number0024705281
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/04/2019
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age58 YR
Patient SexMale
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