Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INNOVA; STENT, SUPERFICIAL FEMORAL ARTERY
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION INNOVA; STENT, SUPERFICIAL FEMORAL ARTERY Back to Search Results
Model Number 26921
Device Problems Difficult to Remove (1528); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/07/2023
Event Type  malfunction  
Event Description
It was reported that the device was difficult to remove.A 6 x 120 x 130 innova self-expanding stent was selected for use in a lower extremity arterial occlusion recanalization procedure.The 85% stenosed target lesion was located in the severely calcified superficial femoral artery.The lesion was predilated.While advancing the device, it felt difficult and could not be advanced into the lesion.The stent was not implanted.Upon removal of the device, it stuck a little, and several attempts were made before the stent was finally removed.The procedure was completed with only balloon dilation.No patient complications were reported.
 
Manufacturer Narrative
Device eval by manufacturer: returned product consisted of an innova self-expanding stent measuring approximately 120mm.The delivery system was not returned.Visual examination revealed no damages.Product analysis found no damage on the returned stent.
 
Event Description
It was reported that the device was difficult to remove.A 6 x 120 x 130 innova self-expanding stent was selected for use in a lower extremity arterial occlusion recanalization procedure.The 85% stenosed target lesion was located in the severely calcified superficial femoral artery.The lesion was predilated.While advancing the device, it felt difficult and could not be advanced into the lesion.The stent was not implanted.Upon removal of the device, it stuck a little, and several attempts were made before the stent was finally removed.The procedure was completed with only balloon dilation.No patient complications were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
jeff wallner
4100 hamline ave n
arden hills, MN 55112
6515811560
MDR Report Key16891363
MDR Text Key314810249
Report Number2124215-2023-22170
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 06/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2023
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 Number0030077386
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/24/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/02/2022
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 Age77 YR
Patient SexMale
Patient Weight75 KG
-
-