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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 Premature Activation (1484); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/05/2023
Event Type  malfunction  
Event Description
It was reported that the stent inadvertently deployed.A 7 x 150 x 130 innova self-expanding stent was selected for use in a percutaneous arterial stenting procedure in the occluded iliac artery.Puncture was performed at the base of the right thigh.A non-boston scientific 6f 40 long sheath was placed, and after percutaneous balloon dilation, stent placement was planned.The innova stent was unpacked aseptically and advanced to the lesion via the long sheath.During normal delivery, it was noted that the device was stuck and could not be advanced.The device was removed from the patient's body.After re-flushing, it was noted that part of the stent at the tip was exposed and inflated and was stuck with the sheath.During delivery, neither the yellow safety buckle nor the blue shaft was moved.The procedure was completed with another stent.There were no patient complications reported, and the patient was in stable condition following the procedure.
 
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 a kink to the outer sheath at the nosecone.The stent was partially deployed 15mm from the distal end of the middle sheath.Microscopic examination revealed no additional damages.The thumbwheel lock was still covering the thumbwheel.The pull rack was approximately 20mm from the handle.
 
Event Description
It was reported that the stent inadvertently deployed.A 7 x 150 x 130 innova self-expanding stent was selected for use in a percutaneous arterial stenting procedure in the occluded iliac artery.Puncture was performed at the base of the right thigh.A non-boston scientific 6f 40 long sheath was placed, and after percutaneous balloon dilation, stent placement was planned.The innova stent was unpacked aseptically and advanced to the lesion via the long sheath.During normal delivery, it was noted that the device was stuck and could not be advanced.The device was removed from the patient's body.After re-flushing, it was noted that part of the stent at the tip was exposed and inflated and was stuck with the sheath.During delivery, neither the yellow safety buckle nor the blue shaft was moved.The procedure was completed with another stent.There were no patient complications reported, and the patient was in stable condition following the procedure.
 
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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 Key17022511
MDR Text Key316148316
Report Number2124215-2023-26719
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
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2023
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 Number0028585527
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/14/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/20/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age69 YR
Patient SexFemale
Patient Weight54 KG
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