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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 02/13/2024
Event Type  malfunction  
Event Description
It was reported that stent damage occurred.The target lesion was located in the severely tortuous and severely calcified radial arteriovenous fistula.A 7x80x75 innova stent was selected for use in a percutaneous transluminal angioplasty.However, during preparation, it was noted that the device had a bad stent strut.The procedure was completed with another of same device.There were no complications reported and the patient condition was stable.
 
Event Description
It was reported that stent damage occurred.The target lesion was located in the severely tortuous and severely calcified radial arteriovenous fistula.A 7x80x75 innova stent was selected for use in a percutaneous transluminal angioplasty.However, during preparation, it was noted that the device had a bad stent strut.The procedure was completed with another of same device.There were no complications reported and the patient condition was stable.
 
Manufacturer Narrative
Device evaluated by mfr: 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.Microscopic examination revealed no additional damages.The stent appears to have been deployed and did not return for analysis.Inspection of the remainder of the device, revealed no other damage or irregularities.Product analysis found damage but it is not likely to have contributed to the reported event.
 
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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 Key18808409
MDR Text Key336570867
Report Number2124215-2024-12268
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 Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 02/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/29/2024
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 Number0030437814
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/13/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/27/2022
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 Age54 YR
Patient SexMale
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