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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INNOVA VASCULAR; STENT, SUPERFICIAL FEMORAL ARTERY
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BOSTON SCIENTIFIC CORPORATION INNOVA VASCULAR; STENT, SUPERFICIAL FEMORAL ARTERY Back to Search Results
Model Number 26924
Device Problems Fracture (1260); Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)
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 partially deployed and became fractured.This 8 x 80 x 75 innova vascular stent was selected for use in a superficial femoral artery (sfa) stenting procedure.The 70% stenosed sfa lesion was mildly calcified and mildly tortuous.During the procedure, the physician believed the stent was fully deployed using the thumbwheel; therefore, pulled on the catheter to remove it, but felt resistance.At that time, they felt a break in the stent at the proximal sfa.Post dilation of the lesion was performed, and the broken piece of stent was removed which was still attached to the catheter.A portion of the stent remained implanted.Additionally, it was thought that the stent had not been fully deployed before pulling out the catheter.There were no patient complications, and it was noted that there was no need for a future procedure at that time.
 
Event Description
It was reported that the stent was partially deployed and became fractured.This 8 x 80 x 75 innova vascular stent was selected for use in a superficial femoral artery (sfa) stenting procedure.The 70% stenosed sfa lesion was mildly calcified and mildly tortuous.During the procedure, the physician believed the stent was fully deployed using the thumbwheel; therefore, pulled on the catheter to remove it, but felt resistance.At that time, they felt a break in the stent at the proximal sfa.Post dilation of the lesion was performed, and the broken piece of stent was removed which was still attached to the catheter.A portion of the stent remained implanted.Additionally, it was thought that the stent had not been fully deployed before pulling out the catheter.There were no patient complications, and it was noted that there was no need for a future procedure at that time.
 
Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this innova vascular stent was returned with an unknown terumo sheath.The outer sheath, tip, inner sheath and the remainder of the device were inspected for damage.Visual examination revealed a kink to the outer sheath at the nosecone.There was buckling to the outer sheath 4cm and 4.7cm from the nosecone.The stent was separated, and it appeared that only approximately 4cm was returned.Microscopic examination revealed no additional damages.Inspection of the remainder of the device revealed no other damage or irregularities.Product analysis found damage to the device that could have contributed to the reported event.
 
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Brand Name
INNOVA VASCULAR
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 Key17619188
MDR Text Key322196877
Report Number2124215-2023-45854
Device Sequence Number1
Product Code NIP
UDI-Device Identifier08714729873839
UDI-Public08714729873839
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P140028
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/18/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number26924
Device Catalogue Number26924
Device Lot Number0030968018
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/14/2023
Initial Date FDA Received08/24/2023
Supplement Dates Manufacturer Received09/14/2023
Supplement Dates FDA Received09/18/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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