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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
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BOSTON SCIENTIFIC CORPORATION ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING Back to Search Results
Model Number 24653
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/30/2019
Event Type  malfunction  
Event Description
It was reported that a partial deployment of the stent occurred.A 6x120x75 eluvia drug-eluting vascular stent system was selected for a procedure in the superficial femoral artery (sfa).A contralateral approach was used to advance the device through the 6f introducer.During the procedure, the first 5mm of the stent was deployed and then the thumbwheel became blocked.The stent could not be further deployed and the physician forced the removal of the stent successfully.The procedure was completed with another of the same device.There were no patient complications reported.
 
Event Description
It was reported that a partial deployment of the stent occurred.A 6x120x75 eluvia drug-eluting vascular stent system was selected for a procedure in the superficial femoral artery (sfa).A contralateral approach was used to advance the device through the 6f introducer.During the procedure, the first 5mm of the stent was deployed and then the thumbwheel became blocked.The stent could not be further deployed and the physician forced the removal of the stent successfully.The procedure was completed with another of the same device.There were no patient complications reported.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an eluvia self-expanding stent system with an introducer sheath.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that pull rack was fully extended and the stent was no longer inside the device.The inner liner was separated, and the tip of the device was missing.The stent appeared to be inside the introducer sheath.The introducer sheath was x-rayed to find the missing pieces.The stent and tip of the device could be seen inside the sheath.The proximal radiopaque marker could not be seen, so the introducer sheath was cut open to verify all the pieces inside.The stent was stretched and separated in two pieces.The distal section was 4.3cm long and the proximal section was 7.5cm long.The proximal radiopaque marker was not found which indicates that part of the stent is missing.The inner liner was separated 6.8cm from the tip.There were scratch marks all over the tip of the device.There were multiple kinks along the inner liner.There was a kink to the outer sheath at the nosecone.Microscopic examination revealed no additional damages.The thumbwheel was functionally tested, and it was able to rotate freely.There is blood present inside the device.Inspection of the remainder of the device, revealed no other damage or irregularities.
 
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Brand Name
ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
Type of Device
STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9215853
MDR Text Key166419988
Report Number2134265-2019-12701
Device Sequence Number1
Product Code NIU
Combination Product (y/n)N
PMA/PMN Number
P180011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/18/2019
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 Number24653
Device Catalogue Number24653
Device Lot Number0023848277
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/25/2019
Initial Date Manufacturer Received 10/01/2019
Initial Date FDA Received10/21/2019
Supplement Dates Manufacturer Received11/14/2019
Supplement Dates FDA Received11/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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