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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 Problems Entrapment of Device (1212); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/16/2020
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.Initial reporter state: (b)(6).
 
Event Description
It was reported that the stent system became stuck on the wire during removal.The 75% stenosed target lesion was located in the severely calcified and moderately tortuous superficial femoral artery (sfa).The lesion was stenosed again six months after treatment with drug coated balloon (dcb).A 6x120x130 eluvia self expanding drug eluting stent and 0.035 non-bsc guidewire were selected for a lower extremity percutaneous transluminal angioplasty (pta) procedure in sfa.An ipsilateral approach was used to access the lesion.When trying to remove the system after stent was fully deployed, the user encountered difficulty with the wire and the system could not be removed.The system and wire had to be removed simultaneously from the patient body.Outside of the body, the physician tried to remove the system from the wire, but it could not be removed without applying considerable force, winding and pulling the wire with one hand.The wire moved when pushing it from the back of the system, but it could not be removed when trying to pull it.Then, it was forcibly pulled, and the wire was removed.It was noted that the eluvia system was kinked at the shaft, it occurred during retrieval.The procedure was successfully completed with this device.No patient complications were reported and the patient status post procedure was good.
 
Event Description
It was reported that the stent system became stuck on the wire during removal.The 75% stenosed target lesion was located in the severely calcified and moderately tortuous superficial femoral artery (sfa).The lesion was stenosed again six months after treatment with drug coated balloon (dcb).A 6x120x130 eluvia self expanding drug eluting stent and 0.035 non-bsc guidewire were selected for a lower extremity percutaneous transluminal angioplasty (pta) procedure in sfa.An ipsilateral approach was used to access the lesion.When trying to remove the system after stent was fully deployed, the user encountered difficulty with the wire and the system could not be removed.The system and wire had to be removed simultaneously from the patient body.Outside of the body, the physician tried to remove the system from the wire, but it could not be removed without applying considerable force, winding and pulling the wire with one hand.The wire moved when pushing it from the back of the system, but it could not be removed when trying to pull it.Then, it was forcibly pulled, and the wire was removed.It was noted that the eluvia system was kinked at the shaft, it occurred during retrieval.The procedure was successfully completed with this device.No patient complications were reported and the patient status post procedure was good.
 
Manufacturer Narrative
A2: age at time of event: 18 years or older.E1: initial reporter state: aichi prefecture.Device evaluated by mfr: returned product consisted of an eluvia 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.There was multiple buckling to the middle sheath.There was buckling to the inner liner 2.3cm from the tip.Microscopic examination revealed no additional damages.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 Key10257811
MDR Text Key198334448
Report Number2134265-2020-08837
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 08/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/13/2021
Device Model Number24653
Device Catalogue Number24653
Device Lot Number0023485385
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/07/2020
Date Manufacturer Received07/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
TERUMO - RADIFOCUS 0.035" GUIDE CATHETER; TERUMO - RADIFOCUS 0.035" GUIDE CATHETER; TERUMO - RADIFOCUS 0.035" GUIDE CATHETER.
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