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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 Entrapment of Device (1212)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/23/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the delivery system became stuck on the wire.The 100% stenosed target lesion was located in the moderately tortuous superficial femoral artery (sfa).A 7x120x130 eluvia drug-eluting vascular stent system was selected for the procedure.The stent was deployed.Upon removal, the delivery system became stuck on the wire.The delivery system and the wire were removed together.There were no patient complications reported and the patient's status was good post procedure.
 
Event Description
It was reported that the delivery system became stuck on the wire.The 100% stenosed target lesion was located in the moderately tortuous superficial femoral artery (sfa).A 7x120x130 eluvia drug-eluting vascular stent system was selected for the procedure.The stent was deployed.Upon removal, the delivery system became stuck on the wire.The delivery system and the wire were removed together.There were no patient complications reported and the patient was good post procedure.
 
Manufacturer Narrative
Initial reporter city: (b)(6).Device evaluated by mfr: returned product consisted of an eluvia self-expanding stent system with a 0.014" guidewire stuck in the device.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 device was x-ray and the proximal inner was prolapsed.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 Key10251853
MDR Text Key198162045
Report Number2134265-2020-09050
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,distri
Type of Report Initial,Followup
Report Date 08/11/2020
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 Expiration Date10/01/2021
Device Model Number24653
Device Catalogue Number24653
Device Lot Number0024595459
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2020
Initial Date Manufacturer Received 06/23/2020
Initial Date FDA Received07/09/2020
Supplement Dates Manufacturer Received07/30/2020
Supplement Dates FDA Received08/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
6F DESTINATION INTRODUCER SHEATH; 6F DESTINATION INTRODUCER SHEATH; GLADIUS GUIDEWIRE; GLADIUS GUIDEWIRE; 6F DESTINATION INTRODUCER SHEATH; GLADIUS GUIDEWIRE
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