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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 Detachment of Device or Device Component (2907)
Patient Problems Thrombosis (2100); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Thrombosis/Thrombus (4440)
Event Date 01/14/2021
Event Type  Injury  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the tip of the delivery system detached and remained in the blood vessel, resulting in thrombosis.A 6mm x 80mm x 130cm and a 6mm x 40mm x 130cm eluvia drug-eluting vascular stent system were selected for use in a stenting procedure within the right superficial femoral artery to treat peripheral artery disease.A 0.035 inch non-boston scientific guidewire was used in this procedure.During the procedure, the tip of the distally implanted eluvia delivery system separated.The stents overlapped and were placed without issue.Post-dilation was performed three times by balloon.At that time, there was a black shadow in the blood vessel, which seemed to be thrombus.When checking the tip of the delivery system for the eluvia placed distally, the tip was found to be separated.The tip likely remained in the blood vessel.The day after the procedure, thrombosis was confirmed in both eluvia stents and treated that same day.
 
Manufacturer Narrative
E1: initial reporter address 1: (b)(6).Device eval by manufacturer: 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.The tip was separated from the inner liner and was missing.Microscopic examination revealed no additional damages.Inspection of the remainder of the device revealed no other damage or irregularities.Product analysis confirmed the tip was missing.
 
Event Description
It was reported that the tip of the delivery system detached and remained in the blood vessel, resulting in thrombosis.A 6mm x 80mm x 130cm and a 6mm x 40mm x 130cm eluvia drug-eluting vascular stent system were selected for use in a stenting procedure within the right superficial femoral artery to treat peripheral artery disease.A 0.035 inch non-boston scientific guidewire was used in this procedure.During the procedure, the tip of the distally implanted eluvia delivery system separated.The stents overlapped and were placed without issue.Post-dilation was performed three times by balloon.At that time, there was a black shadow in the blood vessel, which seemed to be thrombus.When checking the tip of the delivery system for the eluvia placed distally, the tip was found to be separated.The tip likely remained in the blood vessel.The day after the procedure, thrombosis was confirmed in both eluvia stents and treated that same day.
 
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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 Key11231392
MDR Text Key228740317
Report Number2134265-2021-00750
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 03/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/03/2021
Device Model Number24653
Device Catalogue Number24653
Device Lot Number0023687283
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2021
Date Manufacturer Received02/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
TERUMO RADIFOCUS GUIDEWIRE; TERUMO RADIFOCUS GUIDEWIRE; TERUMO RADIFOCUS GUIDEWIRE
Patient Outcome(s) Required Intervention;
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