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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); Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/22/2020
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: patient was over 18 years old.(b)(6).
 
Event Description
It was reported that the stent partially deployed and the delivery system became stuck on the guidewire.A 6x120x130 eluvia self expanding drug eluting stent was selected for an endovascular therapy (evt) procedure in the distal superficial femoral artery (sfa).A contralateral approach was used to access the non-tortuous and non-calcified lesion.However, the iliac bifurcation was significantly calcified, with a normal angle.Pre-dilation was successfully performed using a coyote 4x220 balloon reducing the 100% stenosis to create an approximately 4mm lumen.The stent was delivered with a non-bsc guiding sheath and non-bsc.014 inch guidewire.During deployment, the thumbwheel became stiff with about 6cm of the stent deployed.The pull grip was used to attempt to fully deploy the stent and another 5cm was deployed.The delivery system was stuck on the non-bsc guidewire.When the stent system was removed from the patient body together with the wire, the remainder of the stent was deployed.There was no stent stretching and no further stent needed to be deployed.After the device was removed, the handle was opened to analyze where the guidewire became stuck.No patient complications were reported.
 
Manufacturer Narrative
A2: age at time of event: patient was over 18 years old.E1: initial reporter city: (b)(6) device evaluated by mfr: returned product consisted of an eluvia self-expanding stent system with a.014" guidewire stuck inside.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the stent was missing.The rack was separated approximately 8.3cm from the distal end.The proximal end of the separation was missing.The handle was open, and the proximal inner has multiple kinks.Microscopic examination revealed no additional damages.Inspection of the remainder of the device, revealed no other damage or irregularities.
 
Event Description
It was reported that the stent partially deployed and the delivery system became stuck on the guidewire.A 6x120x130 eluvia self expanding drug eluting stent was selected for an endovascular therapy (evt) procedure in the distal superficial femoral artery (sfa).A contralateral approach was used to access the non-tortuous and non-calcified lesion.However, the iliac bifurcation was significantly calcified, with a normal angle.Pre-dilation was successfully performed using a coyote 4x220 balloon reducing the 100% stenosis to create an approximately 4mm lumen.The stent was delivered with a non-bsc guiding sheath and non-bsc.014 inch guidewire.During deployment, the thumbwheel became stiff with about 6cm of the stent deployed.The pull grip was used to attempt to fully deploy the stent and another 5cm was deployed.The delivery system was stuck on the non-bsc guidewire.When the stent system was removed from the patient body together with the wire, the remainder of the stent was deployed.There was no stent stretching and no further stent needed to be deployed.After the device was removed, the handle was opened to analyze where the guidewire became stuck.No patient complications were reported.
 
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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 Key10051938
MDR Text Key191115940
Report Number2134265-2020-06378
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 06/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/17/2021
Device Model Number24653
Device Catalogue Number24653
Device Lot Number0024046490
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/19/2020
Date Manufacturer Received06/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
COYOTE 4X220 BALLOON; COYOTE 4X220 BALLOON
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