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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); Difficult or Delayed Activation (2577)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/04/2019
Event Type  malfunction  
Manufacturer Narrative
Initial reporter city: (b)(6).
 
Event Description
It was reported that the device became entrapped on the guidewire.A 6 x 120 x 130 cm eluvia drug-eluting vascular stent was selected to be implanted in the 100% stenosed superficial femoral artery (sfa).The tortuosity and calcification of the lesion in the sfa were characterized as moderate.Vascular access to the sfa was obtained via a contralateral approach using a non-bsc sheath.The sheath was inserted into the back of the knee, and the procedure was performed by securing two routes.The stent was successfully advanced to the lesion using an aguru support 300cm guidewire and then deployed.It was noted that the pull grip was hard and not normal.However, the stent was still able to be deployed successfully.The delivery system was then attempted to be removed.However, it could not be removed and no irregularities to the device were seen on fluoroscopy.The entire system was then removed from the patient.It was observed that the guidewire was stuck in the wire lumen of the delivery system.
 
Event Description
It was reported that the device became entrapped on the guidewire.A 6 x 120 x 130 cm eluvia drug-eluting vascular stent was selected to be implanted in the 100% stenosed superficial femoral artery (sfa).The tortuosity and calcification of the lesion in the sfa were characterized as moderate.Vascular access to the sfa was obtained via a contralateral approach using a non-bsc sheath.The sheath was inserted into the back of the knee, and the procedure was performed by securing two routes.The stent was successfully advanced to the lesion using an aguru support 300cm guidewire and then deployed.It was noted that the pull grip was hard and not normal.However, the stent was still able to be deployed successfully.The delivery system was then attempted to be removed.However, it could not be removed and no irregularities to the device were seen on fluoroscopy.The entire system was then removed from the patient.It was observed that the guidewire was stuck in the wire lumen of the delivery system.
 
Manufacturer Narrative
E1: initial reporter city: (b)(6) device evaluation by mfr: the returned product consisted of an eluvia self-expanding stent system with a 0.014 guidewire stuck in the device.Visual examination revealed buckling to the outer sheath at 63.2cm, 65.2cm, and 66.3cm from the tip.Microscopic examination revealed damage to the tip.The stent was deployed and did not return for analysis.The handle was opened, and the proximal inner can be seen 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 Key9484810
MDR Text Key176637044
Report Number2134265-2019-15893
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 01/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/21/2021
Device Model Number24653
Device Catalogue Number24653
Device Lot Number0023518599
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/23/2019
Date Manufacturer Received01/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
TERUMO DESTINATION GUIDING SHEATH; TERUMO DESTINATION GUIDING SHEATH
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