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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 Failure to Advance (2524); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/10/2020
Event Type  malfunction  
Manufacturer Narrative
Device is combination product.(b)(6).
 
Event Description
It was reported that the shaft was separated.A 6x80, 130 cm eluvia drug-eluting vascular stent system was selected for use.The device was unable to cross the lesion.After the device was removed outside the body, it was observed that the outer shaft covering the stent was separated from the tip of the shaft.The handle had already been rotated approximately one to two times.The procedure was completed with a different device.There were no patient complications reported.
 
Event Description
It was reported that the shaft was separated.A 6x80, 130 cm eluvia drug-eluting vascular stent system was selected for use.The device was unable to cross the lesion.After the device was removed outside the body, it was observed that the outer shaft covering the stent was separated from the tip of the shaft.The handle had already been rotated approximately one to two times.The procedure was completed with a different device.There were no patient complications reported.It was further reported that vascular access was obtained via contralateral antegrade approach.The target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery.The lesion was predilated with a 4mmx300mm non-bsc device.The patient's status was good post procedure.
 
Manufacturer Narrative
Device is combination product.E1: initial reporter state: (b)(6).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 that the outer sheath is damaged at the distal tip.Microscopic examination revealed no additional damages.The middle sheath is no longer sitting on top of the distal tip.Inspection of the remainder of the device presented 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 Key9896149
MDR Text Key185664054
Report Number2134265-2020-04041
Device Sequence Number1
Product Code NIU
Combination Product (y/n)N
PMA/PMN Number
SIMILAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 04/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/06/2021
Device Model Number24653
Device Catalogue Number24653
Device Lot Number0023633476
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/25/2020
Date Manufacturer Received04/01/2020
Patient Sequence Number1
Treatment
GUIDE SHEATH: TERUMO, DESTINATION 45 CM; GUIDEWIRE: TERUMO, RADIFOCUS 0.035 INCH, 300 CM
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