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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 Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 03/12/2019
Event Type  Injury  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that the tip of the device broke off and a snare was used to remove it from the patient.A 7x120x130 eluvia drug-eluting vascular stent system was selected for a superficial femoral artery (sfa) angioplasty procedure.A non bsc 7f guide sheath was used.The aortic arch was steep, but not broad.During insertion, resistance was felt, but not too excessive.The stent deployed ok, but resistance was felt upon removal.The tip of the delivery system broke off and the outer shaft was stripped.The physician made a popliteal puncture and snared the tip which was stuck on the wire.The entire system was removed with difficulty and a significant amount of time.There were no patient complications reported.
 
Manufacturer Narrative
Device is a combination product.Device evaluated by mfr: the stent was implanted and did not return for product analysis.Returned product consisted of an eluvia self-expanding stent system stuck inside what appeared to be the reported cook 7f anl guide sheath.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the inner liner was separated 16mm from the tip and appeared to have been stretched prior to separating.The rack was separated 13.7cm from the knob.There was approximately 7mm of the rack sticking out of the handle.There was a kink to the outer sheath at the nosecone.Microscopic examination revealed no additional damages.There was blood present on and in the device.The guide wire used in the clinical procedure was not returned with the device so a.035 test guide wire was used for functional testing, which revealed the wire advanced through the inner liner and was able to pass through the device.Due to severe damages on the non-bsc guide sheath, it could not be removed from the stent system.There were multiple buckles to the outer sheath, scratch marks along the sheath, part of the coil was pulled out of the distal end, and the ptfe liner was pulled out the distal end in strips.Inspection of the remainder of the device, revealed no other damage or irregularities.Product analysis confirmed the inner liner was separated.Analysis also found that the inner liner appeared to have been stretched, which suggests it could have contributed to the reported difficulty to remove and froze on wire.The reported shaft stripped, and concertina (buckling) was noticed on the competitor's device and not on the bsc device.
 
Event Description
It was reported that the tip of the device broke off and a snare was used to remove it from the patient.A 7x120x130 eluvia drug-eluting vascular stent system was selected for a superficial femoral artery (sfa) angioplasty procedure.A non bsc 7f guide sheath was used.The aortic arch was steep, but not broad.During insertion, resistance was felt, but not too excessive.The stent deployed ok, but resistance was felt upon removal.The tip of the delivery system broke off and the outer shaft was stripped.The physician made a popliteal puncture and snared the tip which was stuck on the wire.The entire system was removed with difficulty and a significant amount of time.There were no patient complications 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 Key8491526
MDR Text Key141197909
Report Number2134265-2019-03523
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 05/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/06/2019
Device Model Number24653
Device Catalogue Number24653
Device Lot Number0021474986
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2019
Date Manufacturer Received04/26/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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