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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 Break (1069); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Patient Problem No Code Available (3191)
Event Date 07/31/2019
Event Type  Injury  
Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event Description
It was reported that the stent partially deployed and elongated.The 99% stenosed 300mm target lesion was located in the severely calcified and severely tortuous left superficial femoral artery (sfa).Vascular access was obtained from the right femoral artery with a 45cm long 6f plastic introducer.A 0.035x260cm zipwire hydrophilic guidewire was advanced contralateral and the pre-dilatation was performed with a 6x150x130 mustang dilatation balloon catheter.Post pre-dilatation, the lesion was 85% stenosed.A 6x120x130 eluvia drug-eluting vascular stent system was selected for use.The stent was flushed from the back after unpacking.The stent was advanced and there was a lot of resistance and difficulty to get the device though the iliac to achieve lateral positioning.The stent was positioned in the left sfa and deployment was initiated with the thumbwheel.In the beginning, the movement of the thumbwheel was normal, then it became very difficult to move.Thirty percent of the stent was deployed at this time.A 'click' was heard and the pull grip was attempted to use to finish releasing the stent, but the delivery system broke.The stent became elongated and had distal edge compression.The stent deployment could not be completed.After the procedure, it was noted that there was a kink in the external part of the blue triaxial mechanism.Four hours of open surgery were completed to extract the stent.The stent was successfully removed and the stent broke after removal.The patient was stable post procedure.The patient was hospitalized for two days to monitor progress and assess for possible amputation.The patient remained stable three days post procedure, did not require an amputation, and was discharged from the hospital.
 
Manufacturer Narrative
Age at time of event: 18 years or older device evaluated by mfr: the returned product consisted of an eluvia self-expanding stent system stuck on what appeared to be a 0.035" zipwire.An introducer sheath was also returned with the device.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the stent was separated in two pieces outside of the device and appeared to have been stretched.The pieces were 4.2cm and 1.7cm long.The middle sheath was separated 19.2cm from the distal end of the outer sheath.There was multiple buckling along the outer sheath.Microscopic examination revealed that the inner liner was separated approximately 6mm from the distal end of the proximal inner.The proximal inner had surface damage 5mm from the distal end of the proximal inner.The introducer sheath that returned with the eluvia device was visually inspected and x-rayed.There were multiple kinks on the introducer sheath.The introducer sheath was x-rayed, and the separated sections were inside the introducer sheath.The separated middle sheath was clearly seen.The radiopaque markers of the stent can be seen, and the stent was stretched at the distal section of the sheath.The tip of the eluvia device was seen inside the sheath.There was no damage on the handle of the device.
 
Event Description
It was reported that the stent partially deployed and elongated.The 99% stenosed 300mm target lesion was located in the severely calcified and severely tortuous left superficial femoral artery (sfa).Vascular access was obtained from the right femoral artery with a 45cm long 6f plastic introducer.A 0.035x260cm zipwire hydrophilic guidewire was advanced contralateral and the pre-dilatation was performed with a 6x150x130 mustang dilatation balloon catheter.Post pre-dilatation, the lesion was 85% stenosed.A 6x120x130 eluvia drug-eluting vascular stent system was selected for use.The stent was flushed from the back after unpacking.The stent was advanced and there was a lot of resistance and difficulty to get the device though the iliac to achieve lateral positioning.The stent was positioned in the left sfa and deployment was initiated with the thumbwheel.In the beginning, the movement of the thumbwheel was normal, then it became very difficult to move.Thirty percent of the stent was deployed at this time.A 'click' was heard and the pull grip was attempted to use to finish releasing the stent, but the delivery system broke.The stent became elongated and had distal edge compression.The stent deployment could not be completed.After the procedure, it was noted that there was a kink in the external part of the blue triaxial mechanism.Four hours of open surgery were completed to extract the stent.The stent was successfully removed and the stent broke after removal.The patient was stable post procedure.The patient was hospitalized for two days to monitor progress and assess for possible amputation.The patient remained stable three days post procedure, did not require an amputation, and was discharged from the hospital.It was further reported that the zipwire was used without issue during the procedure and everything was ok with the zipwire device.
 
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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 Key8901393
MDR Text Key154556749
Report Number2134265-2019-09783
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 09/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/13/2019
Device Model Number24653
Device Catalogue Number24653
Device Lot Number0022154640
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/30/2019
Date Manufacturer Received09/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
6X150X130 MUSTANG DILATATION BALLOON CATHETER; 6X150X130 MUSTANG DILATATION BALLOON CATHETER; CORDIS 6F LONG SHEATH; CORDIS 6F LONG SHEATH; ZIPWIRE HYDROPHILIC GUIDE .035 "X260CM; ZIPWIRE HYDROPHILIC GUIDE .035 "X260CM; 6X150X130 MUSTANG DILATATION BALLOON CATHETER; CORDIS 6F LONG SHEATH; ZIPWIRE HYDROPHILIC GUIDE .035 "X260CM
Patient Outcome(s) Required Intervention;
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