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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 or Delayed Positioning (1157); Positioning Problem (3009)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/21/2018
Event Type  malfunction  
Event Description
It was reported the stent was improperly positioned.A 6x120 eluvia drug-eluting vascular stent system was selected for use.The stent was advanced to the target lesion and deployment initiated.The stent deployed fine until the last 3cm.At this point, resistance was felt during deployment and it was felt that the thumbwheel movement was not unsheathing the stent as expected.The physician rolled the thumbwheel additional times to get the stent to completely deploy.The final position of the stent was not optimal as the stent was intended to be flush with the bifurcation but ended up 5mm lower than the bifurcation.Blood flow was not obstructed and no additional intervention was required to the stent.The procedure was completed with this device.There were no patient complications and the patient's condition was noted to be stable.
 
Event Description
It was reported the stent was improperly positioned.A 6x120 eluvia drug-eluting vascular stent system was selected for use.The stent was advanced to the target lesion and deployment initiated.The stent deployed fine until the last 3cm.At this point, resistance was felt during deployment and it was felt that the thumbwheel movement was not unsheathing the stent as expected.The physician rolled the thumbwheel additional times to get the stent to completely deploy.The final position of the stent was not optimal as the stent was intended to be flush with the bifurcation but ended up 5mm lower than the bifurcation.Blood flow was not obstructed and no additional intervention was required to the stent.The procedure was completed with this device.There were no patient complications and the patient's condition was noted to be stable.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 a kink at the nosecone and another kink on the inner liner 73mm from the tip.The stent was not returned with the device.The rack was fully extended.There is blood present on the inner liner, proximal inner, and middle sheath.Inspection of the remainder of the device, revealed no other damage or irregularities.Product analysis was also conducted by operations engineering.Operations engineering opened the handle and no abnormalities were noticed.Operations engineering measured the proximal inner and it was at the target length of 143.6cm.
 
Manufacturer Narrative
Device is a combination product.This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/17/2018 01:46 pm ct.The report number is being corrected from: 2134265-2018-64424 to: 2134265-2018-63598.
 
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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 Key8152796
MDR Text Key130042323
Report Number2134265-2018-63598
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 01/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/16/2019
Device Model Number24653
Device Catalogue Number24653
Device Lot Number0022326837
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2018
Initial Date Manufacturer Received 11/21/2018
Initial Date FDA Received12/11/2018
Supplement Dates Manufacturer Received12/14/2018
Supplement Dates FDA Received01/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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