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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 Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/18/2022
Event Type  malfunction  
Event Description
It was reported that stent partial deployment occurred.The chronic totally occluded target lesion was located in the moderately tortuous and severely calcified left superficial femoral artery.A 7x120x130cm eluvia self-expanding stent was selected for use.Treatment of the total occlusion was done using a contralateral approach because ipsilateral puncture was not possible.The patient had a history of endovascular therapy for iliac disease, so three stents had already been placed.Because of this, and due to the severe tortuosity, it was decided that the guide catheter could not be advanced alone.Following pre-dilation, an eluvia was requested to be placed using a.035 guidewire in advance, but a jupiter wire was selected "accidentally".As the stent was being deployed, the wire became entrapped in the handle and prevented the stent from being deployed halfway through.The physician broke the handle to successfully complete stent deployment in the target location.No patient complications were reported.
 
Manufacturer Narrative
(b)(6).
 
Manufacturer Narrative
E1: initial reporter facility name: (b)(6).Analysis by manufacturer: 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 the eluvia was returned in several pieces as the handle had been broken open and the wheel had separated from the handle.The stent was not returned.Microscopic examination found a kink 4 mm from the nosecone and another kink 11.6 cm from the nosecone.Because there was no evidence of any product quality deficiencies, it was considered likely that the kinks were attributable to handling.
 
Event Description
It was reported that stent partial deployment occurred.The chronic totally occluded target lesion was located in the moderately tortuous and severely calcified left superficial femoral artery.A 7x120x130cm eluvia self-expanding stent was selected for use.Treatment of the total occlusion was done using a contralateral approach because ipsilateral puncture was not possible.The patient had a history of endovascular therapy for iliac disease, so three stents had already been placed.Because of this, and due to the severe tortuosity, it was decided that the guide catheter could not be advanced alone.Following pre-dilation, an eluvia was requested to be placed using a.035 guidewire in advance, but a jupiter wire was selected "accidentally".As the stent was being deployed, the wire became entrapped in the handle and prevented the stent from being deployed halfway through.The physician broke the handle to successfully complete stent deployment in the target location.No patient complications were 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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key14091681
MDR Text Key289187726
Report Number2134265-2022-04236
Device Sequence Number1
Product Code NIU
Combination Product (y/n)Y
Reporter Country CodeJA
PMA/PMN Number
P180011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/26/2023
Device Model Number24653
Device Catalogue Number24653
Device Lot Number0028059665
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/05/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/26/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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