Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE ELUVIA¿ DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC - MAPLE GROVE ELUVIA¿ DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING Back to Search Results
Model Number H74939295601510
Device Problems Difficult or Delayed Positioning (1157); Stretched (1601)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/24/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(6).Device is a combination product.Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr: the device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).
 
Event Description
It was reported that deployment difficulties occurred.The calcified target lesion was located in the occluded superficial femoral artery (sfa).A 6x150mm eluvia¿ drug-eluting vascular stent system was advanced to the sfa via the cross-over approach.During deployment, the deployment mechanism stopped working after 15cm of the eluvia stent was expanded, and the stent stretched to 20cm.The issue occurred at about 95% deployment and after switching to the pull grip mechanism for deployment.In order to complete the implant of the eluvia stent there were "some higher forces needed to advance the procedure" and the handle was "dismounted." the stent was eventually implanted and "fully enlarged." the distal and proximal marker bands were visualized on radiogram and the procedure was completed with this device.There were no patient complications reported and the patient's status was stable.
 
Manufacturer Narrative
Date of birth: 1969.(b)(4).
 
Event Description
It was reported that deployment difficulties occurred.The calcified target lesion was located in the occluded superficial femoral artery (sfa).A 6x150mm eluvia¿ drug-eluting vascular stent system was advanced to the sfa via the cross-over approach.During deployment, the deployment mechanism stopped working after 15cm of the eluvia stent was expanded, and the stent stretched to 20cm.The issue occurred at about 95% deployment and after switching to the pull grip mechanism for deployment.In order to complete the implant of the eluvia stent there were "some higher forces needed to advance the procedure" and the handle was "dismounted." the stent was eventually implanted and "fully enlarged." the distal and proximal marker bands were visualized on radiogram and the procedure was completed with this device.There were no patient complications reported and the patient's status was stable.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ELUVIA¿ DRUG-ELUTING VASCULAR STENT SYSTEM
Type of Device
STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6187660
MDR Text Key62790539
Report Number2134265-2016-11736
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,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2017
Device Model NumberH74939295601510
Device Catalogue Number39295-60151
Device Lot Number19437920
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/11/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/13/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-