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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
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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 Positioning Failure (1158); Fracture (1260); Stretched (1601)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/17/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
 
Event Description
It was reported that stent damage and deployment difficulties occurred.The target lesion was located in a heavily calcified, long segment occlusion of the left superficial femoral artery (sfa).The lesion was prepared with predilation using a balloon catheter and a scoring balloon catheter.A 6x150 130 cm eluvia¿ drug-eluting vascular stent system was advanced contralaterally to the sfa and was able to deploy 1cm of the stent with the thumb wheel when deployment failed.The physician then "cut off the control handle" and tried to manually deploy the stent however this also failed.The eluvia¿ system was removed by advancing a 7 french, 90cm sheath over the eluvia¿ system and partially deployed stent.The system was removed and a distal part of the stent was damaged and elongated.A small piece of the stent broke and was trapped by a 6mm balloon.The procedure was completed with the deployment of 6 x 150 mm and 7 x 100 eluvia¿ stents overlapping in the occluded segment of the sfa.The procedure results "showed nicely run off." there were no patient complications reported and the patient's status was stable.
 
Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an eluvia self-expanding stent delivery system (sds).The outer shaft, middle shaft, inner shaft and the remainder of the device were checked for damage.The outer sheath, middle shaft and the proximal inner shaft were all separated from the device when received.The sheath showed buckling/damage approximately 30 to 31.5cm from the separated area.The outer sheath also showed 2 kinks, one at 21.5cm from the marker band and the other at 23.5cm from the marker band.The handle was opened when returned and multiple components were missing.The nosecone was not returned.The retainer clip from inside of the handle was not returned.The pull handle was completely separated from the handle.The stent was returned in the device; however, it was partially deployed approximately 12mm from the marker band and damaged.The handle was opened and it was noticed that the thumb wheel had gear damage.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.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 stent damage and deployment difficulties occurred.The target lesion was located in a heavily calcified, long segment occlusion of the left superficial femoral artery (sfa).The lesion was prepared with predilation using a balloon catheter and a scoring balloon catheter.A 6x150 130 cm eluvia¿ drug-eluting vascular stent system was advanced contralaterally to the sfa and was able to deploy 1cm of the stent with the thumb wheel when deployment failed.The physician then "cut off the control handle" and tried to manually deploy the stent however this also failed.The eluvia¿ system was removed by advancing a 7 french, 90cm sheath over the eluvia¿ system and partially deployed stent.The system was removed and a distal part of the stent was damaged and elongated.A small piece of the stent broke and was trapped by a 6mm balloon.The procedure was completed with the deployment of 6 x 150 mm and 7 x 100 eluvia¿ stents overlapping in the occluded segment of the sfa.The procedure results "showed nicely run off." there were no patient complications reported and the patient's status was stable.
 
Manufacturer Narrative
Device evaluated by mfr.: the root cause has been corrected from operational context to undeterminable.The most probable root cause was unable to be determined (b)(4).
 
Event Description
It was reported that stent damage and deployment difficulties occurred.The target lesion was located in a heavily calcified, long segment occlusion of the left superficial femoral artery (sfa).The lesion was prepared with predilation using a balloon catheter and a scoring balloon catheter.A 6x150 130 cm eluvia¿ drug-eluting vascular stent system was advanced contralaterally to the sfa and was able to deploy 1cm of the stent with the thumb wheel when deployment failed.The physician then "cut off the control handle" and tried to manually deploy the stent however this also failed.The eluvia¿ system was removed by advancing a 7 french, 90cm sheath over the eluvia¿ system and partially deployed stent.The system was removed and a distal part of the stent was damaged and elongated.A small piece of the stent broke and was trapped by a 6mm balloon.The procedure was completed with the deployment of 6 x 150 mm and 7 x 100 eluvia¿ stents overlapping in the occluded segment of the sfa.The procedure results "showed nicely run off." there were no patient complications reported and the patient's status was stable.
 
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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 - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6393686
MDR Text Key69556027
Report Number2134265-2017-01862
Device Sequence Number1
Product Code NIU
Combination Product (y/n)N
Reporter Country CodeTH
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,Followup
Report Date 02/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2018
Device Model NumberH74939295601510
Device Catalogue Number39295-60151
Device Lot Number19794742
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/24/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ACCESS SHEATH: BIOTRONIK 6FR FORTRESS 45CM; GUIDE WIRE: TERUMO GLIDEWIRE .035
Patient Outcome(s) Required Intervention;
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