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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 H74939295601070
Device Problems Bent (1059); Detachment Of Device Component (1104); Entrapment of Device (1212); Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 04/05/2017
Event Type  Injury  
Manufacturer Narrative
Age at time of event: 18 years or older.Device is combination product.(b)(4).Device evaluated by mfr.: the device was not returned 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 stent deployment issues occurred, the stent elongated, the tip detached, and it was difficult to remove the delivery system.The target lesion was located in the totally occluded minimally calcified superficial femoral artery (sfa).The lesion was predilated and a contralateral approach was used to access the lesion.A 6x100 75 cm eluvia¿ drug-eluting vascular stent system was selected for the procedure.Upon stent deployment, the proximal part of the stent remained attached to the unspecified 45cm 6fr delivery sheath.When the delivery system was attempted to be removed, it became stuck.The delivery system was pulled very hard and the stent released.Due to the stent being trapped in the sheath when removal was performed, the stent elongated from 100mm to 200mm and became damaged.After removal, it was noticed that the tip of the delivery catheter was missing.The tip was located further down in the sfa.Another stent was deployed in the distal sfa to jail the tip of the delivery system.An additional stent was placed at the proximal end of the eluvia stent to keep it open due to the damage.The procedure was completed and the vessel was patent.No further complications were reported.The patient's condition was noted as stable.
 
Manufacturer Narrative
Age at time of event: 50s.(b)(4).
 
Event Description
It was reported that stent deployment issues occurred, the stent elongated, the tip detached, and it was difficult to remove the delivery system.The target lesion was located in the totally occluded minimally calcified superficial femoral artery (sfa).The lesion was predilated and a contralateral approach was used to access the lesion.A 6x100 75 cm eluvia¿ drug-eluting vascular stent system was selected for the procedure.Upon stent deployment, the proximal part of the stent remained attached to the unspecified 45cm 6fr delivery sheath.When the delivery system was attempted to be removed, it became stuck.The delivery system was pulled very hard and the stent released.Due to the stent being trapped in the sheath when removal was performed, the stent elongated from 100mm to 200mm and became damaged.After removal, it was noticed that the tip of the delivery catheter was missing.The tip was located further down in the sfa.Another stent was deployed in the distal sfa to jail the tip of the delivery system.An additional stent was placed at the proximal end of the eluvia stent to keep it open due to the damage.The procedure was completed and the vessel was patent.No further complications were reported.The patient's condition was noted as 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 Key6522525
MDR Text Key73722732
Report Number2134265-2017-03881
Device Sequence Number1
Product Code NIU
Combination Product (y/n)N
Reporter Country CodeAU
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 04/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2017
Device Model NumberH74939295601070
Device Catalogue Number39295-60107
Device Lot Number19325007
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/30/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/08/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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