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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC EV3 SPIDERFX; EMBOLIC PROTECTION DEVICE, SPD
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MEDTRONIC EV3 SPIDERFX; EMBOLIC PROTECTION DEVICE, SPD Back to Search Results
Model Number SPD2
Device Problems Migration or Expulsion of Device (1395); Material Separation (1562)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 03/19/2018
Event Type  Injury  
Event Description
Spider ex embolic protection device was placed in a vg to distal rca in the standard fashion.After few minutes the operator realized that the tip of the spiderfx migrated down the small branch of distal rca.The spiderfx was then removed and the position of the separated tip was confirmed with ivus images.A coronary stent was placed in distal rca to cover the atherosclerotic lesion of the artery and to secure the tip of the spiderfx against the wall of the vessel so it does not migrate any further.The appropriate position of the stent and the spiderfx tip were confirmed with ivus images at the end of the procedure.
 
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Brand Name
SPIDERFX
Type of Device
EMBOLIC PROTECTION DEVICE, SPD
Manufacturer (Section D)
MEDTRONIC EV3
plymouth ME 55442
MDR Report Key7411236
MDR Text Key105198157
Report NumberMW5076378
Device Sequence Number1
Product Code NTE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/12/2019
Device Model NumberSPD2
Device Catalogue NumberSPD2-US-040-320
Device Lot NumberA565078
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age63 YR
Patient Weight82
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