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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC VASCULAR RESOLUTE ONYX RX 3.5X38MM CORONARY DRUG-ELUTING STENT

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MEDTRONIC VASCULAR RESOLUTE ONYX RX 3.5X38MM CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number RESOLUTE ONYX RX DES
Device Problems Material Rupture (1546); Activation, Positioning or SeparationProblem (2906); Device Dislodged or Dislocated (2923)
Patient Problem Vascular Dissection (3160)
Event Date 08/02/2020
Event Type  Injury  
Event Description
During a coronary stent implant, the delivery balloon ruptured at 8 atm. Balloon rupture resulted in partial deployment. Removal of ruptured balloon resulted in dislodgment of partially deployed stent from the coronary artery and coronary artery dissection. Fda safety report id# (b)(4).
 
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Brand NameRESOLUTE ONYX RX 3.5X38MM
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
MEDTRONIC VASCULAR
MDR Report Key10413084
MDR Text Key203290882
Report NumberMW5096080
Device Sequence Number1
Product Code NIQ
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 08/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/17/2021
Device Model NumberRESOLUTE ONYX RX DES
Device Catalogue NumberRONYX35038UX
Device Lot Number0009926856
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/14/2020 Patient Sequence Number: 1
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