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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING

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MEDTRONIC IRELAND RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number RONYX35038UX
Device Problems Burst Container or Vessel (1074); Activation, Positioning or SeparationProblem (2906); Device Dislodged or Dislocated (2923)
Patient Problems Intimal Dissection (1333); Vascular Dissection (3160)
Event Date 08/02/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
One resolute onyx drug eluting stent was attempted to be used to treat a moderately calcified lesion in a moderately tortuous vessel. There was no damage noted to the device packaging. The device was inspected with no issues noted. The lesion was pre-dilated. The device did not pass through a previously deployed stent. Resistance was not encountered when advancing the device and excessive force was not used. It was reported that a balloon rupture occurred during stent deployment, but it was unknown where the burst/leak occurred. The balloon rupture resulted in partial deployment of the stent. It was stated that the removal of the ruptured balloon resulted in stent dislodgement of the partially deployed stent and a coronary artery dissection. It was indicated that stent dislodgement occurred after removal of the device from the patient. No further patient injury reported. The procedure was completed using another resolute onyx device.
 
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Brand NameRESOLUTE ONYX RX
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key10435719
MDR Text Key203799715
Report Number9612164-2020-03069
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P160043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 11/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/17/2021
Device Model NumberRONYX35038UX
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
Date Manufacturer Received11/27/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/18/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/21/2020 Patient Sequence Number: 1
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