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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
Catalog Number RONYX30012UX
Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Event Date 06/11/2018
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 intended to be used to treat a non-tortuous and moderately calcified lesion with 80% stenosis in the mid rca. There was no damage noted to the device packaging. There were no issues removing the device from the hoop. The device was not inspected. Negative prep was performed with no issues. The lesion was pre-dilated. The device did not pass through a previously deployed stent. Resistance was not encountered when advancing the device. Excessive force was not used during delivery. It was reported that stent dislodgement occurred during an attempted deployment. An angioplasty of the distal rca was performed prior to the stent dislodgement. The stent was not removed. No patient injury is reported.

 
Manufacturer Narrative

No difficulties noted when removing the protective sheath. The inflation device remain on neutral pressure during delivery of the device. An attempt was made to snare the dislodged stent but it was unsuccessful. The stent was lost in the patient anatomy. The angioplasty of the distal rca had no effect on the dislodgement of the stent. If information is provided in the future, a supplemental report will be issued.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
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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 Key7669082
MDR Text Key113631421
Report Number9612164-2018-01659
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP160043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 10/22/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/09/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/16/2020
Device Catalogue NumberRONYX30012UX
Device LOT Number0008954928
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 Received10/02/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/16/2018
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: 07/09/2018 Patient Sequence Number: 1
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