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U.S. Department of Health and Human Services

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

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MEDTRONIC IRELAND RESOLUTE ONYX OTW STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number RONYX30015W
Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Patient Problem Injury (2348)
Event Date 01/15/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
A resolute onyx coronary drug eluting stent was attempted to be used to treat a moderately tortuous, severely calcified lesion in the proximal rca. The device was inspected with no issues noted. Negative prep was performed with no issues. It was reported that stent dislodgement occurred during removal following failed delivery. The patient was then sent to surgery to remove the dislodged stent.
 
Manufacturer Narrative
A review of the case notes was conducted by the account. There was no mention in the notes of the dislodged stent being in pieces. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Additional information: eval code-conclusion code added correction: adverse event and product problem selected intervention required ticked device code c62917 added if information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Additional information: the patient was brought back to the cath lab one day later to receive additional diagnostic imaging to locate the stent. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
It was reported that a piece of the stent broke off upon dislodging from the balloon. Carotid images were subsequently taken. The decision was made to take the patient to or for carotid exploration. The stent was unable to be located in the carotid. It was later determined that the piece of stent had migrated to the patients kidney. The patient was admitted for a laparoscopic procedure, however, the procedure was unsuccessful in retrieving the dislodged piece of stent. The stent piece remains in the patients kidney. The patient has since been discharged and is reportedly not experiencing any problems. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameRESOLUTE ONYX OTW
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 Key9630995
MDR Text Key176557533
Report Number9612164-2020-00409
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
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/12/2020
Device Model NumberRONYX30015W
Device Catalogue NumberRONYX30015W
Device Lot Number0009186613
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 Received04/16/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/13/2018
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: 01/27/2020 Patient Sequence Number: 1
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