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U.S. Department of Health and Human Services

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

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MEDTRONIC IRELAND RESOLUTE ONYX RX CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number RONYX27518UX
Device Problems Migration or Expulsion of Device (1395); Inadequacy of Device Shape and/or Size (1583)
Patient Problems Obstruction/Occlusion (2422); Insufficient Information (4580)
Event Date 03/09/2022
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Two resolute onyx coronary drug eluting stents were implanted to treat a non-tortuous lesion in the mid right coronary artery (rca). The devices were inspected with no issues noted. The mid-distal rca was pre-dilated with a semi compliant balloon. The devices did not pass through a previously deployed stent. Resistance was not encountered when advancing the devices and excessive force was not used during delivery.   it was reported that the first stent was deployed and then migrated to the proximal rca. The migrated stent was then post-dilated and secured using an nc balloon. The second stent was deployed in the original lesion site but this stent also migrated, distally. Both stents were secured after successive nc dilation. A third resolute onyx stent was then placed between the first two stents. No further patient injury reported.
 
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Brand NameRESOLUTE ONYX RX
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer Contact
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key13840052
MDR Text Key287539965
Report Number9612164-2022-01089
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberRONYX27518UX
Device Catalogue NumberRONYX27518UX
Device Lot Number0010601582
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/04/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/19/2021
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: 03/21/2022 Patient Sequence Number: 1
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