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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 RONYX22530UX
Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Device Damaged by Another Device (2915); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)
Event Date 01/13/2020
Event Type  malfunction  
Manufacturer Narrative
Product analysis summary: device returned for evaluation. Two dislodged stents returned for analysis, 2. 25 x 30 resolute onyx (pli 10) and 2. 25 x 38mm resolute onyx (pli 20). Extensive deformation was evident to stents with struts severely stretched. Fracture points were evident to the stent wires. It was not possible to identify pli 10 or 20 due to the deformation. 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.
 
Event Description
A 2. 25 x 30 resolute onyx rx coronary, drug eluting stent (pli10) was used to treat a severely calcified, mildly tortuosity lesion exhibiting 80% stenosis in the proximal right coronary artery (rca). There was no issues removing the device from the hoop. The device was inspected with no issues. The lesion was pre dilated. The device did not pass through a previously deployed stent. Resistance was encountered. Excessive force was not used. An attempt was then made to deliver a 2. 25 x 38 mm resolute onyx rx coronary, drug eluting stent (pli20) through a proximal 2. 25 x 30 resolute onyx rx coronary, drug eluting stent (pli10) to a distal lesion the stent could not pass the proximal stent. There was no damage noted to the packaging of the 2. 25 x 38mm device (pli20). The 2. 25 x 38mm device was inspected with no issues, negative prep was not performed. It was reported that the 2. 25 x 38 resolute stent (pli 20) deformed inside the 2. 25 x 30 resolute onyx rx stent (pli 10). During removal of the 2. 25 x 38mm deformed stent (pli20) it caught on the 2. 25 x 30mm stent (pli10) and the 2. 25 x 30mm stent (pli10) dislodged. Both stents were snared in the aorta and removed. The lesion was then treated with a 2. 0 x 22 and 2. 25 x 38 resolute onyx rx coronary, drug eluting stent. The patient is alive with no injury.
 
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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 Key9646340
MDR Text Key188470293
Report Number9612164-2020-00478
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
Report Date 04/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/01/2020
Device Model NumberRONYX22530UX
Device Catalogue NumberRONYX22530UX
Device Lot Number0009123119
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/17/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/07/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/02/2018
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: 01/30/2020 Patient Sequence Number: 1
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