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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 RONYX35038X
Device Problems Fracture; Device Dislodged or Dislocated; Material Deformation
Event Date 09/16/2019
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

During a procedure it was intended to use a 2. 50 x 38 mm resolute onyx stent to treat a non tortuous, non calcified lesion exhibiting 100% stenosis located in the mid right coronary artery (rca). The device was inspected with no issues. Negative prep was performed without issue. The lesion was crossed with a non-medtronic guide wire and pre-dilated using a 2. 0 x 30 mm balloon at 12 atm for 20 seconds. 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. The stent was deployed at 14 atm for 20 seconds and then post-dilated using a 3. 75 x 15 mm balloon at 12 atm for 20 seconds. It was reported that after implantation stent strut deformation in the mid segment was observed, indicating a stent fracture. Therefore a 3. 50 x 18 mm resolute onyx stent was deployed at 12atm for 20 seconds and post dilated using a 3. 75 x 15 mm balloon at 12 atm for 20 seconds. Timi 3 flow was achieved with no residual stenosis in the treated lesion. The patient was reported to be alive with no injury.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

It was reported that stent fracture was observed by angiography. If information is provided in the future, a supplemental report will be issued.

 
Manufacturer Narrative

Image analysis summary: an image shows a stent being delivered to the rca. An image shows the stent being deployed. An image shows post dilation being performed. An image shows narrowing at the mid-section of the stent, suggesting further post dilation required. An image shows a contrast shot narrowing at the mid-section of the stent is visible. An image shows a non-contrast image, there is a region of the stent where the struts are not visible. Stent fracture cannot be confirmed from this image, possible stent struts separation. A contrast image shows possible separation of stent struts. A contrast image shows possible separation of stent struts. An image shows a non-contrast image, there is a region of the stent where the struts are not visible. A magnified image shows the region of the stent where fracture was reported, however this cannot be confirmed. A magnified image shows the region of the stent where fracture was reported, however this cannot be confirmed. An image shows a second stent being delivered inside the first stent. An image shows the second stent being deployed. A contrast image of the stent post deployment shows that the possible stent separation has been resolved. If information is provided in the future, a supplemental report will be issued.

 
Manufacturer Narrative

Image analysis summary: procedural images confirm the events as reported from the account regarding the vessel morphology exhibiting 100% stenosis and the lesion being tortuous and calcified. The 100% stenosis or cto was at the proximal to mid vessel. The cto was resolved when the procedural guide wire was loaded into the vessel. The sever calcification in the mid vessel was then evident from the images. The point of suspected stent fracture is at the level of the tightest stenosis and calcification in the vessel in addition to being a junction of the ostium of the side branch. All these factors contributed to the previously adjacent stent wraps of the stent being pushed out of alignment due to the difficult morphology, resulting in what was reported as a stent fracture. There is no evidence of stent material or weld breakage. This artefact appears more to be stent deformation in vivo post deployment due to the vessel morphology. 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 Key9108461
Report Number9612164-2019-04043
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 12/16/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/24/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberRONYX35038X
Device LOT Number0009549304
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 Received12/13/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/23/2019
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: 09/24/2019 Patient Sequence Number: 1
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