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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
Catalog Number RONYX35038X
Device Problems Migration or Expulsion of Device (1395); Material Deformation (2976)
Patient Problem Insufficient Information (4580)
Event Date 12/04/2020
Event Type  Injury  
Manufacturer Narrative
Title: percutaneous coronary intervention in coronary artery aneurysms; technical aspects. Report of case series and literature review year: 2020 reference: doi. Org/10. 1016/j. Carrev. 2020. 12. Date of event: date of publication. If information is provided in the future, a supplemental report will be issued.
 
Event Description
A journal article titled; percutaneous coronary intervention in coronary artery aneurysms; technical aspects. Report of case series and literature review was submitted for review. This case reports that a patient presented with an inferior stemi. Coronary angiography via right radial access route showed an acute occlusion in the rca. The coronary artery aneurysms (caa) became apparent only following wiring the vessel. Covered stent with an appropriate size was not immediately available in the catheterisation laboratory, therefore pci was attempted with a 2. 5 × 12 mm semicompliant balloon and a 3. 5 × 34 mm resolute onyx drug eluting stent (des). The second aneurysm became apparent after stent deployment. It was this second aneurysm which was occluded. A 3. 5 × 38 mm resolute onyx stent was deployed overlapping the first stent. It was then decided to line the stents with a covered stent. Upon trying to advance the covered stent, the guide catheter and the wire position were lost. The guide catheter was switched from jr4 to ar1 and the vessel was rewired. When advancing the guide liner extension catheter the proximal stent was displaced forward inside the large aneurysm and buckled. Thereafter it was not possible to advance a balloon or other devices through the angled stent. Given the low likelihood of success and potentially life-threatening complications, the procedure was abandoned, and medical therapy was suggested. The patient remained stable and was discharged home a few days later with combination of medications. The patient was followed up in the outpatient clinic after two months' time and reported no cardiovascular symptoms.
 
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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
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key13051112
MDR Text Key282551282
Report Number9612164-2021-04943
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P160043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature
Reporter Occupation
Type of Report Initial
Report Date 12/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRONYX35038X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/15/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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: 12/21/2021 Patient Sequence Number: 1
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