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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
Device Problems Activation, Positioning or SeparationProblem (2906); Detachment of Device or Device Component (2907); Material Deformation (2976)
Patient Problem Insufficient Information (4580)
Event Date 09/10/2020
Event Type  Injury  
Manufacturer Narrative
Journal article: partial stent extraction 14 months after stent implantation as a complication of cutting balloon authors: keisuke shoji, kan zen, kenji yanishi, satoaki matoba journal: cardiovascular intervention and therapeutics year: 2021 reference: doi. Org/10. 1007/s12928-020-00704-z. If information is provided in the future, a supplemental report will be issued.
 
Event Description
An article titled - partial stent extraction 14 months after stent implantation as a complication of cutting balloon was submitted. A 2. 50mm resolute onyx coronary drug-eluting stent (des) was implanted to treat an unprotected subtotal occlusion of the left circumflex artery. Approximately 11 months later a 99% in-stent restenosis (isr) was treated with a drug coated balloon. Approximately 14 months post stent implantation, a symptomatic focal isr recurred and intravascular ultrasound (ivus) demonstrated stent recoil due to severe calcification. A non-medtronic cutting balloon was used to prepare the lesion before implanting a new des. Resistance was felt when removing the cutting balloon after complete deflation. Approximately 7 mm of the proximal stent was inadvertently removed along with the cutting balloon. The patient remained hemodynamically stable, and optical coherence tomography confirmed recoil and avulsion of the neointima. The new des (2. 75x12mm) was deployed at the extraction site. Final angiography and oct confirmed acceptable expansion of the stent. It was suspected that the cutting balloon flex point, which occurs every 5mm along the blade, became afixed to the proximal edge of the under expanded stent and caused the stent extraction.
 
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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 Key12881103
MDR Text Key281314412
Report Number9612164-2021-04594
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeJA
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,Followup
Report Date 01/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/21/2022
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: 11/29/2021 Patient Sequence Number: 1
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