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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 Separation Problem (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.
 
Manufacturer Narrative
Additional information: annex d code added procedural images in the article confirm the reported in-stent restenosis and show the extracted stent medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
RESOLUTE ONYX RX
Type of Device
CORONARY 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 Physician
Type of Report Initial,Followup
Report Date 01/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/15/2021
Initial Date FDA Received11/29/2021
Supplement Dates Manufacturer Received01/21/2022
Supplement Dates FDA Received01/27/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age86 YR
Patient SexFemale
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