MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE ONYX RX; CORONARY DRUG-ELUTING STENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Myocardial Infarction (1969); Local Reaction (2035); Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Date 12/07/2021

Event Type  Injury  

Manufacturer Narrative

Journal article: durable polymer drug eluting stent-induced kounis syndrome and eosinophilia requiring long-term immunosuppression authors: thomas boucher, aman m.Shah, hayder hashim, elina jerschow, anna e.Bortnick journal: canadian journal of cardiology year: 2022 reference: doi.Org/10.1016/j.Cjca.2021.12.001.Date of event: date of publication patient death was also included in the results of the journal article, however no causal link suggesting that the medtronic devices used in the patient may have caused or contributed to the deaths was provided.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.

Event Description

A case study was submitted for review titled: durable polymer drug eluting stent-induced kounis syndrome and eosinophilia requiring long-term immunosuppression.The patient presented with non st elevation myocardial infarction (mi) and was treated for right coronary artery stenosis with atherectomy and 4 resolute onyx drug eluting stents and was put on aspirin and clopidogrel.Approximately 43 days post this procedure, the patient had recurrent non st elevation mi.Angiography showed in-stent thrombosis in a newly aneurysmal area, which was treated with manual thrombectomy and balloon angioplasty.The patient was discharged with a prescription for aspirin and ticagrelor.Approximately 74 days after the initial procedure the patient presented with a diffuse macular pruritic rash accompanied by eosinophilia.The patient¿s only known allergy was ¿swelling¿ to penicillin and there were no changes to the patient's longstanding medications.There was sequential elimination of each medication for more than 6 weeks to determine if this was a reaction to the antiplatelet medication.The rash persisted after more than 6 weeks, which shifted attention to the stent.Zotarolimus is 85% eluted after 60 days and is measurable in circulation for up to 180 days.Allergy to zotarolimus was considered unlikely because the reaction did not subside after 180 days.Daily oral prednisone (30 mg) diminished the rash, but tapering worsened it.Skin testing 454 days after stenting revealed sensitivity to nickel, manganese, titanium, vanadium, and zinc.The patient was not a candidate for surgical explant.Eosinophilia persisted in the long term.The patient continued taking steroids for approximately 3 years until the patient's death.

Manufacturer Narrative

Additional information: procedural images/data in the article provided the basis of the analysis.The images confirm the presence of in in-stent thrombosis in a newly aneurysmal area 43 days after initial stenting.The images also confirm the presence of a skin rash on the patient.Annex d code added.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.

• 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14775190
• MDR Text Key: 294543294
• Report Number: 9612164-2022-02367
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 85 YR
• Patient Sex: Male