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

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

Patient Problems Angina (1710); Local Reaction (2035); Stenosis (2263); Insufficient Information (4580)

Event Date 12/21/2022

Event Type  Injury  

Manufacturer Narrative

Title: kounis syndrome and vanadium allergy: heed your hunch year: 2023 reference: doi: 10.18176/jiaci.0884 a2: average age a3: majority gender b3: date of publication 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 journal article was submitted for review titled; kounis syndrome and vanadium allergy: heed your hunch.This article describes the case of a patient with kounis syndrome associated with allergy to vanadium.The patient had a previous history of several revascularization procedures from 2016 to may 2021.The patient had undergone four percutaneous coronary intervention (pci) procedures at a different facility, three with unknown stent brand and one with a non-medtronic drug eluting stent (des).Three further revascularization procedures were performed at this hospital since june 2019, two with medtronic resolute onyx stents and one with a non-medtronic stent, giving a total of seven stents implanted.On this admission the patient was admitted with unstable angina.Angiography showed persistence of adequate results for the previous pci in the left circumflex (lcx) and right coronary artery (rca), and severe in-stent restenosis of the left anterior descending (lad) artery.Optical coherence tomography (oct) revealed important neointimal findings.The patient then underwent coronary artery bypass surgery.Six months after surgery, further catheterization for recurrent severe angina revealed in-stent restenosis of the lcx artery, and a second surgical revascularization procedure was performed.Given the multiple cardiovascular events and the unusual oct findings, the patient was referred to the allergology department.Patch tests were performed with the baseline series, with an expanded metal battery.Tests were read at 48 and 96 hours.They were all negative except for a positive reaction to vanadium (iii) chloride 1% pet at 48 and 96 hours, and for a doubtful reaction with faint erythema only in the case of the resolute onyx stent.Patch testing with vanadium (iii) chloride 1% in 5 asymptomatic controls with the onyx stent elicited no reaction.A semiquantitative analysis of an onyx sample surface was performed using scanning microscopy and energy dispersive spectrometry at 20°c and 20 kv.Chemical composition analysis was carried out on the missing areas of organic film around the sample filaments.The presence of the metals described in the data sheet was confirmed showing a vanadium content of 0.1%.No other elements were detected.A lymphocyte transformation test (ltt) to detect t-cell proliferation against the metals present in the stent was then performed.A stimulation index = 3 was considered a positive response.The patient had a positive reading at all concentrations of vanadium (iii) chloride, and a negative reading with the remaining allergens.Ltt in 5 controls with the onyx stent showed no response to any component.The symptoms and initial findings (positive patch test result for vanadium, which is theoretically not present in the stent) made it necessary to use all possible means to confirm the presence of this metal and its clinical relevance.Since vanadium is frequently used in alloys with other metals, we cannot rule out the possibility that it may also be present in other stent alloys.

Manufacturer Narrative

Additional information: annex d code.Correction: a2: average age a3: majority gender age and gender are patient specific.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: STENT, CORONARY, DRUG-ELUTING
• 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: 18373004
• MDR Text Key: 331108287
• Report Number: 9612164-2023-06144
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• 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?: No
• Date Manufacturer Received: 02/02/2024
• 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): Other; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male