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

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

Patient Problems Aneurysm (1708); Myocardial Infarction (1969); Rash (2033); Local Reaction (2035); Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Date 10/09/2015

Event Type  Death  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A patient presented with a non-st elevated myocardial infarction (nstemi) and was treated for right coronary artery stenosis with at herectomy and four resolute integrity drug eluting stents, aspirin and clopidogrel.43 days later the patient sustained recurrent nstemi.Angiography showed in-stent thrombosis in a newly aneurysmal area which was treated with manual thrombectomy and balloon angioplasty.The patient was discharged on aspirin and ticagrelor.74 days after initial stenting the patient presented with a diffuse macular pruritic rash accompanied by eosinophilia.This rash had been present for several weeks before, and over the counter topical treatments at home had failed.The patient's only known allergy was penicillin which caused 'swelling'.No changes had been made to the patient's long standing medication.To determine if the new antiplatelet medication, aspirin and ticagrelor, were the cause of the rash, sequential elimination of both was carried out for 6 weeks at a time.However, the rash persisted both times making an allergy to the antiplatelet medication unlikely.Allergy to zotarolimus was considered unlikely since the reaction did not subside after 180 days, which is the length of time zotarolimus is measurable after stent deployment.Daily oral prednisolone diminished the rash but tapering of the steroid worsened it.A skin test was done 454 days after initial stenting which revealed sensitivity to nickel, manganese, titanium, vanadium and zinc.The patient was not a candidate for surgical explant.Eosinophilia persisted long-term and the patient stayed on steroids for approximately 3 years until the patient died.

Manufacturer Narrative

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 INTEGRITY 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: 13411498
• MDR Text Key: 284788126
• Report Number: 9612164-2022-00419
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• 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?: No
• Date Manufacturer Received: 03/21/2022
• 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; Death; Other
• Patient Sex: Male