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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Myocardial Infarction (1969); Rash (2033); Thrombosis/Thrombus (4440)

Event Date 10/09/2015

Event Type  Death  

Event Description

An (b)(6) man presented with non-st elevation myocardial infarction (nstemi) and was treated for right coronary artery stenoses with atherectomy and 4 resolute dp-des, aspirin and clopidogrel (medtronic, (b)(4)).He sustained recurrent nstemi 43 days later.Angiography demonstrated in-stent thrombosis in a newly aneurysmal area which was treated with manual thrombectomy and balloon angioplasty.He was discharged on aspirin and ticagrelor.He presented with a diffuse macular pruritic rash accompanied by eosinophilia (2500/?l, reference: 100-300/?l) 74 days after initial stenting, though it had been present for several weeks before and he had failed topical over the counter treatments at home.The patient's only known allergy was "swelling" to penicillin; there were no changes to his longstanding medications, phenytoin, donepezil, metoprolol succinate and atorvastatin.Sequential elimination, each for >6 weeks, was used to determine if he was reacting to antiplatelets.First, clopidogrel was resumed in place of ticagrelor, but the rash persisted >6 weeks making an allergy to ticagrelor unlikely.Second, aspirin was eliminated for >6 weeks.The rash persisted; therefore, aspirin was restarted and clopidogrel was eliminated.The rash persisted after >6 weeks, shifting attention to the stent.Zotarolimus is 85% eluted after 60 days and is measurable in circulation for up to 180 days.One allergy to zotarolimus was considered unlikely since the reaction did not subside after 180 days.Daily oral prednisone (30 mg) diminished the rash, tapering worsened it.Skin testing 454 days after stenting revealed sensitivity to nickel, manganese, titanium, vanadium, and zinc.He was not a candidate for surgical explant, eosinophilia persisted long-term, and he stayed on steroids for approximately 3 years until his death.Fda safety report id # (b)(4).

• Brand Name: RESOLUTE INTEGRITY RX
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC VASCULAR
• MDR Report Key: 13176830
• MDR Text Key: 283428951
• Report Number: MW5106484
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/04/2022
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASPIRIN; ATORVASTATIN; CLOPIDOGREL; DONEPEZIL; METOPROLOL ; PHENYTON; PREDNISONE; SUCCINATE; TICAGRELOR
• Patient Outcome(s): Other; Death
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White