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U.S. Department of Health and Human Services

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

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MEDTRONIC VASCULAR RESOLUTE INTEGRITY RX CORONARY DRUG-ELUTING STENT Back to Search Results
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).
 
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Brand NameRESOLUTE INTEGRITY RX
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
MEDTRONIC VASCULAR
MDR Report Key13176830
MDR Text Key283428951
Report NumberMW5106484
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
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 Received01/05/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 01/05/2022 Patient Sequence Number: 1
Treatment
ASPIRIN; ATORVASTATIN; CLOPIDOGREL; DONEPEZIL; METOPROLOL ; PHENYTON; PREDNISONE; SUCCINATE; TICAGRELOR
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