Resolute Integrity™ RSINT27530UXRecalls & reported problems
Medtronic, Inc. · Stent RSINT27530UX MicroTrac 2.75X30RX · Class 3 · Implant
All models of Resolute Integrity (52)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169037472), received between Nov 22, 2017 and Nov 22, 2017 — classified as 1 death.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Death1
- Myocardial Infarction1
- Thrombus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathNov 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PHYSICIAN IMPLANTED 3 RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENTS IN THE PROXIMAL, MID LAD WHICH HAD SEVERE TORTUOSITY AND CALCIFICATION WITH 100% STENOSIS (CTO). THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO THE LESION. NO DAMAGE WAS NOTED TO THE PACKAGING AND NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS NOT INSPECTED AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS USED DURING DELIVERY. A RESOLUTE INTEGRITY DES (3.0X15) WAS IMPLANTED IN THE MID LAD AND POST-DILATED WITH A NC EUPHORA (3.25X8). ANOTHER RESOLUTE INTEGRITY DES (3.0X15) WAS IMPLANTED IN THE PROX LAD AND POST-DILATED WITH THE SAME NC EUPHORA BALLOON. A RESOLUTE INTEGRITY DES (2.75X30) WAS IMPLANTED IN THE MID RCA AND WAS POST-DILATED BY THE SAME NC EUPHORA BALLOON. IT WAS REPORTED THAT 7 DAYS POST MDT STENT IMPLANTATION, THE PATIENT CAME INTO THE ER WITH A STEMI AND VT (VENTRICULAR TACHYCARDIA). THE PATIENT RECEIVED DEFIBRILLATION TWICE, A CVL (CENTRAL VENOUS LINE), CPR WITH BALLOON PUMP AND LHC (LEFT HEART C
Patient problems: Death; Myocardial Infarction; Thrombus
MAUDE report 7052409 ↗
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- SYNERGY™ H7493926016250Boston Scientific Corporation · Coronary drug-eluting stent6 deaths82 reports
- XIENCE Sierra™ 1550350-33Abbott Vascular Inc. · Coronary drug-eluting stent1 recall32 reports
- Resolute Onyx™ RONYX30022UXMedtronic, Inc. · Coronary drug-eluting stent6 deaths76 reports
- SYNERGY™ H7493926024300Boston Scientific Corporation · Coronary drug-eluting stent3 deaths75 reports
- Resolute Onyx™ RONYX30015UXMedtronic, Inc. · Coronary drug-eluting stent3 deaths73 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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