Convey 5FConvey RBR3Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729798545), received between Oct 3, 2016 and Oct 3, 2016 — 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 16, 2026.

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathOct 3, 2016

  IT WAS REPORTED THAT THE PATIENT DIED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) AND PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY (LAD). A 5F CONVEY GUIDE CATHETER RBR3 WAS PLACED AND A 2.25X15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR PRE DILATATION OF THE LESION. THEN A 2.50 MM SYNERGY STENT WAS IMPLANTED IN THE RCA WITHOUT COMPLICATIONS. POST DILATATION WAS PERFORMED USING A 15 MM X 2.50 MM NC QUANTUM APEX BALLOON CATHETER. THE RECENTLY IMPLANTED STENT WAS PATENT WITH NO DISSECTIONS NOTED. A FRACTIONAL FLOW RESERVE (FFR) ASSESSMENT WAS THEN PERFORMED IN THE PROXIMAL TO MID LAD AND THE LESION WAS PRE DILATED USING A BALLOON CATHETER. AN ATTEMPT WAS MADE TO DEPLOY A 2.50 MM X 32 MM SYNERGY STENT, HOWEVER, THE PATIENT BECAME RESTLESS AND WAS NOTED TO HAVE ELECTROCARDIOGRAM (ECG) CHANGES IN THE INFERIOR LEAD. THE 2.50 MM X 32 MM SYNERGY STENT WAS ABLE TO BE DEPLOYED IN THE LAD AND ALL ACCESS TO THE LAD WAS REMOVED. ANGIOGRAPHY OF THE RCA WAS PERFORMED AND REVEALED THAT THE RCA WAS BLOCKED. A GUIDE WIRE WAS THEN PLACED IN THE RCA AND DILATATION WAS PERFORMED USING A 2.0 MM BALLOON CATHETER TO OPEN THE VESSEL. ANOTHER FLUOROSCOPY WAS TAKEN AND REVEA

  MAUDE report 5993497 ↗