Open Pivot™ 505DA16 (UDI 00613994868848)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994868848), received between Apr 20, 2017 and Apr 20, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Gradient Increase” (1 report).

2 other recalls cover devices cleared under the same FDA submission (P990046); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

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

• InjuryApr 20, 2017Gradient Increase; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 11 MONTHS FOLLOWING THE IMPLANT OF THIS MECHANICAL AORTIC VALVE, THE DEVICE WAS EXPLANTED AND REPLACED BY ANOTHER MECHANICAL VALVE DUE TO AORTIC STENOSIS RESULTING FROM PANNUS FORMATION BENEATH THE VALVE, AND ELEVATED GRADIENTS, WITH A MEAN GRADIENT OF 50 MMHG AND A PEAK GRADIENT OF 90 MMHG. NO OTHER ADVERSE PATIENT EFFECTS ATTRIBUTED TO THIS VALVE WERE REPORTED. MEDTRONIC RECEIVED INFORMATION THAT TWO DAYS FOLLOWING THE IMPLANT OF THIS MECHANICAL AORTIC VALVE (PLI 20), THIS PATIENT EXPIRED. THE PHYSICIAN NOTED IN THE OPERATIVE NOTES THAT THE PATIENT HAD A VERY DIFFICULT ANATOMY TO OPERATE ON. NEAR THE END OF THE VALVE REPLACEMENT PROCEDURE, THE PHYSICIAN NOTED THERE WAS "A CLOT FORMATION AT THE END OF [THE PATIENT'S] ENDOTRACHEAL TUBE WHICH MADE IT IMPOSSIBLE TO VENTILATE HER. THIS LED TO A SERIES OF VERY, VERY DIFFICULT MOMENTS WHERE, BECAUSE THE TUBE WAS SO SMALL IT WAS DIFFICULT TO EVACUATE ANYTHING OUT OF IT. . ." THE ENDOTRACHEAL TUBE WAS EVENTUALLY CLEARED AND VENTILATION RESUMED, "BUT NOT BEFORE [THE PATIENT] EXPERIENCED SOME HORRIFIC BLOOD GASES AND HYPO VENTILATION AND HYPOTENSION." THE PATIENT WAS MOVED TO THE INTENSIVE CAR

  Patient problems: Aortic Valve Stenosis; Corneal Pannus

  MAUDE report 6508616 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P990046. One submission often covers many models, so check the product and lot details in each record.

• Z-1533-2020 · Feb 11, 2020 · Terminated
  Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
• Z-0634-04 · Feb 18, 2004 · Terminated
  ATS Open Pivot Mechanical Heart Valve