AtriClip® PRO•V™ LAA Exclusion System PROV50 (REF A000974)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818354015157), received between Sep 10, 2021 and Sep 10, 2021 — classified as 1 injury.

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

Recent adverse event reports

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

• InjurySep 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT WITH A HISTORY OF PERICARDITIS, AFIB AND HYPERTROPHIC CARDIOMYOPATHY UNDERWENT AN OFF-PUMP LAAM VIA LEFT SIDED MINI THORACOTOMY. THE LEFT LUNG WAS ADHERED TO THE PERICARDIUM AND LUNG ADHESIONS WERE DISSECTED. SURGEON ALSO NOTED LARGE AMOUNT OF PERICARDIAL ADHESIONS. A PROV50 CLIP WAS PLACED ON THE LAA AND TEE WAS PERFORMED AND NOTED THAT THE LAA WAS STILL PATENT. SURGEON OPENED THE DISTAL END OF CLIP BLOOD WAS NOTED. THE CLIP WAS CLOSED BUT BLEEDING WAS STILL EVIDENT, SO THE PHYSICIAN CONVERTED TO A THORACOTOMY. THE PROV50 CLIP WAS REMOVED FROM THE LAA, THE LAA WAS EXCISED AND A PIECE OF BOVINE PERICARDIUM WAS USED TO CLOSE THE LA. AT CLOSE OF PROCEDURE THE PATIENT WAS STABLE, INTUBATED, AND TRANSFERRED TO CVICU FOR RECOVERY. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12453322 ↗