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 10840143900242), received between May 5, 2022 and May 5, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Positioning Failure” (1 report).

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.

• InjuryMay 5, 2022Positioning Failure; Positioning Failure

  ON (B)(6) 2022, A PATIENT UNDERWENT AN OFF-PUMP, LEFT ATRIAL APPENDAGE MANAGEMENT (LAAM) SURGICAL PROCEDURE. THE PHYSICIAN PLACED A PROV50 CLIP, BUT THE CLIP WAS NOT DEPLOYED AT BASE OF LAA PER TEE MULTIANGLE VIEW. THE PHYSICIAN READJUSTED THE CLIP POSITION AND BLEEDING WAS OBSERVED NEAR THE LAA. THE CAUSE OF THE BLEED WAS UNDETERMINED AND THE PHYSICIAN NOTED THAT THE PATIENT HAD FRIABLE TISSUE. THE BLEEDING DID NOT STOP POST CLIP DEPLOYMENT, SO THE PHYSICIAN PERFORMED A STERNOTOMY. SURGEON PLACED A SECOND PROV50 ON THE BASE OF THE LAA UNDER DIRECT VISUALIZATION TO CONTROL BLEEDING. THE BLEEDING SLOWED BUT DID NOT STOP, SO PATIENT WAS PUT ONTO CPB TO GET HEMOSTASIS. THE BLEED WAS REPAIRED AND HEMOSTASIS WAS ACHIEVED. THE PATIENT WAS STABLE POST-PROCEDURE. THIS WAS A PROCEDURAL COMPLICATION WITH NO REPORTED DEVICE MALFUNCTIONS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14292447 ↗