Performa® 00884450283134Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450283134), received between Oct 3, 2019 and Oct 3, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 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.

• MalfunctionOct 3, 2019Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A THORACIC ENDOVASCULAR AORTIC REPAIR [TEVAR] PROCEDURE, THE RADIOPAQUE MARKER ON THE CATHETER DETACHED AND MIGRATED BETWEEN THE ENDOVASCULAR STENT GRAFT AND AORTIC VESSEL WALL. THE PHYSICIAN HAD ACQUIRED ARTERIAL VASCULAR ACCESS AND HAD DELIVERED A GUIDE CATHETER OVER A GUIDE WIRE THROUGH THE DESCENDING AORTA TO THE THORACIC ANEURYSM AND SUCCESSFULLY DEPLOYED TWO AORTIC STENT GRAFTS. DURING CATHETER MANIPULATIONS, THE MARKER BAND DETACHED AND MIGRATED OFF THE GUIDE WIRE AND DRIFTED BETWEEN STENT GRAFT AND AORTIC VESSEL WALL. THE PHYSICIANS ATTEMPT TO RETRIEVE THE RADIOPAQUE MARKER FROM THE PATIENT WERE UNSUCCESSFUL. THE PHYSICIAN THEN BALLOONED THE GRAFT IN POSITION, PINNING THE MARKER BETWEEN THE GRAFT AND THE AORTIC VESSEL WALL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADDITIONAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9151971 ↗