Evolution G46540Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002465401), received between Jun 2, 2016 and Jun 2, 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. How this data works · Data updated Oct 13, 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.

• DeathJun 2, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  INITIALLY AN ICD SYSTEM WAS IMPLANTED IN 1996 FROM THE LEFT. THIS WAS FOLLOWED BY AN ICD EXCHANGE IN 2002 AND 2005. DUE TO A THROMBOTIC SUBCLAVIAN V. LEFT IN 2011 AN ICD SYSTEM WAS IMPLANTED FROM THE RIGHT SIDE. NOW THE RV LEAD SHOULD BE REPLACED DUE TO OVER-SENSING. AFTER USING A LOCKING STYLET AND ENTERING THE VESSEL ANONIMA V. WITH A BYRD 8,5 IT WAS DIFFICULT TO ENTER THE SUPERIOR VENA CAVA. EVEN UP-SIZING TO 10.0, 11.5 AND 13 COULD NOT SOLVE THE PROBLEM AND PUSHING THE BYRD MORE DISTALLY. EVERY TIME THE OUTER-SHEET WAS KINKING. AFTER A SWITCH TO AN EVN 11 DEVICE, THE PASSAGE WAS DONE AND THE EVN GOT STAKED AT THE DISTAL COIL AT THE VENTRICLE. DURING PULLING, SUDDENLY THE PATIENT'S BLOOD PRESSURE DROPPED. PUNCTION OF THE V. FEMORALIS LEFT AND VOLUME COULD HANDLE THE BLOOD PRESSURE AT FIRST. THE PROCEDURE WAS CONTINUED WITH EVN AND THE LEAD CAME OUT. FOLLOWING THIS, THE BLOOD PRESSURE DROPPED AGAIN. THE PATIENT BECAME HYPOTONIC AND THERE WAS A NEED FOR CPR. THE PATIENT ENTERED A HEART-LUNG MACHINE. WITH A PIGTAIL CATHETER THE USER FACILITY SAW A LEAKAGE AT THE UPPER SVC. THE USER FACILITY TRIED TO STOP THE BLEEDING WITH A BALLOON NUKLEOS AND WITH AN AORTIC STENT BUT THE STENT COU

  Patient problems: Death

  MAUDE report 5695469 ↗