Evolution G23748Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002237483), received between Jun 18, 2021 and Aug 25, 2023 — classified as 1 death, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ATTEMPTED TO DETACH THE ADHESION OF THE ATRIAL LEAD WITH EVNSH9, THE BLOOD PRESSURE DROPPED TO ABOUT 20 WHEN THE TIP OF THE INNER SHEATH WAS ABOUT TO ENTER THE SUBCLAVIAN VEIN AND HAS NOT RISEN SINCE. PROBABLY PERICARDIAL DRAINAGE AND POSSIBLY OPEN THORACOTOMY. ON 23 AUGUST 2023 ADDITIONAL INFORMATION WAS OBTAINED: TARGET SITE WAS RIGHT ATRIUM AND ACCESS SITE WAS LEFT SUBCLAVIAN VEIN. ON 23 AUGUST 2023 ADDITIONAL INFORMATION WAS PROVIDED BY THE PHYSICIAN: THE CAUSE OF CARDIAC TAMPONADE THAT OCCURRED DURING LEAD REMOVAL USING COOK PRODUCTS (EVN AND OFA) WAS THAT THE LEAD TIP, WHICH WAS TINED TO THE INNER WALL OF THE ATRIUM, RUPTURE THE ATRIUM. THE REASON WHY THE LEAD TIP RUPTURED THE ATRIUM WAS THE STRUCTURE OF THE LEAD STRUCTURE (TINED TIP (PASSIVE FIXATION) , NOT THOSE COOK PRODUCTS. THE RUPTURE AREA WAS IMMEDIATELY OPENED AND SUTURED SURGICALLY.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension

  MAUDE report 17622794 ↗
• DeathJun 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEAD EXTRACTION PROCEDURE (B)(6) 2021. SHORTLY AFTER STARTING PROCEDURE, THE USER NOTED MORE BLEEDING THAN USUAL, BUT BELIEVED THIS WAS NOT A MAJOR PROBLEM AT THAT TIME. AFTER BOTH THE RIGHT VENTRICULAR AND RIGHT ATRIUM LEADS WERE REMOVED, A BLOOD TRANSFUSION WAS PERFORMED. IN ATTEMPT TO STOP BLEEDING, A SHEATH (NOT FOR LEAD REMOVAL) WAS INSERTED INTO THE PUNCTURE SITE WITHOUT SUCCESS. THE BLEEDING SITE WAS BELIEVED TO BE SOMEWHERE IN THE SUBCLAVIAN VEIN, NOT THE PUNCTURE SITE; THEREFORE A WIRE GUIDE WAS EMPLOYED FROM THE RIGHT FEMORAL TO THE SUBCLAVIAN VEIN. THE BALLOON WAS THEN INFLATED IN AN EFFORT TO TRY TO STOP THE BLEEDING, BUT FAILED. THE USER CALLED PLASTIC AND VASCULAR SURGEONS WHICH WERE ABLE TO STOP THE BLEEDING. IT WAS ESTIMATED THAT THE DAMAGE TO THE SUBCLAVIAN VEIN WAS LESS THAN 10CM FROM THE PUNCTURE SITE. ADDITIONAL INFORMATION RECEIVED HAS INDICATED THAT THE PATIENT DIED DUE TO SEPSIS.

  Patient problems: Perforation of Vessels

  MAUDE report 12028466 ↗