Evolution G23747Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10827002237473), received between Oct 6, 2016 and Sep 26, 2024 — classified as 5 deaths, 11 injuries.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHILIPS LLD #2 (LEAD LOCKING DEVICE) WAS INSERTED INTO THE STYLET LUMEN OF THE ICD LEAD AND ADVANCED TO THE TIP. 14FR GLIDELIGHT WAS INSERTED THROUGH THE PUNCTURE SITE AND DISSECTION/SEPARATION OF THE ICD LEAD WAS STARTED, BUT IT STOPPED IN THE MIDDLE OF SUBCLAVIAN VEIN. THEREFORE, THE DEVICE WAS CHANGED TO AN EVOLUTION SHORTIE RL 11FR, WHICH ALLOWED IT TO PASS THROUGH THE SUBCLAVIAN VEIN. NEXT, THE DEVICE WAS CHANGED TO AN EVOLUTION RL 11FR, AND WHILE DISSECTING JUST BEFORE THE SVC (SUPERIOR VENA CAVA), THE TIP OF THE LEAD SEEMED TO HAVE COME OFF, BUT IN FACT IT HAD NOT COME OFF, SO THE DEVICE WAS TRIED TO PROCEED WITH DISSECTION AGAIN WITH AN 11FR, BUT THE MIDDLE OF THE SVC COIL (WHERE THERE MAY BE A MASS OF ADHESION TISSUE) DID NOT ENTER THE SHEATH. THEREFORE, THE DEVICE WAS CHANGED TO AN EVOLUTION RL 13FR, BUT THE SAME PART DID NOT ENTER THE SHEATH, SO THE DEVICE WAS CHANGED TO A GLIDELIGHT 16FR, BUT THE SAME PART DID NOT ENTER THE SHEATH. WHEN A 13FR STEADY SHEATH WAS SET INSIDE THE EVOLUTION RL 13FR AND ADVANCED, THE INNER SHEATH OF THE EVOLUTION RL 13FR DID NOT PASS THE MIDDLE OF THE SVC COIL WHERE THERE MAY BE A MASS OF ADHESION TISSUE, BUT THE STEADY SHEATH PASSED THROUG

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 20309089 ↗
• DeathAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER REP - 19AUG2024 - FOUR COOK DEVICES WERE USED IN THE PROCEDURE. THEY FUNCTIONED PROPERLY AND DID NOT CONTRIBUTE TO THE ADVERSE EVENT. THE COOK DEVICES WERE USED AND THEN REMOVED. OTHER NON-COOK DEVICES WERE THEN USED. WHILE ATTEMPTING TO EXTRACT A LEAD WITH A NON-COOK DEVICE, A LEAD IN THE PATIENT BROKE CAUSING A HOLE IN THE PATIENT'S HEART. THE PATIENT HAD TO HAVE THEIR CHEST CRACKED FOR AN OPEN PROCEDURE. THE PATIENT EXPIRED OVER THE WEEKEND AFTER THE OPEN PROCEDURE.

  Patient problems: Cardiac Perforation

  MAUDE report 20040749 ↗
• InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING REMOVAL OF A RIGHT VENTRICLE (RV) LEAD IMPLANTED IN 1995, BLOOD PRESSURE DROPPED AFTER THE TIP OF THE LEAD WAS DETACHED AND REMOVED WITH EVOLUTION 13FR. THE BLOOD PRESSURE, WHICH WAS 85/44 AT THE BEGINNING OF THE PROCEDURE, DROPPED TO 35/24 IN A FEW SECONDS. AFTER REMOVAL OF THE RV LEAD, TRANSESOPHAGEAL ECHOCARDIOGRAPHY WAS PERFORMED TO CHECK FOR CARDIAC TAMPONADE, WHICH SHOWED A DECREASE IN BLOOD PRESSURE ALONG WITH PERICARDIAL EFFUSION. THE PATIENT WAS DIAGNOSED WITH CARDIAC TAMPONADE. CARDIOVASCULAR PHYSICIAN IMMEDIATELY INITIATED CARDIAC MASSAGE, CONNECTED TO PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS), PERFORMED MEDIAN STERNOTOMY, AND REPAIR PROCEDURE WAS PERFORMED. THE PATIENT RETURNED TO INTENSIVE CARE UNIT (ICU).

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 17116649 ↗
• InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEAD LOCKING DEVICES AND LASER SHEATH WERE USED, THEN 13FR EVOLUTION WAS USED. PHYSICIAN NOTICED BLOOD PRESSURE DROPPING.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 17116365 ↗
• DeathJun 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING A LEAD EXTRACTION PROCEDURE TO REMOVE THREE LEADS IMPLANTED WITHIN CHEST (RIGHT ATRIUM, RIGHT VENTRICLE, AND LEFT VENTRICLE) BECAUSE IF A BADLY INFECTED IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD). THE LEAD EXTRACTION PROCEDURE WAS PERFORMED 2 WEEKS AFTER THE INFECTION WAS CONFIRMED. OF THE LEADS TO BE EXTRACTED, THE LEFT VENTRICULAR WAS EXTRACTED FIRST USING A PHILIPS GLIDELIGHT 14FR. AFTERWARDS, THE RIGHT VENTRICULAR LEAD WAS REMOVED USING THE GLIDELIGHT 14FR, GLIDELIGHT 16FR, AND FINISHED WITH THE COOK EVOLUTION RL 13FR WITH A COOK STEADYSHEATH (LR-TSS-13.0). DURING EXTRACTION OF THE RIGHT VENTRICLE LEAD, A STRONG ADHESION AROUND THE SUPERIOR VENA CAVA (SVC) CURVE WAS NOTED. BOTH GLIDELIGHT LASER SHEATHS WERE UNABLE TO GO THROUGH THE SVC, BUT THE EVOLUTION 13FR AND STEADY SHEATH DID PASS THROUGH THE AREA. BLOOD PRESSURE REPORTEDLY DROPPED AS THE EVOLUTION DEVICE ADVANCED BEYOND THE SVC TOWARDS LEAD TIP. IN RESPONSE TO DROP, PERICARDIOCENTESIS WAS PERFORMED AND AN INTRA-AORTIC BALLOON PUMP WAS EMPLOYED WHILE THE PATIENT WAS PLACED ON A PERCUTANEOUS CARDIOPULMONARY SUPPORT SYSTEM. EXTRACTION WAS THEN RESUMED, WITH ALL THE TARGETED L

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 12027209 ↗
• InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TRANSVENOUS LEAD EXTRACTION PROCEDURE WAS PERFORMED, APPROACHING FROM THE SUBCLAVIAN VEIN. THE TARGET LEAD WAS AN ICD LEAD IMPLANTED FOR 12 YEARS. A PHILIPS GLIDELIGHT 14FR SHEATH WAS ADVANCED TO PEEL OFF THE ADHESION, BUT BECAUSE IT STOPPED ADVANCING AT THE SUBCLAVIAN VEIN, THE SHEATH WAS CHANGED WITH PHILIPS GLIDELIGHT 16FR. HOWEVER, THE 16FR GLIDELIGHT SHEATH STOPPED ADVANCING AT THE ELECTRODE COIL OF THE LEAD (PRIOR TO PASSING THROUGH THE ELECTRODE COIL), SO IT WAS EXCHANGED WITH THE COOK EVOLUTION (RL) CONTROLLED-ROTATING DILATOR SHEATH SET (LR-EVN-13.0-RL). THOUGH THE USER FELT ADVANCEMENT DIFFICULTY AT THE ELECTRODE COIL OF THE LEAD AS HE DID WITH THE PHILIPS LASER SHEATH, HE WAS ABLE TO ADVANCE THE EVOLUTION LITTLE BY LITTLE AND REACHED THE TIP OF THE LEAD, THEN THE ICD LEAD COULD BE EXTRACTED WITH COOK¿S LR-OFA01. THE PATIENT¿S BLOOD PRESSURE DECREASED AFTER THAT, BUT BECAUSE IT RECOVERED, THE USER MOVED TO EXTRACTION OF ATRIAL LEAD. THE ATRIAL LEAD COULD BE EXTRACTED WITH PHILIPS¿ LASER SHEATH 14FR AND LOCKING DEVICE (LLD-EZ) EASILY. THOUGH THE BLOOD PRESSURE WAS NOT STABLE, A SHEATH WAS INSERTED IN ORDER TO PLACE A NEW LEAD. THE PHYSICIAN CHECKED T

  Patient problems: Great Vessel Perforation; Low Blood Pressure/ Hypotension; Paraplegia

  MAUDE report 10929066 ↗
• DeathSep 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING A LEAD EXTRACTION PROCEDURE FOR A BROKEN ELECTRODE (BIOTRONIC) THAT HAD BEEN IMPLANTED IN THE PATIENT FOR 8 YEARS WITH HEAVY ADHESION. A COOK CONTROLLED-ROTATION DILATOR SHEATH SET (LR-EVN-13.0-RL) WAS USED BY AN EXPERIENCED TEAM OF CARDIAC SURGEONS AND WITH AN INTERVENTIONAL CARDIOLOGIST PRESENT. WHILE USING THE COOK DEVICE, WHICH THEY HAD TO REMOVE TO CLEAN/ FLUSH, THE PATIENT¿S BLOOD PRESSURE BEGAN TO DROP. THE PATIENT WAS GIVEN MEDICATION, THEN THE TEAM INJECTED A CONTRAST TWICE INTO THE PATIENT TO SEE IF THERE WAS A VESSEL TEAR OR PERFORATION, HOWEVER THEY SAW NO PROBLEM. THEREFORE THEY CONTINUED WITH USE OF THE DEVICE AND 1 MINUTE LATER THE ANESTHESIOLOGIST REPORTED A PROBLEM. A THORACOTOMY WAS PERFORMED BUT NO BLOOD LEAKAGE WAS FOUND. AFTER OPENED MORE ABOVE, THEY SAW THAT THE EVOLUTION WAS WORKING AS A BLOCK FOR A TEAR IN HE SUPERIOR VENA CAVA, SO THERE WAS NO BLEEDING UNTIL THAT POINT. THEY TRIED TO REPAIR THE TEAR AT THE SUPERIOR VENA CAVA BUT THE BLOOD LOSS WAS SO MUCH THAT THEY COULDN¿T SAVE THE PATIENT. THE PHYSICIAN DOESN¿T THINK IT WAS DEVICE RELATED DEATH BUT THE VESSEL WALL WAS VERY FRAGILE AND THE ADHESION WAS TOO MU

  Patient problems: Death; Great Vessel Perforation; Low Blood Pressure/ Hypotension

  MAUDE report 10546678 ↗
• InjuryMay 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO CUSTOMER RELATIONS VIA COMPLAIN FORM "WHEN THE RIGHT ATRIAL LEAD WAS EXTRACTED, THE PATIENT "LOST HIS BLOOD PRESSURE AND WAS FOUND TO BE IN TAMPONADE." STERNOTOMY WAS PERFORMED TO DRAIN BLOOD FROM THE PERICARDIUM. THE HOLE IN THE ATRIAL APPENDAGE HAD ALREADY SEALED BY THE TIME IT WAS REACHED BY THE SURGEON.

  Patient problems: Cardiac Tamponade

  MAUDE report 10051426 ↗
• InjuryMar 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO NEW INFORMATION HAS BEEN REPORTED REGARDING THIS EVENT.

  Patient problems: Great Vessel Perforation

  MAUDE report 9842062 ↗
• DeathJul 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LEAD EXTRACTION PROCEDURE UTILIZING THE COOK EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET (LR-EVN-13.0-RL) THE VENTRICULAR PACEMAKER LEAD WAS REMOVED, AND THE PATIENT BEGAN TO EXPERIENCE ACUTE HYPOTENSION AND CARDIAC ARREST DUE TO A POSSIBLE LACERATION OF THE HEART. PERICARDIOCENTESIS AND RESUSCITATION MANEUVERS WHERE PERFORMED FOR 30 MINUTES WITHOUT SUCCESS AND PATIENT EXPIRED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ADDITIONAL PATIENT AND EVENT DETAILS HAVE BEEN REQUESTED. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN FORTHCOMING.

  Patient problems: Cardiac Perforation; Death; Low Blood Pressure/ Hypotension

  MAUDE report 8785767 ↗
• DeathOct 15, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  INITIAL RR 76/48, 9:40 START, 9:50 DEVICE EXPLANT 10:15 RV1 LLD EZ, 10:18 RV2 LLD EZ, 10:20 RV2 GLIDELIGHT 14 EASY WORK TO ATRIUM THEN NO PROGRESSION, 10:25 RV1 GLIDELIGHT 14 EASY WORK TO HIGH SVC THEN NO PROGRESSION, 10:30 RV1 EVN 13 RL N155274 EASY WORK TO APEX THEN 1 CM BEFORE TIP NO PROGRESSION, 10:33 VF 2X 360 J DEFIB NO PRESSURE REANIMATION =>ADRENALIN RR 103/48, 10:38 RV2 EVN 13 RL EASY WORK TO APEX, 10:40 RV2 EXTRACTED IN TOTO, 10:41 CURRENT BLACKOUT OF ANESTHESIA MONITORS => TEE MACHINE RESTARTED, 10:45 RR 42/3, 10:54 HLM STARTED TO STABILIZING PATIENT, 11:00 REANIMATION, 11:12 ECHO PLEURA EFFUSION => THORACOTOMIES, 11:15 HLM RUNNING, 11:20 4 CM HIGH SVC SUPERIOR CUT CLOSED WITH PATCH, 11:30 3 CM CUT AT V. ANONIMA CLOSED WITH PATCH, 11:27 PATIENT STABILIZED, 12:28 LOW FLOW VIA SVC DUE TO SURGICAL LUMEN REDUCTION WITH PATCH, 12:45 VOLUMEN REFILLING WITH CELLSAVER AND ECMO. ONLY 0,6 - 1,2 L VOLUME FILLING POSSIBLE, DUE TO CLOSED SVC. REFILLING WITH T ADAPTER AND VIA V. PULMONALE, V. FEMORAL AND SVC WITHOUT BIGGER SUCCESS, 13:30 DECISION TO STOP THE PUMP => EXITUS.

  Patient problems: Death

  MAUDE report 7966496 ↗
• InjuryJan 8, 2018Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE COURSE OF THE LEAD EXTRACTION PROCEDURE, A SMALL BLEED OCCURRED IN A MINOR BRANCH OF THE INNOMINATE VEIN. INTERVENTION WAS REQUIRED IN THE FORM OF A CHEST DRAIN AND BOTH LEADS WERE EXTRACTED SUCCESSFULLY. ACCORDING TO THE INITIAL REPORTER, AFTER PUTTING THE DRAIN IN AND CONTINUING WITH THE LEAD EXTRACTION, "PATIENT IS FINE." THE LEADS HAD BEEN IMPLANTED FOR OVER 17 YEARS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Perforation of Vessels

  MAUDE report 7171523 ↗
• InjuryNov 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT, WHILE THE LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET WAS IN USE OVER A 1085-64 BSCI ICD LEAD WITH SPECTRANETICS LLD-EZ LOCKING STYLET IN PLACE TO RELEASE FIBROTIC BINDING SITES ALONG THE LEAD, AN EFFUSION WAS DETECTED ON THE TRANSESOPHAGEAL ECHOCARDIOGRAM. THIS EFFUSION WAS DETECTED SHORTLY AFTER THE EVOLUTION RL REACHED AN AREA IN THE RIGHT ATRIUM. CARDIOTHORACIC SURGERY AND HEART PUMP TEAM WERE CALLED IMMEDIATELY. THE HEART TEAM OPENED THE PATIENT'S CHEST TO EXPOSE THE HEART, AND THE TEAR IN THE ATRIUM WAS REPAIRED. THE PATIENT LATER RETURNED AND THE LEADS WERE SUCCESSFULLY SNARED. THE PATIENT IS REPORTEDLY DOING FINE. THE PRODUCT IS UNAVAILABLE FOR RETURN AND EVALUATION.

  Patient problems: Atrial Perforation

  MAUDE report 7067039 ↗
• InjuryJul 31, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE PHYSICIAN WAS PERFORMING AN INTRACARDIAC DEFIBRILLATOR EXTRACTION FOR INFECTION ON A PATIENT. THE PHYSICIAN USED LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET DURING THE PROCEDURE. SOON AFTER THE BLOOD PRESSURE DROPPED, THE PHYSICIAN FOUND A TEAR IN SUPERIOR VENA CAVA INNOMINATE VEIN. THE PHYSICIAN PLACED A BALLOON FROM A DIFFERENT MANUFACTURER TO CONTROL BLEEDING AND A SURGEON WAS CALLED IN. THE SURGEON PERFORMED AN OPEN CHEST SURGICAL REPAIR. AFTER THE CHEST WAS OPENED, AN AORTIC TEAR WAS NOTED. THE TEAR WAS DUE TO THE EXCESSIVE MANIPULATION NEEDED AS THE PATIENT HAD SEVERE SCARRED ANATOMY. THE PATIENT WAS IN STABLE CONDITION POST-SURGERY. NO UNINTENDED SECTIONS OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY. ADDITIONAL INFORMATION IS REQUESTED FROM THE CUSTOMER.

  Patient problems: Hemostasis; Laceration(s); Low Blood Pressure/ Hypotension

  MAUDE report 6753832 ↗
• InjuryMar 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE USER FACILITY THAT A PATIENT UNDERWENT A LEAD EXTRACTION PROCEDURE USING A LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET. THE ATTENDING PHYSICIAN INDICATED THAT THE LOCKING STYLET AND ONE TIE WAS PLACE IN THE PATIENT WHILE ATTEMPTING TO EXTRACT WITH THE LR-EVN-13.0-RL. ONCE TRACTION WAS APPLIED TO THE LEAD AND LOCKING STYLET, THE LEAD PULLED AWAY FROM THE RIGHT VENTRICLE AND PERFORATED THE VENTRICLE. THE LR-EVN-13.0-RL WAS NOT ANYWHERE NEAR THE TIP OF THE LEAD. THE LEAD SCREW THAT WAS AT THE TIP OF THE LEAD DID NOT RETRACT, THEREFORE IT WAS STILL SCARED IN AND ADHERED TO THE HEART WALL; WHEN TRACTION WAS APPLIED, PERFORATION OCCURRED. AN OPEN CHEST PROCEDURE WAS PERFORMED TO REPAIR THE PERFORATION. PATIENT IS IN STABLE CONDITION. THE PHYSICIAN FEELS THIS INCIDENT WAS NOT PRODUCT RELATED. THERE WERE NO UNINTENDED SECTIONS OF THE DEVICE THAT REMAINED INSIDE OF THE PATIENT¿S BODY, NOR DID THE PATIENT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Perforation

  MAUDE report 6371401 ↗
• InjuryOct 6, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT A LEAD EXTRACTION FROM A SUPERIOR APPROACH, FROM THE SUBCLAVIAN VEIN DOWN TO THE RIGHT VENTRICLE PROCEDURE. DURING THE PROCEDURE THE PHYSICIAN NOTICED THAT THE PATIENT'S BLOOD PRESSURE WAS DECREASING. AFTER TRYING TO STABILIZING THE PATIENT WITHOUT POSITIVE RESULTS THE PHYSICIAN DECIDED TO OPEN THE CHEST VIA A STERNOTOMY TO IMMEDIATELY CONTROL THE RA AND THE IVC. A SMALL TEAR WAS DETECTED AT THE IVC. HOWEVER, IT WAS PATCHED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available; Rupture

  MAUDE report 6002714 ↗