Evolution G23746Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10827002237466), received between Jun 4, 2015 and Jul 31, 2026 — classified as 5 deaths, 17 injuries.

The most frequently reported specific device problem is “Break” (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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  The following information was received from Merit Medical on behalf of the user facility: Extraction procedure of an A-lead ((b)(6)) that had been in place for approximately 10 years. When the Evolution (EVO11) was advanced to the J-curve of the lead, the tip of the lead became detached. Subsequently, the patient developed hypotension, and an open thoracotomy was performed. A laceration was found around the Right Atrium Superior Vena Cava (RA-SVC) junction. After the thoracotomy, the chest was closed, and the patient was transferred out of the operating room.

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

  MAUDE report 50098689 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PROCEDURE WAS STARTED AFTER GRASPING THE LEAD FROM THE FEMORAL ARTERY PER RIGHT ATRIUM (RA) WITH A NEEDLE EYE'S SNARE (NES). THE REASON FOR TRACTION FROM BELOW WAS TO MAKE THE SHEATH AND LEAD COAXIAL AND EASY TO DETACH APPROACHING FROM THE UPPER EXTREMITY, AND TO REDUCE THE RISK OF SUPERIOR VENA CAVA (SVC) INJURY. FROM THE UPPER EXTREMITY, WE USED EVOLUTION SHORTIE, EVOLUTION11, AND EVOLUTION13 TO DISSECT THE CORONARY SINUS (CS), BUT THE ADHESION IN THE CS WAS SO STRONG THAT PHYSICIAN DECIDED TO SHIFT TO BYRD DILATOR SHEATH, JUDGING THAT HE COULD NOT REMOVE THE CS WITHOUT SOME DISSECTION INSIDE IT. HOWEVER, IT COULD NOT FOLLOW THE FLEXION AND KINKED. HE SWITCHED TO EVOLUTION 11 AGAIN, MAINTAINED THE SHEATH TIP NEAR THE CS, AND SLOWLY ROTATED AND APPLIED TRACTION, WHICH ALLOWED US TO REMOVE IT. IMMEDIATELY AFTERWARDS, THE BLOOD PRESSURE GRADUALLY DROPPED, PERICARDIAL FLUID ACCUMULATION WAS CONFIRMED, AND PERICARDIOCENTESIS WAS ATTEMPTED. AFTER OBSERVING THE PATIENT FOR ABOUT AN HOUR, IT WAS DETERMINED THAT THE PATIENT HAD STABILIZED AND A DECISION WAS MADE NOT TO PERFORM A THORACOTOMY.

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 22725602 ↗
• InjuryJun 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WE REPORT A CASE IN WHICH SUPERIOR VENA CAVA (SVC) INJURY OCCURRED USING THE FOLLOWING PRODUCTS: EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, STEADYSHEATH EVOLUTION® TISSUE STABILIZATION SHEATH, PHILIPPS/GLIDELIGHT 14FR, PHILIPPS/GLIDELIGHT 16FR, (IT IS UNCLEAR IN WHAT ORDER THE COOK PRODUCT EVOLUTION AND THE PHILIPS PRODUCT GLIDELIGHT WERE USED.) EACH ONE LEAD HAD BEEN PLACED IN THE RIGHT ATRIUM AND RIGHT VENTRICLE. AFTER REMOVAL OF THE ATRIAL LEAD, DURING DISSECTION OF THE AREA AROUND THE SVC FOR REMOVAL OF THE VENTRICULAR LEAD, THE PATIENT BLED AND BECAME HYPOTENSIVE; AN ATTEMPT WAS MADE TO STOP THE BLEEDING WITH A PHILIPPS/BRIDGE OCCULUSION BALLOON, FOLLOWED BY OPEN CHEST SURGERY, WHICH REVEALED AN INJURY OF THE SVC.

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

  MAUDE report 22151454 ↗
• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEAD REMOVAL WAS ATTEMPTED WITH COOK DEVICES (EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SETS AND NEEDLE¿S EYE SNARE) AND NON-COOK LASER SHEATHS (14F, 16FR). WHEN THE USER ATTEMPTED TO REMOVE A LONG-TERM PLACED ATRIAL LEAD, THE BLOOD PRESSURE DECREASED. THE USER DETERMINED THAT CARDIAC TAMPONADE OCCURRED TO OPEN THE CHEST. THE PATIENT CONDITION AFTER OPENING THE CHEST IS STABLE.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension

  MAUDE report 21696336 ↗
• InjurySep 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER THE PROCEDURE, THE PATIENT HAD TO UNDERGO SURGERY BECAUSE OF A BLOOD HEMORRHAGE. AFTER THE SURGERY THE USER SAID THAT THE BLOOD COULD HAVE COME FROM THE VENA AND COULD HAVE BEEN CAUSED BY OUR PRODUCT. ONCE EXTRACTED ATRIAL PACEMAKER WITHOUT ANY PROBLEM DURING FIBROLISIS WITH EVOLUTION 11.0 LONG SHAFT, IT OCCURRED HEMORRHAGE (PERICARDIAL TAMPONADE). AFTER PERICARDIOCENTESIS, PATIENT HAS BEEN TRANSFERRED IN OPERATING ROOM TO CARDIAC SURGEONS THAT FOUND A SEVERE DAMAGE ON SUPERIOR VENA CAVA THAT THEY REPAIRED.

  Patient problems: Great Vessel Perforation; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20339377 ↗
• InjuryAug 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ANATOMY BEFORE SURGERY AND AT THE TIME OF FAILURE: PACEMAKER LEADS HAD BEEN PLACED IN THE RIGHT ATRIUM AND RIGHT VENTRICLE VIA THE LEFT SUBCLAVIAN VEIN RESPECTIVELY. THE RIGHT ATRIUM WAS APPROACHED VIA THE LEFT SUBCLAVIAN VEIN. WHILE REMOVING ADHESIONS NEAR THE TIP OF THE RIGHT ATRIAL LEAD USING THE LR-EVN-11.0-RL, IT WAS NOTICED THAT THE PATIENT'S HEART WAS MOVING SLOWLY, AND FLUOROSCOPIC IMAGES SUGGESTED THAT PERICARDIAL FLUID HAD ACCUMULATED. A CARDIAC SURGEON IMMEDIATELY INTERVENED AND DRAINED THE PERICARDIAL FLUID WITHOUT A THORACOTOMY. AFTER DRAINAGE AND HEART START, THE ATRIAL LEAD WAS SUCCESSFULLY REMOVED.

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 20002750 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EXTRACTION. HOLE IN ATRIAL APPENDAGE. CHEST OPENED. 2 STITCHES. PATIENT IS FINE. CAUSE OF HOLE PASSIVE LEAD. ALTHOUGH THE WHOLE EXTRACTION KIT WAS USED, THE PASSIVE LEAD CAUSED THE HOLE. THE PASSIVE LEADS CAUSED A HOLE IN THE ATRIAL APPENDAGE. NO EQUIPMENT WAS AT FAULT. PATIENT IS FINE AND RECOVERING.

  Patient problems: Cardiac Perforation; Internal Organ Perforation

  MAUDE report 18366588 ↗
• InjuryJun 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUPERIOR VENA CAVA (SVC) WAS INJURED DURING THE PROCEDURE. AS PER CC FORM: TRANSVENOUS LEAD EXTRACTION (TLE) OF 10 YEARS OLD ST. JUDE LEADS. ISOLATION WAS ALREADY DAMAGED IN THE POCKET. PASSAGE THROUGH THE SUBCLAVIAN VEIN WAS VERY DIFFICULT BECAUSE OF STRONG CALCIFICATIONS UNDER THE CLAVICULAR BONE. BOTH LEADS STICKING TOGETHER AND HAD STRONG ADHESIONS AT THE SUPERIOR VENA CAVA (SVC) EVEN AT THE VENA ANONYMA. AFTER SOFT TRACTION LEAD BUNDLE JUMPED UP AND ATRIAL LEAD SCRATCHED THE SVC WITH AN IN-CONSEQUENCE CA 5 MM TEAR AND MODERATE BLEEDING INTO THE MEDIASTINUM . AFTER BLOCKING THE SVC DIFFERENT SHORT TIMES THE BLEEDING STOPPED AND AN IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) LEAD IS IMPLANTED. AFTER A FOLLOWING CONTROL UNDER COMPUTED TOMOGRAPHY (CT) A SMALL BLEEDING IS DETECTED AND PATIENT IS TRANSFERRED TO A HEART SURGERY DEPT. OF (B)(6) HOSPITAL.

  Patient problems: Great Vessel Perforation

  MAUDE report 17163557 ↗
• InjuryMay 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TRANSVENOUS LEAD EXTRACTION WAS PERFORMED BY SUBCLAVIAN VEIN APPROACH TO EXTRACT VDD LEAD WHICH HAD BEEN IMPLANTED IN THE LEFT PRECORDIUM IN 2002 AND ANOTHER VDD LEAD WHICH HAD BEEN IMPLANTED IN THE RIGHT PRECORDIUM IN 2006. THE LEAD EXTRACTION FROM THE RIGHT PRECORDIUM WAS PERFORMED FIRST, AND IT WAS SUCCESSFULLY COMPLETED WITHOUT ANYTHING REMAINED. THE LEAD EXTRACTION FROM THE LEFT PRECORDIUM WAS PERFORMED NEXT WITH USING THE FOLLOWING DEVICES IN THE FOLLOWING ORDER; LR-EVN-SH-9.0-RL/ N186173 --> LR-EVN-11.0-RL/ N181031 + LR-TSS-11.0/ N178695 --> GLIDELIGHT 16FR BY PHILIPS --> LR-NES002/ N179246 --> OSYPKA SNARE CATHETER (FORCEPS TYPE) BY HIEWA BUSSAN. AS THE ANESTHESIOLOGIST WAS PERFORMING LEAD EXTRACTION FROM THE LEFT PRECORDIUM, A TRANSESOPHAGEAL ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION, AND CARDIAC TAMPONADE WAS SUSPECTED. A CARDIOVASCULAR SURGEON IMMEDIATELY OPENED THE CHEST AND INSERTED A DRAIN. HE CHECKED THE DAMAGED AREA AND FOUND THAT THE BLEEDING HAD STOPPED. A SMALL DENT WAS FOUND NEAR THE AURICLE OF RIGHT ATRIUM, WHICH WAS DETERMINED TO BE THE SOURCE OF THE BLEEDING. THE PATIENT WAS RETURNED TO THE INTENSIVE CARE UNIT (ICU) WITH HEMOSTATIC TAPE (TACHOSIL) APPLIE

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 14547978 ↗
• DeathMay 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TRANSVENOUS LEAD EXTRACTION WAS PERFORMED BY SUBCLAVIAN VEIN APPROACH TO EXTRACT THE RA LEAD WHICH HAD BEEN IMPLANTED IN THE LEFT SIDE ON (B)(6) 2011. PHILIP¿S GLIDELIGHT 14FR WAS ADVANCED THROUGH THE SUPERIOR VENA CAVA (SVC) TO PEEL OFF THE ADHESION, THEN IT WAS CHANGED WITH COOK¿S EVOLUTION 11FR AT A CERTAIN POINT OF THE SVC. WHEN THE USER WAS PEELING OFF THE ADHESION NEAR THE TRICUSPID VALVE WITH THE EVOLUTION, BLOOD PRESSURE DROPPED; APPROXIMATELY AT 16:20, BLOOD PRESSURE CHANGED AS 50¿S --> 40¿S --> IMPOSSIBLE TO MEASURE, SO TRANSESOPHAGEAL ECHOCARDIOGRAPHY WAS IMMEDIATELY PERFORMED TO CONFIRM PERICARDIAL EFFUSION. THE ANESTHESIOLOGIST ADMINISTERED CATECHOLAMINE TO MAINTAIN BLOOD PRESSURE AROUND 60-70. A CARDIOVASCULAR SURGEON (DR. (B)(6)) IMMEDIATELY CAME TO HELP, THEN CONTINUOUS AUTOTRANSFUSION MACHINE AND PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS) WERE USED AT THE SAME TIME ACCORDING TO HIS INSTRUCTION. APPROXIMATELY AT 16:30, A MEDIAN STERNOTOMY WAS PERFORMED AND THE DAMAGED AREA WAS REPAIRED. DURING THE OPERATION, THE PATIENT WAS CONNECTED TO A HEART-LUNG MACHINE AS SOON AS IT WAS READY. 20 UNITS OF RED BLOOD CELLS (RBC) AND 8 UNITS OF FRESH FROZEN PLASMA (FFP) WERE ADMI

  Patient problems: Great Vessel Perforation

  MAUDE report 14461453 ↗
• InjuryMar 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A SVC TEAR AND BLOOD PRESSURE DROP DURING A LEAD EXTRACTION PROCEDURE. REMOVAL OF THE ICD LEAD COMMENCED USING THE EVOLUTION 11FR SHORTIE TO PEEL OFF THE ADHESION AT THE INSERTION AREA, THEN EVOLUTION 11FR RL (LR-EVN-11.0-RL) WAS ADVANCED TO NEAR THE ENTRANCE OF THE SVC TO PEEL OFF THE ADHESION. A PHILIP'S GLIDELITE 12FR WAS THEN USED AND THE PATIENT'S BLOOD PRESSURE BEGAN TO DROP. DEVICE USER TEMPORARILY CONDUCTED HEMOSTATIC TREATMENT WITH A BALLOON CATHETER (BRIDGE OCCLUSION BALLOON CATHETER/ PHILIP) AND THEN PERFORMED ON-PUMP THORACOTOMY FOR HEMOSTASIS AND THE THREE REMAINING LEADS (THE VENTRICLE LEAD IN THE RIGHT AND THE LEFT ATRIAL AND VENTRICLE LEADS) WERE REMOVED AND THE INCISION WAS CLOSED. THE PATIENT WAS RETURNED TO THE ICU. THE SEVERITY OF THE COMPLICATION AND THE PATIENT'S CONDITION HAVE NOT BEEN SUPPLIED.

  Patient problems: Great Vessel Perforation

  MAUDE report 13827290 ↗
• InjuryMar 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO COOK THAT A LEAD EXTRACTION PROCEDURE WAS PERFORMED AT (B)(6)HOSPITAL ON (B)(6) 2022. THE PATIENT HAD 23 YEAR OLD LEADS IN PLACE. DURING THE PROCEDURE, A PERICARDIAL EFFUSION/TAMPONADE OCCURRED SO A PERICARDIOCENTESIS SET WAS USED TO DRAIN THE PERICARDIAL EFFUSION. PROCEDURE WAS COMPLETED AND IT WAS REPORTED THAT THE PATIENT RECOVERED.

  Patient problems: Cardiac Tamponade

  MAUDE report 13659680 ↗
• DeathJun 4, 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 DUE TO A RECURRENT ICD POCKET INFECTION WITH PERFORATION OF THE POCKET. BEFORE THE LEAD EXTRACTION PROCEDURE WAS STARTED, A TRANSITIONAL PACING LEAD WAS POSITIONED AFTER SEVERAL UNSUCCESSFUL ATTEMPTS. THE PATIENT HAD DIFFICULT ANATOMY, NOTABLY A PERSISTENT VENA CAVA. THE FIRST TARGETED LEAD WAS A FIVE-YEAR-OLD ATRIAL LEAD (MEDTRONIC CAPSUREFIX NOVUS MRI 5076-52). AFTER UNSUCCESSFUL ATTEMPTS TO TURN BACK THE LEADS SCREWED IN CONNECTION TO THE ATRIUM, THE CONNECTOR WAS FINALLY CUT AND A LIBERATOR LOCKING STYLET WAS PLACED. A ONE-TIE COMPRESSION COIL WAS ALSO WRAPPED AROUND THE LEAD. PRODUCTS WORKED AS EXPECTED. EXTRACTION WAS SUCCESSFUL BY PULLING THE ATRIAL LEAD. AT THE TRANSITION TO THE RIGHT VENA BRACHIOCEPHALIC VEIN, A SCREW BECAME BRIEFLY STUCK, THEN THE LEAD SLIPPED OUT EASILY. THE SECOND TARGETED LEAD WAS A FIVE-YEAR-OLD ICD LEAD (MEDTRONIC SPRINT QUATRO S 6935). AFTER UNSUCCESSFUL ATTEMPTS TO TURN BACK THE LEADS SCREWED IN CONNECTION TO THE VENTRICLE, THE CONNECTOR WAS CUT, A LIBERATOR LOCKING STYLET WAS PLACED AND A ONE-TIE COMPRESSION COIL WAS WRAPPED AROUND THE LEAD. PRODUCTS WORKED AS EXPECTED. EX

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 11939357 ↗
• InjuryMar 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE REMOVAL OF TWO NON-FUNCTIONAL LEADS, A LACERATION OF THE SUPERIOR VENA CAVA OCCURRED. THE COMPLAINT DEVICE, COOK LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET (PRODUCT CODE: DRE, RPN: LR-EVN-11.0-RL), ALONG WITH COOK CONCOMITANT DEVICES WERE USED DURING THE PROCEDURE: EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET (LR-EVN-SH-9.0-RL), STEADYSHEATH EVOLUTION SHORTIE TISSUE STABILIZATION SHEATH (LR-TSS-SH-9.0), AND STEADYSHEATH EVOLUTION TISSUE STABILIZATION SHEATH (LR-TSS-11.0). BOTH LEADS WERE IMPLANTED IN THE RIGHT ATRIUM FROM THE LEFT CHEST THROUGH THE SUBCLAVIAN VEIN. A VESSEL LACERATION OCCURRED WHILE THE COMPLAINT DEVICE WAS BEING USED; THE PHYSICIAN SUSPECTED THAT A LACERATION HAD OCCURRED. A VASCULAR SURGEON WAS ON STANDBY, SO THE PATIENT WAS MOVED TO SURGERY IMMEDIATELY. A THORACOTOMY WAS PERFORMED, AND A LACERATION OF THE SUPERIOR VENA CAVA WAS CONFIRMED. THE BLEEDING WAS STOPPED, AND THE PATIENT STABILIZED. NO COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: Great Vessel Perforation

  MAUDE report 11555932 ↗
• DeathFeb 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DR. (B)(6) STATED HE WOULD LIKE TO REPORT AN ADVERSE EVENT HAPPENED AFTER USE OF EVOLUTION RL DURING LEAD EXTRACTION. AFTER SUCCESSFUL EXPLANATION WITH LR-EVN-RL 11FR. AND WOUND CLOSURE, BLOOD PRESSURE DROP, TRANS-ESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED WHICH REVEALED EXCESSIVE FLUID ACCUMULATION AROUND THE HEART CONSISTENT WITH CARDIAC TAMPONADE, DRAINAGE WAS NOT SUCCESSFUL. THORACOTOMY IMMEDIATELY PERFORMED AND THE PERFORATION OF THE HEART WALL WAS SUTURED SUCCESSFULLY. EVERYTHING WAS STABLE, WHILE CLOSING THE WOUND, HOWEVER, PATIENT DIED BECAUSE OF EXCESSIVE BLOOD LOSS AND WEAK HEART. DR. (B)(6) IS AWARE THAT ANY OTHER PROCEDURE COULD HAVE CAUSED THIS COMPLICATION. HE DOESN'T BLAME OUR DEVICE.

  Patient problems: Cardiac Tamponade; Death

  MAUDE report 9682072 ↗
• DeathOct 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHILE EXTRACTING 25-YEAR-OLD PACEMAKER LEADS FROM THE RIGHT HAD SIDE OF THE HEART, THE PATIENT¿S SUPERIOR VENA CAVA RUPTURED. OPEN SURGERY WAS PERFORMED, AND THE PATIENT RECOVERED HEMODYNAMICALLY, BUT BRAIN DEATH WAS PROCLAIMED BY ANESTHETIST. ACCORDING TO THE INITIAL COMPLAINT NOTES, THE SURGEONS HAVE NO COMPLAINTS REGARDING THE PRODUCTS OR THEIR USE, AND DO NOT ATTRIBUTE THE DEATH IN ANY WAY TO COOK PRODUCTS.

  Patient problems: Death; Perforation of Vessels

  MAUDE report 9263075 ↗
• InjuryJun 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THE LEAD EXTRACTION PROCEDURE WAS PERFORMED WITH COOK'S EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET (LR-EVN-11.0-RL), A SPECTRANETICS 12FR GLIDELIGHT LASER SHEATH, AND SPECTRANETICS LEAD LOCKING DEVICE (LLD EZ). THE PHYSICIAN EXTRACTED THE LEAD WITH THE EVOLUTION DEVICE BUT RIGHT CARDIAC ATRIAL TISSUE CAME OFF WITH THE TISSUE THAT ADHERED TO THE RIGHT ATRIAL LEAD AND A HOLE WAS MADE IN THE RIGHT CARDIAC ATRIUM. IMMEDIATELY AFTER THE EVENT, THE PATIENT'S BLOOD PRESSURE DROPPED SIGNIFICANTLY. THEREFORE, PERICARDIAL DRAINAGE WAS PERFORMED, ALONG WITH A BLOOD TRANSFUSION AND PERCUTANEOUS CARDIOPULMONARY SUPPORT. HOWEVER, THE SITUATION DID NOT CHANGE, SO THE PROCEDURE WAS CONVERTED TO OPEN HEART SURGERY. CURRENTLY THE PATIENT IS UNDER TREATMENT AT ICU AND IS RESPONDING TO VERBAL CONTACT. AFTERWARDS THE PHYSICIAN COMMENTED, "I THINK THIS IS THE ONE OF THE COMPLICATIONS THAT MAY OCCUR BY THE PROCEDURE. IT IS NOT DUE TO DEVICE(EVOLUTION) FAILURE."

  Patient problems: Atrial Perforation; Cardiac Tamponade; Low Blood Pressure/ Hypotension

  MAUDE report 8734438 ↗
• DeathMay 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO NEW EVENT INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT.

  Patient problems: Death; Low Blood Pressure/ Hypotension; Perforation of Vessels

  MAUDE report 8594684 ↗
• InjuryMar 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO CUSTOMER RELATIONS: "THE 11FR COOK EVOLUTION TOOL WAS ADVANCED, LEAD WAS REMOVED AND PATIENT. HAD HYPOTENSIVE EPISODE. PERICARDIAL CENTESIS WAS DONE, CPR BEGUN, PERICARDIAL WINDOW DONE."

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 8451500 ↗
• InjuryDec 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED DURING A CARDIAC LEAD EXTRACTION PROCEDURE, THE LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET WAS USED TO REMOVE THE LEAD. DURING ACTIVATION AT TRANSITION VENA CAVA SUPERIOR/RIGHT ATRIUM, THE EVOLUTION RL DAMAGED THE RA LEAD. THE LEAD WAS REMOVED SUCCESSFULLY BUT RIGHT AFTER THE TENSION DROPPED, AND AN ULTRASOUND REVEALED A PERICARDIAL EFFUSION. A PERICARDIAL PUNCTURE WAS UTILIZED TO DRAIN BLOOD AND A THORACOTOMY TO SUTURE THE PERFORATION WAS USED TO STOP THE BLEEDING. NO UNINTENDED PORTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. NO REPORTED FURTHER ADVERSE EVENTS AFTER THE COMPLETION OF THE EVENT.

  Patient problems: Blood Loss; Pericardial Effusion

  MAUDE report 7123856 ↗
• InjuryAug 3, 2015Break; Lead(s), breakage of

  DURING A REMOVAL OF A PACEMAKER AND 3 LEAD EXTRACTIONS FOR THE RIGHT SIDE OF THE SUBCLAVIAN AREA, THE LOCKING STYLET COULD NOT BE MOVED FORWARD TO THE LEAD TIP. THERE WAS AN EXTREME SHARP CURVE OVER A RIB. THE LEAD BROKE AND THEN BLOOD PRESSURE LOSS OCCURRED. OPEN HEART SURGERY WAS DONE AND AFTER SUTURING A SMALL HOLE IN THE SUBCLAVIA/SVC CONJUNCTION, THE RIGHT ATRIUM WAS OPENED TO REMOVE THE LEADS SUCCESSFULLY. THE PATIENT LEFT OR IN NORMAL CONDITION. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Low Blood Pressure/ Hypotension; No Code Available

  MAUDE report 4977065 ↗
• InjuryJun 4, 2015Adverse Event Without Identified Device or Use Problem

  AN (B)(6) PT WITH AN INFECTED PACEMAKER UNDERWENT TWO LEADS EXTRACTION PROCEDURE FROM THE LEFT SIDE SUBCLAVIA INTO THE RIGHT ATRIAL VENTRICLE. THE EXTRACTION WAS 100%SUCCESSFUL. THE VENTRICULAR LEAD WAS EXTRACTED WITHOUT ANY COMPLICATIONS. AFTER EXTRACTION OF THE ATRIAL LEAD, THE TRANSESOPHAGEAL ECHOCARDIOGRAM SHOWED BLEEDING INTO THE PERICARDIUM AND SOME SECONDS LATER A BLOOD PRESSURE LOSS FROM AROUND 110 TO 50 OCCURRED. THE SURGEON OPENED THE CHEST BY PERFORMING A MINITHORACOTOMY AND SUCKED OFF THE BLOOD THROUGH THE SLOT IN BETWEEN TWO RIBS FROM THE PERICARDIUM. THE RESULT WAS THAT THE BLOOD PRESSURE RETURNED TO NORMAL VALUES. THE SURGEON NOTICED A FRACTURE OF AROUND TWO CENTIMETERS AT THE BEGINNING OF THE VENA CAVA INFERIOR. THIS WAS SUTURED BY THE SURGEON WITHOUT USE OF A HEART LUNG MACHINE, BUT BY USING A CELL SAVER FOR REGAINING THE BLOOD DURING THE THORACOTOMY. THE SURGEON'S OPINION IS THAT THE EVENT OCCURRED DUE TO THE LEADS BEING IMPLANTED FOR 27 YEARS AND CONSIDERS THE INCIDENT AS A NORMAL RISK. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY.

  Patient problems: Bleeding; Surgical procedure, additional; Unspecified Infection

  MAUDE report 4827599 ↗