WATCHMAN® M635WU27060Recalls & reported problems

Summary

The FDA's MAUDE database contains 483 adverse event reports that list this exact device (DI 08714729838241), received between Nov 21, 2016 and Apr 9, 2024 — classified as 45 deaths, 394 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (24 reports).

2 other recalls cover devices cleared under the same FDA submission (P130013); they may or may not involve this specific model.

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 25 most recent of 483 reports, in the reporter's own words as published by the FDA.

• DeathApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS ENROLLED IN THE ASAP TOO STUDY WITH PATIENT IDENTIFIER (B)(6) ON (B)(6) 2020. IT WAS REPORTED THAT DEATH OCCURRED. A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE WAS PERFORMED ON (B)(6) 2020. INITIALLY, A 24MM WATCHMAN CLOSURE DEVICE WAS ATTEMPTED, HOWEVER RELEASE CRITERIA WERE NOT MET, AND IT WAS REMOVED AND EXCHANGED FOR A SECOND 24MM WATCHMAN CLOSURE DEVICE. AGAIN, RELEASE CRITERIA WERE NOT MET, AND IT WAS REMOVED AND EXCHANGED FOR A 27MM WATCHMAN CLOSURE DEVICE WHICH WAS SUCCESSFULLY IMPLANTED AT THE LAA WITH A COMPLETE SEAL AND DEPLOYED DIAMETER OF 23MM. THE PATIENT WAS DISCHARGED (B)(6) 2020. ON AN UNKNOWN DATE, UNKNOWN DAYS POST-INDEX PROCEDURE, THE PATIENT DIED. IT WAS FURTHER REPORTED THAT THE PATIENT DIED APPROXIMATELY 4 YEARS POST-IMPLANT ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19071447 ↗
• InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS ENROLLED IN THE ASAP TOO STUDY ON (B)(6) 2019 WITH PATIENT IDENTIFIER (B)(6). IT WAS REPORTED THAT TRANSIENT ISCHEMIC ATTACK (TIA) OCCURRED. ON (B)(6) 2019, A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND THE PATIENT UNDERWENT SUCCESSFUL PLACEMENT OF A 27 MM WATCHMAN CLOSURE DEVICE WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 23.9 MM. POST IMPLANT THE PATIENT WAS PRESCRIBED ASPIRIN AND CLOPIDOGREL AND WAS DISCHARGED THE NEXT DAY. THREE DAYS POST IMPLANT, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH LEFT SIDED WEAKNESS, RIGHT OCULAR CHANGES AND LEFT ARM TINGLING/NUMBNESS WHICH HAD BEEN WAXING AND WANING. THE PATIENT WAS HOSPITALIZED FOR FURTHER EVALUATION ON THE SAME DAY. THE PATIENT'S SYMPTOMS RESOLVED PRIOR TO HOSPITAL ADMISSION. THE PATIENT WAS IMMEDIATELY STARTED ON A HEPARIN DRIP. THE SAME DAY THE PATIENT WAS EVALUATED BY A NEUROLOGIST. NEUROLOGY EXAMINATION NOTED THE PATIENT TO BE ALERT, ORIENTED, WITH CRANIAL NERVE ASSESSMENT INTACT AND MOTOR ASSESSMENT SHOWING LEFT PRONATOR DRIFT. COMPUTED TOMOGRAPHY OF THE HEAD REVEALED NO ACUTE PARENCHYMAL HEMORRHAGE OR LARGE CORTICAL INFARCT. MAGNETIC RESONANCE IMAGING (MRI) OF THE

  Patient problems: Transient Ischemic Attack

  MAUDE report 18912423 ↗
• InjuryMay 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASAP TOO STUDY. IT WAS REPORTED THAT A CEREBRAL VASCULAR ACCIDENT OCCURRED. PRIOR TO THE PROCEDURE, ASPIRIN AND CLOPIDOGREL WERE ADMINISTERED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) AND A 27MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED TO BE USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE CLOSURE DEVICE IMPLANTED IN THE LAA OF THE PATIENT WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 22.2 MM. THE PATIENT REMAINED ON ASPIRIN AND CLOPIDOGREL POST PROCEDURE. THE PATIENT WAS DISCHARGED ON (B)(6)2019. 1251 DAYS POST PROCEDURE, THE PATIENT WAS NOTED TO HAVE A PROXIMAL DESCENDING AORTIC ANEURYSM. ON THE SAME DAY THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR FURTHER EVALUATION AND TREATMENT. THE PATIENT UNDERWENT PROXIMAL DESCENDING AORTIC ANEURYSM REPAIR SURGERY. POST SURGERY THE PATIENT WAS ALSO NOTED WITH PNEUMONIA AND SUB-ACUTE LEFT CEREBELLAR INFARCTION. 1255 POST INDEX PROCEDURE COMPUTED TOMOGRAPHY OF THE PATIENT'S HEAD REVEALED A SUB-ACUTE LEFT CEREBELLAR INFARCTION. TEN DAYS LATER THE SUB-ACUTE LEFT CEREBELLAR INFARCTION EVENT WAS CONSIDERED AS RESOLVED AND THE PATIENT WAS DISCHARG

  Patient problems: Stroke/CVA

  MAUDE report 16886190 ↗
• InjuryMay 4, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DEVICE DID NOT SEAL. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 27MM WATCHMAN CLOSURE DEVICE WAS IMPLANTED. THE PATIENT WAS PART OF A CLINICAL TRIAL FOR HEART VALVE REPAIRS. WHILE BEING EVALUATED FOR POST-OPERATIVE VALVE REPAIR, THE PATIENT WAS INFORMED THAT THE WATCHMAN WAS LEAKING. THE PATIENT WAS STARTED ON ELIQUIS AND REFERRED TO A PHYSICIAN WITH WATCHMAN EXPERIENCE AT A DIFFERENT FACILITY. THE PATIENT IS SCHEDULED TO MEET WITH THE PHYSICIAN IN A COUPLE WEEKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16870336 ↗
• InjuryFeb 16, 2023Difficult to Open or Close; Material Integrity Problem; Difficult to Open or Close; Material Integrity Problem

  IT WAS REPORTED THAT A DEVICE FAILURE TO SEAL AND SUSPECTED IMPLANT FABRIC DAMAGE OCCURRED. IN (B)(6) 2019, A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED USING A 27MM WATCHMAN LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS). IN (B)(6) 2023 DURING A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) FOR A PULMONARY HYPERTENSION FOLLOW UP EXAMINATION, A 2MM PERI DEVICE LEAK WAS NOTED. THE FABRIC OF THE CLOSURE DEVICE SHOWED VISIBLE SURFACE DISCONTINUITY AND FLOW WAS NOTED INTO THE LAA THROUGH THE CLOSURE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16388746 ↗
• InjuryFeb 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 27MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. THE PATIENT WAS DISCHARGED ON ELIQUIS 5MG TWICE A DAY. THE PATIENT FOLLOWED THIS REGIMEN UNTIL ELIQUIS WAS REMOVED AND DUAL ANTIPLATELET THERAPY WAS ADDED. THE PATIENT WAS TO BE CARDIOVERTED, AND PRE-TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) PERFORMED 1129 DAYS POST IMPLANT PROCEDURE SHOWED A LAMINAR, NON-MOBILE, DEVICE RELATED THROMBUS ON THE FACE OF THE CLOSURE DEVICE. THE PATIENT WAS PLACED BACK ON XARELTO IN RESPONSE TO THE THROMBUS AND IS EXPECTED TO FULLY RECOVER.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16313569 ↗
• InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DEVICE RELATED THROMBUS OCCURRED. IN (B)(6) 2022, A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED USING A 24MM WATCHMAN FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS). IN (B)(6) 2022, THE PATIENT PRESENT TO THE HOSPITAL WITH CHEST PAIN. TRANSESOPHAGEAL ECHOCARDIOGRAM REVEALED A THROMBUS ON THE SURFACE OF THE CLOSURE DEVICE. ORAL ANTICOAGULANT MEDICATION WAS ADMINISTERED. IN (B)(6) 2023, A THROMBECTOMY WAS PERFORMED. THE PATIENT FULLY RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL. IT WAS FURTHER REPORTED THE LAA CLOSURE PROCEDURE TOOK PLACE IN (B)(6) 2020. THE CLOSURE DEVICE WAS NOTICEABLY TILTED WITH A LARGE MITRAL SHOULDER BUT NO PERI DEVICE LEAK WAS PRESENT. DURING A ROUTINE FOLLOW UP EXAMINATION IN (B)(6) 2022, A DEVICE RELATED THROMBUS WAS IDENTIFIED. THE PATIENT WAS RESTARTED ON ELIQUIS. BY (B)(6) 2022, THE NON MOBILE THROMBUS HAD NOT RESOLVED AND A THROMBECTOMY WAS PERFORMED IN (B)(6) 2023.

  Patient problems: Chest Pain; Thrombosis/Thrombus

  MAUDE report 16197026 ↗
• InjuryJun 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A DEVICE RELATED THROMBUS. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A 27MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE CLOSURE DEVICE IMPLANTED IN THE LAA OF THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS THAT WERE REPORTED TO HAVE OCCURRED. THE PATIENT CAME IN FOR A FOLLOW UP TRANSESOPHAGEAL ECHOCARDIOGRAM(TEE) PROCEDURE. THE IMAGING SHOWED THAT THERE WAS A SMALL THROMBUS ON THE FACE OF THE CLOSURE DEVICE. THE PATIENT WAS RESTARTED ON ELIQUIS. 3 MONTHS LATER THE PATIENT HAD A FOLLOW UP TEE PROCEDURE THAT SHOWED THAT THE THROMBUS WAS NO LONGER PRESENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 14645509 ↗
• InjuryMay 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TRANSIENT ISCHEMIC ATTACK (TIA) OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 27MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. ONE THOUSAND TWO HUNDRED SEVENTY (1270) DAYS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED A TIA. A TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS NOT PERFORMED DUE TO CONCERN WITH THE ESOPHAGEAL STRICTURES OF THE PATIENT. A COMPUTED TOMOGRAPHY (CT) SCAN WAS INSTEAD PERFORMED, WHICH SHOWED THE CLOSURE DEVICE IN GOOD POSITION WITH NO THROMBUS AND A MAXIMUM LEAK OF 3MM. THE PATIENT FULLY RECOVERED FROM THE TIA AND WAS DISCHARGED.

  Patient problems: Transient Ischemic Attack

  MAUDE report 14289442 ↗
• InjuryApr 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4). STUDY. IT WAS REPORTED THAT A CEREBRAL VASCULAR ACCIDENT (CVA) OCCURRED. THE PATIENT WAS ENROLLED INTO THE (B)(4) STUDY ON (B)(6) 2018, AND THE PROCEDURE WAS PERFORMED SIXTY ONE (61) DAYS LATER. A 27MM WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 22.7MM. THE PATIENT WAS STARTED ON ASPIRIN AND CLOPIDOGREL FOLLOWING THE PROCEDURE. THE PATIENT WAS DISCHARGED ONE DAY POST INDEX PROCEDURE. THE PATIENT PRESENTED TO THE HOSPITAL ONE THOUSAND TWENTY ONE (1021) DAYS POST INDEX PROCEDURE DUE TO A HEADACHE. THE PATIENT ALLEGEDLY EXPERIENCED THE SYMPTOMS FOUR DAYS PRIOR TO ADMISSION ON (B)(6) 2021. PHYSICAL EXAMINATION REVEALED MODERATE HEADACHE IN THE LEFT PARIETAL AND LEFT TEMPORAL REGION. THE PATIENT WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT ON THE SAME DAY. SEVEN DAYS AFTER ADMISSION FOR A HEADACHE, A COMPUTED TOMOGRAPHY (CT) SCAN OF THE HEAD WITHOUT INTRAVENOUS (IV) CONTRAST REVEALED NO ACUTE INTRACRANIAL HEMORRHAGE. A LARGE AREA OF LOW ATTENUATION AT THE LEFT TEMPORAL LOBE AND POSTERIOR ASPECT OF THE LEFT PARIETAL LOBE WAS POTENTIAL REPRESENTATIVE OF AN ACUTE OR SUBACUTE INFARCT. AN ENHANCIN

  Patient problems: Headache; Stroke/CVA

  MAUDE report 13999369 ↗
• InjuryDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASAP TOO STUDY. IT WAS REPORTED THAT A TRANSIENT ISCHEMIC ATTACK (TIA) OCCURRED. THE PATIENT WAS ENROLLED INTO THE ASAP TOO CLINICAL STUDY ON (B)(6) 2017, AND THE PROCEDURE WAS PERFORMED TWENTY ONE DAYS LATER. A 27MM WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 22.6MM. THE PATIENT WAS ADMINISTERED ASPIRIN PRIOR TO THE INDEX PROCEDURE AND AFTER THE INDEX PROCEDURE, THE PATIENT WAS STARTED ON CLOPIDOGREL AND ASPIRIN WAS CONTINUED. THE PATIENT WAS DISCHARGED HOME THE FOLLOWING DAY. ONE THOUSAND FOUR HUNDRED FIFTY THREE (1453) DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY AFTER A FALL THAT OCCURRED 20 MINUTES PRIOR TO HOSPITALIZATION. THE PATIENT EXPERIENCED DIZZINESS AT HOME, LOST BALANCE, AND FELL. NO HEAD INJURY OR LOSS OF CONSCIOUSNESS WAS NOTED. THE PATIENT HAD SLURRED SPEECH AND FACIAL DROOP FOR ABOUT 20 MINUTES, WHICH WAS RESOLVED WHEN EARLY MEDICAL SERVICE ARRIVED. THE PATIENT DENIED ANY HEADACHE, BLURRED VISION, FACIAL ASYMMETRY, NUMBNESS, OR WEAKNESS. THE PATIENT WAS ALERT AND ORIENTED UPON ADMISSION WITHOUT ANY ACUTE DISTRESS. THE PATIENT'S NIHSS SCORE WAS 0. THE BASELINE NIHSS SCORE

  Patient problems: Transient Ischemic Attack

  MAUDE report 13014243 ↗
• InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A 27MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE CLOSURE DEVICE BEING IMPLANTED IN THE LAA OF THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS THAT WERE REPORTED TO HAVE OCCURRED. THE PATIENT WAS ON XARELTO AND PLAVIX FOR A POST PROCEDURE MEDICATION REGIMENT. SIX MONTHS POST PROCEDURE IT WAS NOTED ON CARDIAC COMPUTED TOMOGRAPHY (CT) THAT THERE WAS A DEVICE RELATED THROMBUS. THE PATIENT HAD BEEN OFF THEIR MEDICATION REGIMENT AND AT THE TIME THE THROMBUS WAS NOTED THEY WERE PUT ON XARELTO AND ASPIRIN. IT WAS FURTHER REPORTED THAT THE PATIENT HAD ANOTHER CT PROCEDURE 9 MONTHS POST PROCEDURE. THE IMAGING SHOWED THAT THE DEVICE RELATED THROMBUS WAS STILL PRESENT. THE PATIENT IS DOING FINE AND WILL HAVE ANOTHER FOLLOW UP PROCEDURE IN 90 DAYS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12863138 ↗
• InjuryOct 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) STUDY. IT WAS REPORTED THAT A CEREBRAL VASCULAR ACCIDENT (CVA) OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 27MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. ON (B)(6) 2021, 782 DAYS POST INDEX PROCEDURE, THE PATIENT WAS NOTED WITH THE CHIEF COMPLAINT OF RIGHT FACE WEAKNESS AND THE INABILITY TO SPEAK. THE PATIENT'S HEALTH CONDITION CONTINUED TO DECLINE EVEN AFTER ALL THE MEDICAL TREATMENT AND NOTED WITH FLUCTUATION IN THE MENTAL STATUS. A STROKE CODE WAS CALLED. THE PATIENT WAS NOT A GOOD CANDIDATE FOR TPA DUE TO ACTIVE GASTROINTESTINAL BLEEDING AND WAS ALSO NOT A CANDIDATE FOR MECHANICAL THROMBECTOMY DUE TO PHYSICAL MEDICAL CONDITION. THE NEUROLOGIST WAS CONSULTED, AND IT WAS SUSPECTED THAT THE PATIENT HAD SUFFERED A LEFT MCA TERRITORY STROKE AND SUFFERED MULTIPLE STROKES IN BOTH HEMISPHERES BUT THAT REMAINED TO BE DETERMINED. THE NEUROLOGIST SUSPECTED THE EVENT WAS POSSIBLY RELATED TO LARGE VESSEL ATHEROSCLEROTIC DISEASE OR SOME OTHER MECHANISM. THE INITIAL COMPUTED TOMOGRAPHY (CT) SCAN OF THE HEAD WITHOUT CONTRAST WAS UNREMARKABLE FOR ACUTE INTRACRANIAL PROCESS AND MILD ATROPHY WITH MODERATE WHITE MATTER DISEASE. THE NEUROLOGIST RECOMMENDED

  Patient problems: Stroke/CVA

  MAUDE report 12597851 ↗
• InjurySep 17, 2021Difficult to Open or Close; Difficult to Open or Close

  THE PATIENT WAS ENROLLED IN THE (B)(6) CLINICAL STUDY ON (B)(6) 2020 WITH PATIENT IDENTIFIER RD (B)(6). IT WAS REPORTED THAT THE CLOSURE DEVICE DID NOT SEAL. MEDICAL HISTORY: AT THE TIME OF ENROLLMENT, THE SUBJECT HAD A MEDICAL HISTORY OF PAROXYSMAL ATRIAL FIBRILLATION FOR GREATER THAN ONE YEAR AND CHA2DS2-VASC SCORE OF 3, HYPERLIPIDEMIA, ATRIAL FIBRILLATION ABLATION USING THE CYRO TECHNIQUE (MOST RECENT: (B)(6) 2017), CORONARY ARTERY DISEASE, MITRAL VALVE REGURGITATION (TISSUE VALVE), TRICUSPID VALVE REGURGITATION (TISSUE VALVE), PULMONARY VALVE REGURGITATION (TISSUE VALVE) AND SEIZURES. PROCEDURE SUMMARY: PRIOR TO THE INDEX PROCEDURE, ASPIRIN WAS ADMINISTERED. A 30 MM WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE DEVICE (LOT# 25135645) WAS ATTEMPTED TO BE USED BUT WAS NOT SUCCESSFUL DUE TO RELEASE CRITERIA NOT MET (POSITION-TOO DISTAL), ANCHOR (STABILITY) AND SEAL. THE SUBJECT THEN UNDERWENT SUCCESSFUL PLACEMENT OF A 27 MM WATCHMAN LAA CLOSURE DEVICE (LOT# 25203490) WITH COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 19.3MM. AFTER THE IMPLANT PROCEDURE, THE SUBJECT WAS STARTED ON ASPIRIN AND CLOPIDOGREL. THE SUBJECT WAS DISCHARGED ONE DAY POST INDEX PROCEDURE. POST PROCEDURE EV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12488323 ↗
• InjurySep 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PERFORATION, PERICARDIAL EFFUSION, AND CARDIAC TAMPONADE OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. DURING PLACEMENT OF THE WATCHMAN TRUSEAL ACCESS SYSTEM (WAS) A 5F PIGTAIL CATHETER WAS PLACED IN THE LAA WITH DIFFICULTY DURING ADVANCEMENT OVER A STIFF GUIDEWIRE. THE INITIAL ATTEMPT AT DEPLOYMENT OF THE 27MM WATCHMAN LAA CLOSURE DEVICE WAS ABORTED BECAUSE SHEATH PLACEMENT WAS TOO PROXIMAL DURING UNSHEATHING. THE DEVICE WAS PARTIALLY DEPLOYED WITH THE FEET OF THE DEVICE MINIMALLY EXPOSED AND WAS RECAPTURED. AN EFFUSION SWEEP WAS PERFORMED AND THE SWEEP REVEALED A PERICARDIAL EFFUSION. AN ANGIOGRAM WAS PERFORMED AND PERFORATION WAS NOTED. INITIALLY, THE PATIENT'S VITAL SIGNS WERE STABLE BUT THEN BECAME HYPOTENSIVE. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR SURGICAL REPAIR. THERE WAS SUSPICION THAT THE DIFFICULT PLACEMENT OF THE PIGTAIL AND STIFF GUIDEWIRE CONTRIBUTED TO THE PERFORATION. ADDITIONALLY, THE TIP OF THE WAS WAS NOTED TO HAVE A TEAR. NO ADDITIONAL INFORMATION IS KNOWN AT THIS TIME. IT WAS FURTHER REPORTED THAT THE PATIENT WAS OUT OF BED THE MORNING AFTER SURGERY AND RECOVE

  Patient problems: Cardiac Tamponade; Perforation; Pericardial Effusion

  MAUDE report 12421764 ↗
• InjuryAug 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A 27MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE PROCEDURE WENT AS PLANNED AND WAS SUCCESSFULLY COMPLETED WITH THE CLOSURE DEVICE BEING IMPLANTED IN THE LAA OF THE PATIENT AFTER 1 PARTIAL RECAPTURE. THE TRANSSEPTAL CROSS WAS NOTED TO BE DIFFICULT AND TAKE EXTRA TIME. THE PATIENT DID WELL AND WAS STABLE FOR THE ENTIRE PROCEDURE. THERE WERE NO COMPLICATIONS THAT WERE REPORTED TO HAVE OCCURRED DURING THE PROCEDURE. SEVERAL HOURS POST PROCEDURE THE PATIENT BECAME UNSTABLE. THE PATIENT WAS EXPERIENCING A PERICARDIAL EFFUSION. THE PHYSICIAN DRAINED 275ML OF FLUID FROM THE PATIENT TO TREAT THE EFFUSION. THE DRAIN WAS LEFT IN THE PATIENT FOR 2 DAYS BEFORE IT WAS REMOVED. THE PATIENT WAS STABLE AND FULLY RECOVERED FROM THESE EVENTS WITH A PLAN TO BE DISCHARGED HOME FROM THE HOSPITAL.

  Patient problems: Pericardial Effusion

  MAUDE report 12313908 ↗
• InjuryAug 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 27MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. WARFARIN AND 81 MG OF ASPIRIN WAS PRESCRIBED FOR 6 WEEKS AFTER IMPLANT. THE 81 MG OF ASPIRIN WAS HELD FOR A FEW DAYS POST OP DUE TO THE CONCERN FOR GASTROINTESTINAL BLEEDING BUT WAS THEN RESTARTED. AT THE 6-WEEK FOLLOW-UP APPOINTMENT, WARFARIN WAS STOPPED AND 75MG OF PLAVIX WAS STARTED. THE PATIENT WAS TO REMAIN ON PLAVIX FOR A YEAR; HOWEVER, IT WAS STOPPED (B)(6) 2019 DUE TO WEAKNESS AND DYSPNEA. THE 81 MG OF ASPIRIN CONTINUED. APPROXIMATELY 23 MONTHS POST IMPLANT, THE PATIENT WAS ADMITTED FOR OTHER REASONS AND A DEVICE RELATED THROMBUS WAS NOTED. THE PATIENT WAS ADMITTED AFTER UNDERGOING COMPUTED TOMOGRAPHY PULMONARY EMBOLUS (CTPE) FOR DYSPNEA WHICH IDENTIFIED THE LEFT ATRIAL THROMBUS ATTACHED TO THE DEVICE. THE PATIENT UNDERWENT A TRANSTHORACIC ECHOCARDIOGRAM (TTE) THAT WAS NOT DEFINITIVE IN TERMS OF EVALUATING THE LEFT ATRIUM FOR IDENTIFICATION OF THE REPORTED THROMBUS. THE PATIENT WAS INITIATED ON HEPARIN AND LATER TRANSITIONED TO APIXABAN 5 MG TWICE DAILY. THE DECISION WAS MADE NOT TO LOAD PATIENT WITH 10 MG FOR 5 DAYS G

  Patient problems: Dyspnea; Thrombosis/Thrombus

  MAUDE report 12283046 ↗
• InjuryJun 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 27MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED ON (B)(6) 2021. AT THE PATIENT'S 45 DAY FOLLOW UP APPOINTMENT, A 1.3 X 1.1 CM THROMBUS WAS FOUND ON THE FACE OF THE WATCHMAN CLOSURE DEVICE VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). THE PATIENT NOTED THAT THEY MISSED A COUPLE OF DAYS OF TAKING THEIR ELIQUIS 5MG MEDICATION. SINCE THE PATIENT WAS NONCOMPLIANT WITH THE MEDICATION REGIMENT, THE PATIENT WAS SCHEDULED TO CONTINUE ON ELIQUIS 5MG TWICE A DAY WITH AN EMPHASIS ON NOT MISSING A DOSE. THE PATIENT WAS STABLE WITH NO SYMPTOMS FOLLOWING THIS EVENT AND IS SCHEDULED FOR FOLLOW UP TEE 3 MONTHS LATER.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11933784 ↗
• InjuryJun 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 27MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT WAS ADMITTED TO AN OUTSIDE HOSPITAL WITH COMPLAINTS OF DIZZINESS AND SHORTNESS OF BREATH. THE PATIENT WAS TREATED WITH ANTIBIOTICS DURING THIS HOSPITALIZATION. ON (B)(6) 2021, THE PATIENT CAME IN FOR A FOLLOW UP APPOINTMENT AT THE IMPLANTING FACILITY, HOWEVER, THERE WAS DIFFICULTY ADVANCING THE TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) PROBE, SO THE PROCEDURE WAS ABORTED. THE PATIENT WAS TRIED AGAIN ON (B)(6) 2021 WITH MORE ANESTHESIA. A THROMBUS WAS SEEN VIA TEE ON THE SURFACE OF THE WATCHMAN CLOSURE DEVICE AS THERE WAS EVIDENCE OF A HYPERECHOIC AREA OF 1.9 X 1.0 CM WITH FRIABILITY ALONG THIS SURFACE. THERE WAS NO EVIDENCE OF THROMBUS IN THE LEFT ATRIUM OR THE LEFT ATRIAL APPENDAGE. THE PATIENT WAS ON XARELTO 15MG PRIOR TO THE PROCEDURE, BUT WAS SWITCHED OVER TO WARFARIN 6MG. THE PATIENT WAS STABLE AND SCHEDULED FOR ADDITIONAL TEE IN 6 WEEKS FOR FOLLOW UP.

  Patient problems: Dizziness; Dyspnea; Thrombosis/Thrombus

  MAUDE report 11933772 ↗
• InjuryMay 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERFORATION AND A PERICARDIAL EFFUSION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A 27MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. UPON ASSESSING THE LAA WITH THE WAS, A KINK OCCURRED ON THE DISTAL END. THE DECISION WAS MADE TO CONTINUE USING THAT WAS AND NOT EXCHANGE IT. THE WDS WAS ADVANCED INTO THE WAS AND THE CLOSURE DEVICE WAS DEPLOYED. IMMEDIATELY FOLLOWING DEVICE DEPLOYMENT, THE DEVICE PERFORATED THE LAA LEADING TO A PERICARDIAL EFFUSION. THERE WAS NO INITIAL HEMODYNAMIC COMPROMISE NOTED FROM THE PERFORATION. THE DEVICE WAS LEFT IN PLACE AND IMPLANTED TO AVOID CAUSING A TEAR OR HOLE IN THE LAA AND TO ALLOW THE PERICARDIAL EFFUSION TO BE CONTROLLED. PROTAMINE WAS GIVEN AND A PERICARDIOCENTESIS WAS ATTEMPTED. A PNEUMOTHORAX OCCURRED DUE TO THE ATTEMPTED AND FAILED PERICARDIOCENTESIS AND A CHEST TUBE WAS INSERTED. THE PATIENT REMAINS HOSPITALIZED IN STABLE CONDITION WITH THE CHEST TUBE IN PLACE. THE PATIENT IS EXPECTED TO MAKE A FULL RECOVERY.

  Patient problems: Cardiac Perforation; Pericardial Effusion; Pneumothorax

  MAUDE report 11893627 ↗
• InjuryMay 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERICARDIAL EFFUSION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A 27MM WATCHMAN LAA CLOSURE DEVICE AND DELIVERY SYSTEM WAS DEPLOYED. IT DID NOT MEET THE RELEASE CRITERIA, SO IT WAS FULLY RECAPTURED. AT THAT TIME, A SMALL PERICARDIAL EFFUSION WAS NOTED. THE PERICARDIAL EFFUSION WAS MONITORED AND THE PATIENT REMAINED STABLE. THE DECISION WAS MADE TO STOP THE PROCEDURE, EXTUBATE THE PATIENT AND SEND THEM TO RECOVERY. NO INTERVENTION WAS NEEDED.

  Patient problems: Pericardial Effusion

  MAUDE report 11876796 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 27MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. UPON DISCHARGE ON (B)(6) 2020, THE PATIENT WAS PRESCRIBED XARELTO AND ASPIRIN. THE PATIENT DEVELOPED GASTROINTESTINAL BLEEDING ON (B)(6) 2020 AND WAS HELD FOR TWO DAYS. THE PATIENT RESUMED COUMADIN AND ASPIRIN ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT STOPPED COUMADIN AND STARTED PLAVIX AND ASPIRIN 81MG. ON (B)(6) 2020, THE PATIENT WAS UNWILLING TO COME IN FOR A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) OR SEE THE PHYSICIAN DUE TO COVID. ON (B)(6) 2020, THE PATIENT DISCONNECTED THEIR PHONE NUMBER AND DID NOT RESPOND TO FOLLOW UP REQUESTS FOR TEE AND TO CONFIRM COMPLIANCE WITH MEDICATION. ON (B)(6) 2021, THE PATIENT FOLLOWED UP WITH THE PHYSICIAN AND NOTED THE PATIENT WAS ONLY ON PLAVIX AT THE PATIENT'S OWN DOING. ON (B)(6) 2021, TEE WAS PERFORMED AND THROMBUS WAS FOUND ON THE WATCHMAN CLOSURE DEVICE. THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION ON COUMADIN WITH LOVENOX BRIDGING AND PLAVIX. THE PATIENT IS SCHEDULED TO HAVE REPEAT TEE IN 2-3 MONTHS. AS OF (B)(6) 2021, WAS REGULARLY ATTENDING AN ANTICOAGULATION CLINIC REGUL

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11842819 ↗
• InjuryMay 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 27MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. THE 45-DAY TRANSESOPHAGEAL ECHO (TEE) WAS UNREMARKABLE. THE PATIENT HAD SOME NEUROLOGICAL CHANGES WHICH PROMPTED A TEE IN MAY 2019 WHICH SHOWED A DEVICE RELATED THROMBUS. THE PATIENT WAS PUT BACK ON ORAL ANTICOAGULATION (ELIQUIS) AND THE CLOT RESOLVED. THE PATIENT CAME IN LAST WEEK WITH NEW NEUROLOGICAL CHANGES. A TEE WAS PERFORMED AND A NEW CLOT HAD FORMED ON THE FACE OF THE DEVICE MEASURING 16X5MM. THE PATIENT WAS PUT BACK ON ELIQUIS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11822536 ↗
• InjuryMay 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 27MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. TWENTY-FOUR HOURS POST PROCEDURE, A SMALL PERICARDIAL EFFUSION WAS FOUND. IT IS UNKNOWN HOW IT OCCURRED. A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS STABLE AND WAS DISCHARGED.

  Patient problems: Pericardial Effusion

  MAUDE report 11783276 ↗
• MalfunctionApr 26, 2021Difficult to Open or Close; Difficult to Open or Close

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11725467 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P130013. One submission often covers many models, so check the product and lot details in each record.

• Z-2766-2015 · Aug 25, 2015 · Terminated
  Boston Scientific, WATCHMAN Access System Access Sheath with Dilator, 14F Single curve( M635TU10060, TU1006) , 14F Double curve (M635TU20060, TU2006) , & 14F Anterior curve (M635
• Z-2765-2015 · Aug 25, 2015 · Terminated
  Boston Scientific, WATCHMAN Left Atrial Appendage Closure Device with Delivery System, 21mm x 12F ( M635WU21060, WU21060, 24mm x 12F(M635WU24060, WU2406) , 27mm x 12F(M635WU27060,