WATCHMAN® M635WU21060Recalls & reported problems

Summary

The FDA's MAUDE database contains 219 adverse event reports that list this exact device (DI 08714729838227), received between Nov 17, 2016 and Aug 15, 2025 — classified as 11 deaths, 197 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (16 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 219 reports, in the reporter's own words as published by the FDA.

• InjuryAug 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTED VIA PATIENT CALL CENTER. IT WAS REPORTED THAT PERICARDIAL EFFUSION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 21MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED ON (B)(6) 2020. THE PATIENT STATED THAT HE HAD PROBLEMS WITH WATCHMAN BEFORE, STATED THE CLOSURE DEVICE OPENED PREMATURELY AND NICKED THE SACK AROUND THE HEART. THE PATIENT STATED THAT HE WAS BLEEDING OUT AND REQUIRE EMERGENCY SURGERY. A GOOD FAITH EFFORT (GFE) WAS PERFORMED AND THE NURSE PRACTITIONER (NP) REPORTED THAT A SMALL PERICARDIAL EFFUSION WAS NOTED ON (B)(6) 2020 FOLLOWING THE IMPLANT PROCEDURE. THE PATIENT HAD A REPEAT ECHOCARDIOGRAM ON (B)(6) 2020, AND IT WAS CONFIRMED THE EFFUSION WAS STABLE. ON (B)(6) 2020, THE PATIENT EXPERIENCED SHORTNESS OF BREATH, AND ON (B)(6) 2020, THE PATIENT UNDERWENT PERICARDIOCENTESIS AND 500ML OF FLUID WERE REMOVED AFTER A PREVIOUSLY STABLE PERICARDIAL EFFUSION (PE) PROGRESSED TO BORDERLINE CARDIAC TAMPONADE. THE DRAIN WAS REMOVED ON (B)(6) 2020, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2020. THE PATIENT HAD A FOLLOW UP ON (B)(6) 2020, AND THE PATIENT WAS NOTED TO BE IN GOOD HEALTH AND ORAL ANTICOAGULATION (OAC) THERAPY WAS RESUMED. THE PATIEN

  Patient problems: Cardiac Tamponade; Dyspnea; Pericardial Effusion

  MAUDE report 22815137 ↗
• DeathMay 1, 2024Difficult to Open or Close; Difficult to Open or Close

  PER LITERATURE, IT WAS REPORTED THAT: THE PATIENT HAD A CHADSVASC SCORE OF 5 AND A HAS-BLED SCORE OF 3. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED TO TREAT PAROXYSMAL NON-VALVULAR ATRIAL FIBRILLATION. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AT THE LAA AND A 21MM WATCHMAN CLOSURE DEVICE AND DELIVERY SYSTEM (WDS) WERE ADVANCED. THE WDS WAS DEPLOYED AND IMPLANTED WITHOUT COMPLICATIONS. ONE (1) MONTH POST INDEX PROCEDURE, THE PATIENT PRESENTED WITH PRESYNCOPE. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING REVEALED AN ECHO DENSITY IN THE AORTIC VALVE, POSTERIOR LEAFLET OF THE MITRAL VALVE AND A POSSIBLE ECHO DENSITY ON THE CLOSURE DEVICE. CORONARY COMPUTED TOMOGRAPHY ANGIOGRAPHY (CCTA) DEMONSTRATED A SMALL CRESCENTIC LEAK ALONG THE IEFT POSTERIOR ASPECT OF THE CLOSURE DEVICE. BLOOD CULTURES WERE TAKEN AND GREW STAPHYLOCOCCUS EPIDERMIDIS. IN THE PHYSICIAN'S OPINION, THE CLOSURE DEVICE WAS THOUGHT TO BE THE SOURCE OF THE ENDOCARDITIS AS POST IMPLANTATION IMAGING DID NOT SHOW ANY ECHO DENSITIES ON THE CLOSURE DEVICE OR THE VALVES. THE PATIENT WAS DEEMED A POOR SURGICAL CANDIDATE BY THE CARDIOTHORACIC SURGERY FOR CLOSURE DEVICE REMOVAL AND THE DECISION WAS MADE

  Patient problems: Endocarditis; Presyncope

  MAUDE report 19219946 ↗
• InjuryDec 8, 2022Adverse 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. PRIOR TO THE INDEX PROCEDURE, ASPIRIN WAS ADMINISTERED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 21MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED WITH 1MM LARGEST RESIDUAL JET SIZE AROUND DEVICE AND DEPLOYED DEVICE DIAMETER OF 18 MM. AFTER THE IMPLANT THE PATIENT WAS STARTED ON CLOPIDOGREL. ASPIRIN WAS CONTINUED. ON (B)(6) 2020, THE PATIENT WAS DISCHARGED. ON (B)(6) 2022, 1058 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH SLURRED SPEECH AND RIGHT ARM NUMBNESS. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT. A HEAD COMPUTED TOMOGRAPHY (CT) WAS PERFORMED AND SHOWED NO ACUTE FINDINGS. ELECTROCARDIOGRAM AND LABORATORY TEST (BLOOD WORK) WERE ALSO PERFORMED AS DIAGNOSTICS. NEUROLOGY WAS CONSULTED AND THE PATIENT WAS DIAGNOSED WITH TRANSIENT ISCHEMIC ATTACKS (TIA), POSSIBLY SECONDARY TO MICROVASCULAR ISCHEMIA. NO CORRECTIVE ACTION WAS TAKEN TO TREAT THE EVENT. ON (B)(6) 2022, THE EVENT WAS CONSIDERED AS RESOLVED AND ON THE SAME DAY, THE PATIENT WAS DISCHARGED.

  Patient problems: Transient Ischemic Attack

  MAUDE report 15940969 ↗
• InjuryNov 23, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT AN ISCHEMIC CEREBRAL VASCULAR ACCIDENT (CVA) OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 21MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. TRANSESOPHAGEAL ECHO (TEE) WAS THE IMAGING MODALITY, AND NO LEAK WAS NOTED POST IMPLANT. THE PATIENT RETURNED FOR THEIR ROUTINE 45-DAY FOLLOW-UP ON (B)(6) 2019, AND NO LEAK WAS NOTED ON TEE AT THAT TIME. THE PATIENT THEN PRESENTED WITH STROKE SYMPTOMS ON (B)(6) 2022. THE PATIENT HAD A TEE ON (B)(6) 2022 WHICH SHOWED A SMALL LEAK, LESS THAN 2MM, AROUND THE DEVICE. A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WAS RECOMMENDED TO FURTHER ASSESS THE LEAK. THE CTA WAS COMPLETED ON (B)(6) 2022, AND A SMALL LEAK WAS AGAIN VISUALIZED, WHICH ALSO APPEARED TO OPEN UP INTO A LARGER UNCOVERED LOBE. THE PATIENT RESUMED AN ANTICOAGULATION REGIMENT AND MADE A FULL RECOVERY.

  Patient problems: Stroke/CVA

  MAUDE report 15855119 ↗
• InjuryMay 9, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE CLOSURE DEVICE DID NOT SEAL. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 21MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. THREE HUNDRED EIGHTY THREE (383) DAYS POST INDEX PROCEDURE, THE FOLLOW UP CARDIAC COMPUTED TOMOGRAPHY (CT) SCAN SHOWED A SMALL UNCOVERED LOBE ADJACENT TO THE CLOSURE DEVICE ON THE LEFT THAT WAS NOT SEEN ON THE 6 WEEK TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). THE LEAK WAS 9 X 5 MM AT THE OSTIUM AND 8MM AT DEPTH. THE PATIENT WAS ON 81MG OF ASPIRIN AT THE TIME OF THE EVENT. THE PLAN IS TO PLUG THE CLOSURE DEVICE IN RESPONSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14338582 ↗
• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS ENROLLED IN THE (B)(6) STUDY ON (B)(6) 2019 WITH PATIENT IDENTIFIER RD (B)(6). IT WAS REPORTED THAT A TRANSIENT ISCHEMIC ATTACK (TIA) OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. THE PATIENT UNDERWENT SUCCESSFUL PLACEMENT OF A 21 MM WATCHMAN LAA CLOSURE DEVICE WITH 1 MM JET SIZE AND DEPLOYED DEVICE DIAMETER OF 18 MM. PRIOR TO THE PROCEDURE ASPIRIN WAS ADMINISTERED. AFTER THE PROCEDURE, THE PATIENT WAS STARTED ON CLOPIDOGREL AND ASPIRIN WAS CONTINUED. THE PATIENT WAS DISCHARGED THE NEXT DAY. 717 DAYS POST-WATCHMAN IMPLANT PROCEDURE, THE PATIENT EXPERIENCED A SIXTY MINUTE EPISODE OF CONFUSION WITH VISUAL CHANGES, WHICH THE PATIENT ATTRIBUTED TO MIGRAINE SYMPTOMS. MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED AND THE PATIENT WAS DIAGNOSED WITH TIA AND WAS EVALUATED BY A NEUROLOGIST. NO INTERVENTION TOOK PLACE. THE SUSPECTED CAUSE OF THE TIA WAS UNKNOWN. ON THE SAME DAY THE EVENT WAS CONSIDERED TO BE RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Transient Ischemic Attack

  MAUDE report 13386297 ↗
• InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A DEVICE RELATED THROMBUS (DRT) OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 21MM WATCHMAN LAA CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED WITH NO LEAKS. THE PATIENT HAD A 45 DAY FOLLOW UP TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WITH NO DRT OR LEAK NOTED, SO THEY WERE TAKEN OFF THEIR ORAL ANTICOAGULANT (OAC) MEDICATION. THE PATIENT WAS TOLD TO TAKE PLAVIX AND ASPIRIN. AT THE SIX MONTH POST-OPERATIVE VISIT, THE PATIENT WAS TOLD TO STOP PLAVIX. THE PATIENT STATED THAT SHE DISCONTINUED ALL MEDICATION AFTER THE 45 DAY FOLLOW UP TEE. ABOUT 13 MONTHS POST PROCEDURE, THE PATIENT CAME BACK FOR A ROUTINE TEE WHICH REVEALED A THROMBUS ON TOP OF THE CLOSURE DEVICE TOWARD THE LIMBUS. THE PATIENT WAS PUT ON ELIQUIS AND WILL BE BROUGHT BACK IN SIX WEEKS FOR ANOTHER TEE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13017790 ↗
• InjuryJun 18, 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 PERFORMED. A 21MM WATCHMAN LAA CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED. IT WAS NOTED THERE WAS A SMALL EFFUSION OBSERVED PRIOR TO THE START OF THE PROCEDURE WITH NO CHANGE INTRAPROCEDURAL OR IMMEDIATELY POST PROCEDURE. TRANSTHORACIC ECHOCARDIOGRAPHY (TTE) WAS PERFORMED AN HOUR POST PROCEDURE DUE TO THE PATIENT COMPLAINT OF CHEST PAIN, BUT NO CHANGE IN THE EFFUSION WAS NOTED AT THAT TIME. SEVERAL HOURS POST PROCEDURE, THE EFFUSION GREW AND AN OPEN HEART PERICARDIAL WINDOW WAS PERFORMED TO TREAT THE EFFUSION. SIX DAYS POST PROCEDURE, THE PATIENT WAS DISCHARGED HOME. IT WAS FURTHER REPORTED THAT DURING THE PERICARDIAL TAP, THE RIGHT VENTRICLE WAS RUPTURED. THE RIGHT VENTRICLE WAS TREATED WITH OPEN HEART SURGERY TO CLOSE THE PUNCTURE SITE. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT POST REPAIR, AND DISCHARGED TO HOME.

  Patient problems: Chest Pain; Pericardial Effusion

  MAUDE report 12025374 ↗
• InjuryJun 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERFORATION, PERICARDIAL EFFUSION, AND HYPOTENSION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. AFTER TRANSSEPTAL PUNCTURE, AN ANTERIOR CURVE WATCHMAN ACCESS SYSTEM (WAS) WAS INTRODUCED TO THE LAA WITH A PIGTAIL CATHETER, AND HEPARIN WAS GIVEN POST TRANSSEPTAL PUNCTURE. THE ANTERIOR CURVE WAS HAD DIFFICULTY TRACKING OVER THE PIGTAIL WIRE INTO THE ANTERIOR LOBE OF THE LAA, AND AFTER 10-15 MINUTES, THE ANTERIOR CURVE WAS REMOVED FROM THE PATIENT. A SINGLE CURVE WATCHMAN ACCESS SYSTEM (WAS) WAS THEN POSITIONED AND A 21MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE RELEASE CRITERIA WERE MET AND THE CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED. THERE WAS NO PERICARDIAL EFFUSION NOTED POST DEVICE RELEASE. HEMOSTASIS WAS THEN ACHIEVED WITH A NON-BOSTON SCIENTIFIC VASCULAR CLOSURE DEVICE AND LIGHT PRESSURE POST HEPARIN REVERSAL. THE PATIENT'S BLOOD PRESSURE THEN DROPPED AND THE PATIENT BECAME UNSTABLE 30 MINUTES POST PROCEDURE. A PERICARDIAL EFFUSION WAS NOTED VIA INTRACARDIAC ECHOCARDIOGRAPHY (ICE), WHICH WAS CAUSED BY A CARDIAC PERFORATION. PERICARDIOCENTESIS WAS PERFORMED, AND 300 ML OF BLOOD WAS REMOVED FROM A

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

  MAUDE report 12001458 ↗
• InjuryMay 18, 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 21MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE CLOSURE DEVICE WAS PUSHED FORWARD DURING DEPLOYMENT, WHICH CAUSED A PERICARDIAL EFFUSION IN THE ANTERIOR LOBE OF THE LAA. THE CLOSURE DEVICE WAS RECAPTURED, RE-DEPLOYED AND SUCCESSFULLY IMPLANTED. PERICARDIOCENTESIS WAS PERFORMED TO TREAT THE PERICARDIAL EFFUSION WITH 650 ML OF BLOOD WITHDRAWN FROM THE EFFUSION SITE. THE DRAINAGE CATHETER WAS LEFT IN THE PATIENT OVERNIGHT. THE PATIENT WAS DISCHARGED ONE DAY POST PROCEDURE IN STABLE CONDITION.

  Patient problems: Pericardial Effusion

  MAUDE report 11843544 ↗
• InjuryMay 14, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT A LEAK OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 21MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. AT IMPLANT THERE WAS NO LEAK AND AT THE PATIENT'S 45-DAY FOLLOW-UP, THERE WAS A 3-4MM LEAK SHOWN. THE PATIENT HAD BEEN DOING WELL AND WHEN SHE WENT INTO ATRIAL FIBRILLATION, THE PHYSICIAN WANTED TO CARDIOVERT, SO A TRANSESOPHAGEAL ECHO (TEE) WAS OBTAINED AND A LARGE 9MM LEAK WAS NOTED. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED AND SHOWED A 7MM LEAK. THE PHYSICIAN IS PLANNING TO CLOSE THE LEAK IN THE NEXT COUPLE OF MONTHS. THE PATIENT IS DOING WELL AND HAS HAD NO ISSUES AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11827082 ↗
• InjuryApr 14, 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 TRUSEAL ACCESS SYSTEM (WAS) WAS POSITIONED AND A 21MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE WAS WAS POSITIONED IN THE LAA. THE WAS WAS DEEP SEATED, BUT WELL BUFFERED BY THE PIGTAIL, AND THE SHEATH REMAINED IN THE SAME POSITION UPON REMOVAL OF THE PIGTAIL CATHETER. WHEN THE CLOSURE DEVICE WAS DEPLOYED, IT APPEARED THE FEET OF THE DEVICE JUMPED FORWARD AS THE SHOULDERS WERE UNSHEATHED. ANGIOGRAPHY REVEALED A PERFORATION/PERICARDIAL EFFUSION NOTED DISTAL TO THE FEET OF THE DEVICE BY CONTRAST LEAKING INTO THE PERICARDIUM IN THE AREA OF THE TRANSVERSE SINUS AND POSTERIOR CAVITY. PROTAMINE WAS IMMEDIATELY ADMINISTERED TO REVERSE HEPARIN. THE DEVICE WAS RELEASED IN THE LAA AFTER ALL RELEASE CRITERIA WAS NOTED TO BE MET. A PERICARDIOCENTESIS WAS ATTEMPTED TO TREAT THE PERICARDIAL EFFUSION, HOWEVER, A FLUID RETURN COULD NOT BE SEEN AS THERE WAS SUCH A MINIMAL EFFUSION. THE EFFUSION WAS MONITORED WITH TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) FOR 30 MINUTES POST PROCEDURE AND NEVER INCREASED IN SIZE. THE PATIENT WAS

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 11665711 ↗
• InjuryMar 26, 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 OCCURRED. ON (B)(6) 2018, A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 21MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 17.5MM. AFTER THE IMPLANT THE PATIENT WAS STARTED ON BOTH ASPIRIN AND CLOPIDOGREL. THE PATIENT WAS DISCHARGED ON (B)(6) 2018. ON (B)(6) 2020, THE PATIENT EXPERIENCED DOUBLE VISION, DIFFICULTY IN FINDING WORDS, APPEARED TO BE CONFUSED AND WAS UNABLE TO AMBULATE NORMALLY. THE PATIENT WAS GIVEN 325MG OF ASPIRIN AND WAS BROUGHT TO THE EMERGENCY ROOM (ER) CONCERNING FOR ACUTE ISCHEMIC STROKE. A COMPUTED TOMOGRAPHY (CT) SCAN OF THE HEAD WAS PERFORMED ON THE SAME DAY, AND REVEALED NO ACUTE INTRACRANIAL ABNORMALITY AND STABLE MILD DIFFUSE ATROPHY OR VENTRICULOMEGALY. CTA HEAD AND NECK AND CEREBRAL PERFUSION REVEALED PARTIALLY CALCIFIED PLAQUE IN THE RIGHT CERATIOID BULB AND PROXIMAL INTERNAL CAROTID ARTERY (ICA) RESULTING IN APPROXIMATELY 60 PERCENT LUMINAL STENOSIS. MILD PARTIALLY CALCIFIED PLAQUE IN THE LEFT CAROTID BULB/ PROXIMAL ICA WITHOUT SIGNIFICANT LUMINAL NARROWING. PARTIALLY CALCIFIED PROXIMAL PLAQUE CAUSING MILD STENOSIS

  Patient problems: Transient Ischemic Attack

  MAUDE report 11575497 ↗
• InjuryMar 12, 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. AN ANTERIOR CURVE WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A 21MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. AFTER A FULL RECAPTURE OF THE DEVICE, A SHEATH EXCHANGE WAS NEEDED SINCE THERE WAS A KINK NOTED IN THE WAS AT THE GROIN. THE SHEATH WAS INSERTED THROUGH A 16FR NON-BOSTON SCIENTIFIC SHORT SHEATH. THE GUIDEWIRE USED TO SAVE THE TRANSSEPTAL ACCESS AND TO BE ABLE TO GO UP WITH A NEW WAS WAS AN 0.035 INCH NON-BOSTON SCIENTIFIC GUIDEWIRE. A PERICARDIAL EFFUSION WAS NOTED AT THIS TIME. THERE WAS A LOT OF MOVEMENT WITH THE GUIDEWIRE TO TRY AND REPOSITION BACK IN THE LEFT UPPER PULMONARY VEIN. THE PATIENT WAS STABLE AND THE CASE CONTINUED. A 24MM DEVICE WAS SUCCESSFULLY IMPLANTED AND THE PATIENT WAS KEPT ON THE CATH LAB TABLE TO WATCH THE EFFUSION AND MAKE SURE VITALS WERE STABLE. AS SOON AS THE 24MM WAS RELEASED, PROTAMINE WAS GIVEN TO REVERSE THE HEPARIN. ACTIVATED CLOTTING TIME (ACT) DURING THE CASE WAS 332 SECONDS. AFTER 15 MINUTES THE EFFUSION WAS MEASURED AGAIN AND IT WAS UNCHANGED AT 1.2CM. NO FURTHER INTERVENTION WAS REQUIRED. THE P

  Patient problems: Inflammation; Pericardial Effusion

  MAUDE report 11475585 ↗
• InjuryFeb 19, 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 21MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. AFTER THE PROCEDURE, A LATE ONSET PERICARDIAL EFFUSION WAS NOTED. A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS DOING WELL AND WAS DISCHARGED THE FOLLOWING DAY.

  Patient problems: Pericardial Effusion

  MAUDE report 11351616 ↗
• InjuryFeb 3, 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. NO EFFUSION WAS NOTED PRE-PROCEDURE. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A 21MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE DEVICE WAS DEPLOYED AND DID NOT REQUIRE ANY PARTIAL OR FULL RECAPTURES. POST-IMPLANT, A PERICARDIAL EFFUSION WAS NOTED WHICH REQUIRED A PERICARDIOCENTESIS AND DRAIN PLACEMENT. THE PATIENT REMAINED STABLE AND WAS DISCHARGED. THE DRAIN HAS BEEN REMOVED.

  Patient problems: Pericardial Effusion

  MAUDE report 11274586 ↗
• InjuryFeb 3, 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 21MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE DEVICE WAS DEPLOYED AND ONE PARTIAL RECAPTURE WAS REQUIRED. THE DEVICE MET RELEASE CRITERIA AND WAS RELEASED. POST-CASE TRANSESOPHAGEAL ECHO (TEE) SWEEPS DID NOT SHOW ANY EFFUSION. TWO HOURS POST-IMPLANT, A PERICARDIAL EFFUSION WAS NOTED. THE PATIENT WENT TO THE OPERATING ROOM AND HAD A STITCH PLACED AT THE DESCENDING END OF THE LAA. THERE WAS A SMALL TEAR FROM THE FEET OF THE WATCHMAN DEVICE. THE PATIENT IS REPORTED TO BE DOING WELL.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 11274559 ↗
• DeathJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA SOCIAL MEDIA THAT DEATH OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 21MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. NINE DAYS POST-PROCEDURE, THE PATIENT HAD A HEART ATTACK AND DIED.

  Patient problems: Death; Myocardial Infarction

  MAUDE report 11130914 ↗
• InjuryJan 4, 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. THE LAA WAS AN ANTERIOR CHICKEN WING. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A 21MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE WAS WAS PLACED WITHIN THE LAA WITH USE OF A PIGTAIL CATHETER. THE 21MM DEVICE WAS PREPPED AND THE PIGTAIL CATHETER WAS REMOVED. THE WDS WAS INSERTED INTO THE WAS AND ADVANCED TO THE DISTAL MARKER BAND. THE PHYSICIAN SNAPPED BACK LEFT TO RIGHT TO CONNECT THE WAS TO THE WDS. A PUFF OF CONTRAST SHOWED THAT THE WDS WAS IN THE PERICARDIUM. THE PHYSICIAN PULLED THE WHOLE SYSTEM BACK WITHIN THE LAA (CONFIRMED WITH CONTRAST) AND DEPLOYED THE 21MM WATCHMAN DEVICE. INITIALLY, THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED THE DEVICE TO BE POSITIONED WELL SO A TUG TEST WAS PERFORMED. DURING THIS TIME THE PATIENT WAS STABLE. THE TEE PRIOR TO ACCESS SHOWED A SMALL EFFUSION. THE DEVICE WAS ASSESSED BY ECHOCARDIOGRAM AND MET RELEASE CRITERIA AND WAS RELEASED. THE ACTIVATED CLOTTING TIME (ACT) WAS 340 AND PROTAMINE WAS GIVEN. THE WHOLE SYSTEM WAS PULLED OUT OF THE BODY AND THE GROIN SITE WAS CLOSED VIA TWO NON-BOSTON

  Patient problems: Pericardial Effusion

  MAUDE report 11110174 ↗
• InjuryDec 7, 2020Adverse 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 21MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. POST IMPLANT, LATER THAT EVENING, THERE WAS AN EFFUSION NOTED AROUND THE HEART, IN THE PERICARDIUM. A PERICARDIOCENTESIS WAS PERFORMED AND CARDIOVASCULAR SURGERY WAS CONTACTED. 2,000 CC OF BLOOD WAS WITHDRAWN AND AUTO-TRANSFUSED THROUGH A 16F SHEATH IN THE PATIENT'S RIGHT FEMORAL VEIN. AFTER THE SURGERY TEAM ARRIVED, IT WAS NOTED THAT THERE WAS THROMBUS AROUND THE HEART. AS THE PATIENT WAS ON PRESSORS, AND ALSO HAD CHRONIC OBSTRUCTIVE PULMONARY DISEASE, IT WAS DETERMINED THAT THE SAFEST COURSE OF ACTION WOULD BE TO SEND THE PATIENT FOR CARDIOVASCULAR SURGERY WHERE A SUTURE COULD BE UTILIZED TO CLOSE THE AREA THAT WAS BLEEDING. ON (B)(6) 2020, THE PATIENT WAS DOING WELL. IT WAS FURTHER REPORTED THAT THERE WAS A PERFORATION IN THE DISTAL ASPECT OF THE APPENDAGE. THE PERICARDIAL EFFUSION WAS DISCOVERED UPON RELEASE OF THE DEVICE AND WAS NOTED TO BE GROWING. A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS SENT TO SURGERY WHERE THE SMALL PERFORATION WAS REPAIRED IN THE LAA. THE PATIENT DID WELL AND WAS DISCHARGED 3

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 10960335 ↗
• InjuryNov 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CEREBRAL VASCULAR ACCIDENT. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A 21MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE CLOSURE DEVICE WAS IMPLANTED IN THE LAA OF THE PATIENT. THERE WERE NO COMPLICATIONS THAT WERE REPORTED TO HAVE OCCURRED. POST PROCEDURE THE PATIENT WAS NOTED TO HAVE LEFT SIDED FACIAL DROOP. THE PATIENT HAD A CT SCAN OF THEIR HEAD THAT SHOWED CEREBRAL ATROPHY AND MICROVASCULAR ISCHEMIC CHANGE. A FEW DAYS AFTER THIS THE PATIENT HAD A MAGNETIC RESONANCE IMAGING PROCEDURE PERFORMED. IT WAS NOTED THAT THE PATIENT HAD ACUTE VERY MILD LEFT FACIAL DROOP AND A POSSIBLE SMALL ISCHEMIC EVENT. THE PATIENT IS STILL EXPERIENCING MILD LEFT FACIAL DROOP AND MILD LEFT SIDE WEAKNESS.

  Patient problems: Stroke/CVA

  MAUDE report 10886802 ↗
• InjuryNov 6, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DEVICE EMBOLIZATION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 21MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. AT THE 45 DAY FOLLOW UP, THE CLOSURE DEVICE WAS FOUND IN THE AORTA. THERE WERE NO SYMPTOMS LEADING UP TO THE FOLLOW UP. A FEMORAL CUT DOWN WAS PERFORMED AND THE CLOSURE DEVICE WAS SNARED OUT THROUGH A LARGE 18-20FR SHEATH. THE PATIENT DID NOT HAVE ANY FURTHER ADVERSE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10801369 ↗
• InjuryOct 29, 2020Adverse 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 21MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE CLOSURE DEVICE WAS DEPLOYED IN A DISTAL POSITION. WHILE THE PHYSICIAN WAS ATTEMPTING A PARTIAL RECAPTURE THEY LOST CONTROL OF THE SYSTEM WHICH CAUSED IT TO ADVANCE FORWARD SIGNIFICANTLY IN THE LAA. THE SYSTEM WAS RETRACTED AND THE DEVICE WAS REDEPLOYED IN THE PATIENT WHILE AN EFFUSION CHECK WAS BEING PERFORMED. AT THIS TIME THE PATIENTS BLOOD PRESSURE BEGAN TO DROP, AND THE PHYSICIAN NOTED THAT THERE WAS A PERICARDIAL EFFUSION. THE PHYSICIAN PERFORMED A PERICARDIOCENTESIS WHERE AROUND 400CC OF BLOOD WAS ASPIRATED FROM THE PERICARDIAL SPACE AND THEN REINFUSED BACK INTO THE PATIENT. THE PATIENT ALSO RECEIVED A BLOOD TRANSFUSION TO HELP WITH THE EFFUSION AS WELL. THE PATIENT REMAINED STABLE AND ALSO RECEIVED PROTAMINE. THE EFFUSION WAS STABLE, BUT THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR FURTHER EXAMINATION. WHILE IN THE OR THE PATIENTS CHEST WAS OPENED AND IT WAS NOTED THAT THE FEET OF THE DEVICE WERE POKING OUT OF A

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

  MAUDE report 10757160 ↗
• DeathOct 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STROKE AND DEATH OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 21MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WAS IMPLANTED. LATER THAT EVENING, APPROXIMATELY FOUR HOURS POST IMPLANT, STROKE OCCURRED. A NEUROLOGICAL EVALUATION REVEALED A BRAIN SHIFT. THE PATIENT HAD SYMPTOMS OF NAUSEA AND CONFUSION. ALTHOUGH THE STROKE WAS HEMORRHAGIC AND UNLIKELY RELATED TO THE DEVICE, IT MAY BE RELATED TO THE PROCEDURE. THE PATIENT WAS MAINTAINED ON HEPARIN AT 300 RANGE. CT AND MRI WERE PERFORMED. NEURO SURGERY WAS OFFERED TO THE PATIENT BUT WAS DECLINED. THE PATIENT WAS SENT TO HOSPICE AND PASSED SEVERAL DAYS LATER.

  Patient problems: Death; Stroke/CVA

  MAUDE report 10750327 ↗
• InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PERICARDIAL EFFUSION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A 21MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WAS USED. THE CLOSURE DEVICE WAS DEPLOYED, BUT WAS TOO DISTAL, SO A PARTIAL RECAPTURE WAS PERFORMED AND NO PERICARDIAL EFFUSION WAS NOTED. THE CLOSURE DEVICE WAS DEPLOYED A SECOND TIME, BUT FAILED THE TUG TEST. IT WAS THEN FULLY RECAPTURED AND REMOVED FROM THE PATIENT. THERE WAS NO EFFUSION NOTED. A NON-BSC PIGTAIL CATHETER WAS REINSERTED INTO THE LAA AND AN EFFUSION WAS NOTICED. PERICARDIOCENTESIS WAS PERFORMED AND 700CC BLOOD WAS REMOVED AND GIVEN BACK TO THE PATIENT. ONCE THE EFFUSION AND PATIENT STABILIZED, THE PROCEDURE CONTINUED AND A 24MM WATCHMAN LAA CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS GIVEN PROTAMINE AND THE DRAIN WAS LEFT IN PLACE. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. THE DRAIN WAS REMOVED TWO DAYS POST PROCEDURE AND THE PATIENT WENT TO A STEP DOWN UNIT IN STABLE CONDITION. THE PHYSICIAN BELIEVES THE PERFORATION OCCURRED ON THE FULL RECAPTURE AND WAS NOT NOTICED UNTIL THE PIGTAIL WAS RE-INSERTED.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 10727824 ↗

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-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,
• 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