WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM
Report
- Report Number
- 2134265-2018-02045
- Event Type
- Injury
- Date Received
- March 9, 2018
- Date of Event
- February 15, 2018
- Report Date
- November 22, 2021
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NGV
- UDI-DI
- 08714729838241
- PMA / PMN Number
- P130013
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RETURNED FOR LAB ANALYSIS IMMEDIATELY. BOSTON SCIENTIFIC WAS NOTIFIED ON (B)(6) 2018 THAT THE CORE WIRE AND EMBOLIZED 27MM DEVICE WERE BEING RETAINED BY RISK MANAGEMENT AT THE HOSPITAL AND WOULD NOT BE RETURNED FOR ANALYSIS. THE HOSPITAL WAS IN POSSESSION OF THE DEVICE FOR AN EXCESS OF 3 YEARS. THE DEVICE WAS RECEIVED BY BOSTON SCIENTIFIC FOR ANALYSIS ON 22OCT2021. THE RETURNED PRODUCT CONSISTED OF A 27MM WATCHMAN DELIVERY SYSTEM WITH THE IMPLANT LOCATED OUTSIDE OF THE SHEATH AND DETACHED FROM THE CORE WIRE. THE DEVICE WAS BLOODY AND THERE WAS AN UNIDENTIFIED BLUE MATERIAL (UNRELATED TO THE WATCHMAN PRODUCT) WEAVED THROUGH THE IMPLANT FABRIC. THE BLUE MATERIAL WAS REMOVED DURING LAB ANALYSIS. ANALYSIS OF THE IMPLANT, CORE WIRE, TIP, SHEATH, AND HUB/VALVE INCLUDED VISUAL AND MICROSCOPIC INSPECTION. INSPECTION REVEALED DAMAGE (HOLES AND STRETCHED FABRIC) TO THE IMPLANT FABRIC, A SLIGHT BEND IN THE CORE WIRE LOCATED 24MM FROM THE CORE WIRE TIP WITH A SLIGHT FLATTING LOCATED APPROXIMATELY 63MM-65MM (FROM CORE WIRE TIP), AND NUMEROUS SMALL KINKS THROUGHOUT THE LENGTH OF THE SHEATH. INSPECTION OF THE REST OF THE DEVICE FOUND NO OTHER DAMAGE OR DEFECTS. DEVICE FUNCTIONALITY WAS CARRIED OUT BY RE-ATTACHING THE IMPLANT TO THE CORE WIRE. THE IMPLANT SCREWED ONTO THE CORE WIRE TIP EASILY, AND WITHOUT RESISTANCE. THERE WERE NO TACTILE DIFFICULTIES THREADING OR UNTHREADING THE IMPLANT TO ITS LIMIT AND THE ACT OF THREADING AND UNTHREADING THE IMPLANT WAS SMOOTH THROUGHOUT THE THREAD MESH. TENSILE FORCE WAS APPLIED TO THE IMPLANT, AND THE THREADS PROVIDED SECURE ATTACHMENT BETWEEN THE CORE WIRE AND THE IMPLANT AS EVIDENCED THROUGH LOADS HIGH ENOUGH TO ALTER THE SHAPE OF THE IMPLANT. THE IMPLANT RELEASED FROM THE CORE WIRE AFTER THREE FULL ROTATIONS. REVIEW OF THE REPORTING COMPLAINT INFORMATION NOTED THE SEAL WAS BROKE AND THE IMPLANT MOVED WITH THE MOVEMENT OF THE CORE WIRE, INDICATING THAT THE IMPLANT WAS ATTACHED TO THE CORE WIRE, AND WAS ALSO ATTACHED WHEN THE IMPLANT WAS MOVED WHEN ALIGNING TO THE MAKERBANDS. PER EXTERNAL REQUEST, ADDITIONAL MTAC TESTING WAS PERFORMED ON THE RETURNED DEVICE. THE MTAC SEM INVESTIGATION RESULTED IN NO ABNORMALITIES OR OBSERVATIONS ASSOCIATED TO MATERIALS OR DEVICE MALFUNCTION. MEDIA FROM THE CLINICAL PROCEDURE WAS PROVIDED TO BOSTON SCIENTIFIC AND REVIEWED BY A MEMBER OF THE BOSTON SCIENTIFIC GLOBAL MEDICAL SAFETY ORGANIZATION. THE MEDIA REVIEW REPORT CONCLUDED: "IN CONCLUSION, THE MEDIA REVIEW IS CONSISTENT WITH THE EVENT INFORMATION RECEIVED, SHOWING IMMEDIATE EMBOLIZATION OF THE SECOND WATCHMAN IMPLANT ONCE IT IS PUSHED OUT OF THE SHEATH. IN THE FLUOROSCOPY VIDEO LOOP SHOWING THE DEPLOYMENT, IT IS VISIBLE THAT THE IMPLANT HAS BECOME DETACHED FROM THE CORE WIRE. IT IS NOT CLEAR FROM THE MEDIA ALONE WHEN THIS DETACHMENT OCCURRED." THE REPORTED DEVICE DETACHMENT AND EMBOLIZATION WAS CONFIRMED VIA MEDIA REVIEW. THE REPORTED AIR IN SYSTEM, AND PATIENT DEATH COULD NOT BE CONFIRMED AS CLINICAL CIRCUMSTANCES COULD NOT BE REPLICATED.
IT WAS REPORTED THAT AN EMBOLIZATION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. THE PATIENTS ACTIVATED CLOTTING TIME (ACT) RANGE AFTER THE TRANSSEPTAL PUNCTURE WAS 241-357 AND A TRACE EFFUSION WAS NOTICED. THE LA PRESSURE WAS 13. A 30MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WAS SELECTED FOR USE. DURING PREPARATION, THE CLOSURE DEVICE WAS INADVERTENTLY DEPLOYED ON THE BACK TABLE BY THE TECHNICIAN. THIS DELIVERY SYSTEM WAS NOT USED. ANOTHER 30MM WDS WAS SELECTED. THIS WDS WAS PREPARED AND THEY WERE WATCHING FOR AIR. AIR WAS NOTICED IN THE WDS AS IT WAS BROUGHT TO THE STERILE TABLE. THEY REMOVED THE WDS FROM THE STERILE TABLE AND RE-PREPARED IT AGAIN LOOKING FOR AIR. AIR WAS NOT SEEN, SO IT WAS THEN USED IN THE PROCEDURE. THE WDS WAS ADVANCED INTO THE WATCHMAN ACCESS SYSTEM (WAS). THE CLOSURE DEVICE WAS DEPLOYED, BUT NOTED TO BE PROXIMAL SO A FULL RECAPTURE WAS PREFORMED AND THE WDS WAS REMOVED. AN EFFUSION SWEEP WAS PERFORMED AND SAW NO EFFUSION. A THIRD WDS WAS USED AND THIS TIME IT WAS A 27MM WDS. IT WAS PREPARED ON THE BACK TABLE AND THEY WERE LOOKING FOR AIR. THE SEAL OF THE CLOSURE DEVICE WAS BROKEN IN ORDER TO CORRECTLY PREPARE THE DEVICE. DURING PREPARATION OF THIS 27MM WDS, THE ECHO PHYSICIAN SAW A CLOT ON THE RIGHT SIDE OF THE HEART ON THE SEPTUM. THE WAS PULLED BACK ACROSS THE SEPTUM WHILE BEING ASPIRATED WITH A SYRINGE IN AN ATTEMPT TO REMOVE THE CLOT. ONCE THE SHEATH WAS REMOVED THE CLOT WAS NO LONGER SEEN ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND THE PATIENT REMAINED STABLE. AS THE WAS REMOVED, IT WAS NOTED THAT THERE WAS A KINK IN THE WAS NEAR THE 33MM MARKER BAND. THE WAS THEN EXCHANGED FOR A SECOND DOUBLE CURVE WAS (LOT 21470960). LAA POSITION WAS REGAINED, THE APPENDOGRAM WAS RETAKEN, AND THE 27MM DEVICE WAS PREPARED. THE FEET OF THE DEVICE WERE MOVED TO ENSURE THEY WERE POSITIONED AT THE DISTAL MARKER BAND OF THE DEPLOYMENT SYSTEM. NO AIR BUBBLES WERE NOTED IN THE WDS. THE WDS WAS ADVANCED INTO THE WAS. AS THE DISTAL MARKER BANDS WERE BEING ALIGNED, AN AIR BUBBLE WAS NOTED IN THE WDS. THE WDS WAS REMOVED AND RE-PREPPED AND THEY WERE AGAIN LOOKING FOR AIR. NO AIR BUBBLES WERE NOTED AND THE FEET OF THE DEVICE WERE ALIGNED WITH THE DISTAL MARKER BAND. THE FEET OF THE CLOSURE DEVICE WERE NOTED TO HAVE MOVED FORWARD PAST DISTAL MARKER BAND WHEN THE WDS WAS BROUGHT TO STERILE TABLE AND THE PHYSICIAN WAS PREPARING TO ADVANCE INTO THE BODY. AIR WAS INTRODUCED WHEN PULLING THE FEET BACK TO MARKER BAND ALIGNMENT, SO THE WDS WAS RE-PREPPED ON THE BACK TABLE. THE PROPERLY ALIGNED WDS WAS THEN INSERTED INTO THE WAS. THE WDS WAS THEN ADVANCED UNTIL THE DISTAL MARKER BANDS WERE ALIGNED AND THE WAS AND WDS WERE NOW SNAPPED AS A SYSTEM. THEY WERE DEEP SEATED IN THE LAA, SO THEY WANTED TO MAKE SURE THEY WATCH THE BACK WALL OF THE LAA UPON DEPLOYMENT. AS THE CLOSURE DEVICE WAS DEPLOYED, IT WAS NOTED THE FEET OF THE DEVICE WERE COMING BACK SLIGHTLY. ONCE THE DEVICE WAS DEPLOYED, IT IMMEDIATELY EMBOLIZED INTO THE LEFT ATRIUM. THE CORE WIRE AND THE DEVICE WERE NOT ATTACHED UPON DEPLOYMENT ALLOWING FOR THE DEVICE TO EMBOLIZE AND MOVE FREELY IN THE LEFT ATRIUM. THE WDS WAS REMOVED AND THE WAS KEPT IN PLACE. THE DEVICE REMAINED IN THE LEFT ATRIUM. THE PATIENT REMAINED STABLE. PRADAXA WAS REVERSED WITH PRAXBIND. A 25MM NON-BSC GOOSE NECK SNARE WAS INSERTED INTO THE SHEATH IN AN ATTEMPT TO SNARE THE DEVICE. AT THE SAME TIME THE, OPERATING ROOM WAS CALLED AND MADE AWARE OF A POTENTIAL EMERGENT CASE. AS THE PHYSICIAN WAS ATTEMPTING TO SNARE THE DEVICE, THE DEVICE BECAME LODGED IN THE MITRAL VALVE ANNULUS WITH THE FABRIC FACING TOWARD THE ATRIUM. THE PATIENT BECAME HEMODYNAMICALLY COMPROMISED, DEVELOPING HYPOTENSION. THE TEE WAS MAINTAINED AND THE VIEW OF DEVICE WAS CONTINUOUS. NOREPINEPHRINE AND LEVOPHED WERE STARTED TO HELP MANAGE THE PATIENTS BLOOD PRESSURE. RIGHT FEMORAL ARTERIAL ACCESS WAS GAINED VIA A MODIFIED SELDINGER TECHNIQUE, AND A 7F SHEATH WAS PLACED. UNDER FLUOROSCOPIC GUIDANCE, AN INTRA-ARTERIAL BALLOON PUMP (IABP) WAS INSERTED TO ASSIST WITH HEMODYNAMIC INSTABILITY. AUGMENTATION WAS EXCELLENT AT A 1:1 RATIO. THE PATIENTS BLOOD PRESSURE IMPROVED MARKEDLY ONCE THE IABP WAS PLACED. THE OPERATING ROOM (OR) WAS NOTIFIED THAT THIS WAS AN EMERGENT PATIENT AND A ROOM WAS PREPARED. THE PATIENT REMAINED STABLE ON CARDIAC SUPPORT. THE CLOSURE DEVICE WAS NOTED TO HAVE MIGRATED TO LEFT VENTRICLE UPON ARRIVAL TO OR. A CARDIOVASCULAR SURGEON REMOVED THE CLOSURE DEVICE, LIGATED THE LAA, AND THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT. THERE WAS MILD TO MODERATE MITRAL REGURGITATION SEEN ON ECHOCARDIOGRAM AND THE PATIENT WAS BEING WEANED OFF PHARMACOLOGICAL SUPPORT. THE PATIENT WAS STABLE THAT EVENING AND WAS DISCHARGED THE FOLLOWING WEEK. IT WAS FURTHER REPORTED THAT ON 29 JULY 2018 THE PATIENT PASSED AWAY FROM INJURIES THAT WERE SUSTAINED FROM THESE EVENTS.
IT WAS REPORTED THAT AN EMBOLIZATION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. THE PATIENTS ACTIVATED CLOTTING TIME (ACT) RANGE AFTER THE TRANSSEPTAL PUNCTURE WAS 241-357 AND A TRACE EFFUSION WAS NOTICED. THE LA PRESSURE WAS 13. A 30MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WAS SELECTED FOR USE. DURING PREPARATION, THE CLOSURE DEVICE WAS INADVERTENTLY DEPLOYED ON THE BACK TABLE BY THE TECHNICIAN. THIS DELIVERY SYSTEM WAS NOT USED. ANOTHER 30MM WDS WAS SELECTED. THIS WDS WAS PREPARED AND THEY WERE WATCHING FOR AIR. AIR WAS NOTICED IN THE WDS AS IT WAS BROUGHT TO THE STERILE TABLE. THEY REMOVED THE WDS FROM THE STERILE TABLE AND RE-PREPARED IT AGAIN LOOKING FOR AIR. AIR WAS NOT SEEN, SO IT WAS THEN USED IN THE PROCEDURE. THE WDS WAS ADVANCED INTO THE WATCHMAN ACCESS SYSTEM (WAS). THE CLOSURE DEVICE WAS DEPLOYED, BUT NOTED TO BE PROXIMAL SO A FULL RECAPTURE WAS PREFORMED AND THE WDS WAS REMOVED. AN EFFUSION SWEEP WAS PERFORMED AND SAW NO EFFUSION. A THIRD WDS WAS USED AND THIS TIME IT WAS A 27MM WDS. IT WAS PREPARED ON THE BACK TABLE AND THEY WERE LOOKING FOR AIR. THE SEAL OF THE CLOSURE DEVICE WAS BROKEN IN ORDER TO CORRECTLY PREPARE THE DEVICE. DURING PREPARATION OF THIS 27MM WDS, THE ECHO PHYSICIAN SAW A CLOT ON THE RIGHT SIDE OF THE HEART ON THE SEPTUM. THE WAS PULLED BACK ACROSS THE SEPTUM WHILE BEING ASPIRATED WITH A SYRINGE IN AN ATTEMPT TO REMOVE THE CLOT. ONCE THE SHEATH WAS REMOVED THE CLOT WAS NO LONGER SEEN ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND THE PATIENT REMAINED STABLE. AS THE WAS REMOVED, IT WAS NOTED THAT THERE WAS A KINK IN THE WAS NEAR THE 33MM MARKER BAND. THE WAS THEN EXCHANGED FOR A SECOND DOUBLE CURVE WAS (LOT: 21470960). LAA POSITION WAS REGAINED, THE APPENDOGRAM WAS RETAKEN, AND THE 27MM DEVICE WAS PREPARED. THE FEET OF THE DEVICE WERE MOVED TO ENSURE THEY WERE POSITIONED AT THE DISTAL MARKER BAND OF THE DEPLOYMENT SYSTEM. NO AIR BUBBLES WERE NOTED IN THE WDS. THE WDS WAS ADVANCED INTO THE WAS. AS THE DISTAL MARKER BANDS WERE BEING ALIGNED, AN AIR BUBBLE WAS NOTED IN THE WDS. THE WDS WAS REMOVED AND RE-PREPPED AND THEY WERE AGAIN LOOKING FOR AIR. NO AIR BUBBLES WERE NOTED AND THE FEET OF THE DEVICE WERE ALIGNED WITH THE DISTAL MARKER BAND. THE FEET OF THE CLOSURE DEVICE WERE NOTED TO HAVE MOVED FORWARD PAST DISTAL MARKER BAND WHEN THE WDS WAS BROUGHT TO STERILE TABLE AND THE PHYSICIAN WAS PREPARING TO ADVANCE INTO THE BODY. AIR WAS INTRODUCED WHEN PULLING THE FEET BACK TO MARKER BAND ALIGNMENT, SO THE WDS WAS RE-PREPPED ON THE BACK TABLE. THE PROPERLY ALIGNED WDS WAS THEN INSERTED INTO THE WAS. THE WDS WAS THEN ADVANCED UNTIL THE DISTAL MARKER BANDS WERE ALIGNED AND THE WAS AND WDS WERE NOW SNAPPED AS A SYSTEM. THEY WERE DEEP SEATED IN THE LAA, SO THEY WANTED TO MAKE SURE THEY WATCH THE BACK WALL OF THE LAA UPON DEPLOYMENT. AS THE CLOSURE DEVICE WAS DEPLOYED, IT WAS NOTED THE FEET OF THE DEVICE WERE COMING BACK SLIGHTLY. ONCE THE DEVICE WAS DEPLOYED, IT IMMEDIATELY EMBOLIZED INTO THE LEFT ATRIUM. THE CORE WIRE AND THE DEVICE WERE NOT ATTACHED UPON DEPLOYMENT ALLOWING FOR THE DEVICE TO EMBOLIZE AND MOVE FREELY IN THE LEFT ATRIUM. THE WDS WAS REMOVED AND THE WAS KEPT IN PLACE. THE DEVICE REMAINED IN THE LEFT ATRIUM. THE PATIENT REMAINED STABLE. PRADAXA WAS REVERSED WITH PRAXBIND. A 25MM NON-BSC GOOSE NECK SNARE WAS INSERTED INTO THE SHEATH IN AN ATTEMPT TO SNARE THE DEVICE. AT THE SAME TIME THE, OPERATING ROOM WAS CALLED AND MADE AWARE OF A POTENTIAL EMERGENT CASE. AS THE PHYSICIAN WAS ATTEMPTING TO SNARE THE DEVICE, THE DEVICE BECAME LODGED IN THE MITRAL VALVE ANNULUS WITH THE FABRIC FACING TOWARD THE ATRIUM. THE PATIENT BECAME HEMODYNAMICALLY COMPROMISED, DEVELOPING HYPOTENSION. THE TEE WAS MAINTAINED AND THE VIEW OF DEVICE WAS CONTINUOUS. NOREPINEPHERINE AND LEVOPHED WERE STARTED TO HELP MANAGE THE PATIENTS BLOOD PRESSURE. RIGHT FEMORAL ARTERIAL ACCESS WAS GAINED VIA A MODIFIED SELDINGER TECHNIQUE, AND A 7F SHEATH WAS PLACED. UNDER FLUOROSCOPIC GUIDANCE, AN INTRA-ARTERIAL BALLOON PUMP (IABP) WAS INSERTED TO ASSIST WITH HEMODYNAMIC INSTABILITY. AUGMENTATION WAS EXCELLENT AT A 1:1 RATIO. THE PATIENTS BLOOD PRESSURE IMPROVED MARKEDLY ONCE THE IABP WAS PLACED. THE OPERATING ROOM (OR) WAS NOTIFIED THAT THIS WAS AN EMERGENT PATIENT AND A ROOM WAS PREPARED. THE PATIENT REMAINED STABLE ON CARDIAC SUPPORT. THE CLOSURE DEVICE WAS NOTED TO HAVE MIGRATED TO LEFT VENTRICLE UPON ARRIVAL TO OR. A CARDIOVASCULAR SURGEON REMOVED THE CLOSURE DEVICE, LIGATED THE LAA, AND THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT. THERE WAS MILD TO MODERATE MITRAL REGURGITATION SEEN ON ECHOCARDIOGRAM AND THE PATIENT WAS BEING WEANED OFF PHARMACOLOGICAL SUPPORT. THE PATIENT WAS STABLE THAT EVENING AND WAS DISCHARGED THE FOLLOWING WEEK. IT WAS FURTHER REPORTED THAT ON (B)(6) 2018 THE PATIENT PASSED AWAY FROM INJURIES THAT WERE SUSTAINED FROM THESE EVENTS. IT WAS FURTHER REPORTED THAT FOLLOWING REMOVAL OF THE DEVICE, THE PHYSICIAN NOTED MODERATE MITRAL REGURGITATION. A LEFT ATRIAL APPENDAGE LIGATION (SURGICAL CLOSURE OF THE LAA) AND A MODIFIED CRYOMAZE PROCEDURE (USE OF EXTREME COLD TO TREAT AREA OF HEART CAUSING AFIB) WAS PERFORMED. A TRANSESOPHAGEAL ECHO SHOWED NORMAL VENTRICULAR FUNCTION AND STABLE MODERATE MITRAL REGURGITATION POSTOPERATIVELY. THE PATIENT WAS ON CARDIOPULMONARY BYPASS FOR 77 MINUTES. IMMEDIATELY FOLLOWING SURGERY, THE PATIENT REMAINED STABLE ON A VENTILATOR WITH THE IABP, BUT WAS NOTED TO HAVE PULMONARY EDEMA FROM THE PRIOR SHOCK STATE. ON POST-OPERATIVE DAY 4, THE PATIENT WAS FOUND TO HAVE AFIB WITH RATES RANGING FROM 54 TO 66. A CHEST X-RAY SHOWED BILATERAL ATELECTASIS / PLEURAL EFFUSIONS (ACCUMULATION OF FLUID IN THE THIN MEMBRANE SURROUNDING THE LUNG). THE FOLLOWING DAY, THE AFIB WAS MORE RAPID WITH FREQUENT PAUSES. THE PATIENT EVENTUALLY DETERIORATED TO ASYSTOLE (CARDIAC ARREST RHYTHM WITH NO DISCERNABLE ELECTRICAL ACTIVITY) AFTER RECEIVING A BETA BLOCKER. THEREAFTER, SHE WAS TRANSFERRED TO THE ICU AND RHYTHM RESUSCITATED. ON (B)(6) 2018, THE PATIENT WAS TAKEN TO THE ELECTROPHYSIOLOGY LAB AND A DDD PACEMAKER WAS PLACED. A CHEST X-RAY CONTINUED TO DEMONSTRATE BILATERAL PLEURAL EFFUSIONS. ON (B)(6) 2018, THE PATIENT WAS DISCHARGED TO A SKILLED NURSING FACILITY. UNFORTUNATELY, HER CONDITION WORSENED, AND SHE WAS BROUGHT BACK TO THE HOSPITAL ON (B)(6) 2018, WITH A SYMPTOMATIC ATRIAL FLUTTER WITH A RAPID VENTRICULAR RESPONSE. SHE WAS ALSO FOUND TO BE IN DIASTOLIC HEART FAILURE REQUIRING DIURESIS. THE PATIENT ULTIMATELY UNDERWENT SUCCESSFUL DC CARDIOVERSION TO TREAT HER AFIB AND WAS DISCHARGED BACK TO THE SKILLED NURSING FACILITY ON (B)(6) 2018. FOLLOWING DISCHARGE, THE PATIENT CONTINUED TO STRUGGLE WITH FLUID ACCUMULATION AND RESPIRATORY DISTRESS ASSOCIATED WITH DIASTOLIC HEART FAILURE. ON (B)(6) 2018, SHE RETURNED TO (B)(6) HOSPITAL WITH INCREASING SHORTNESS OF BREATH. SHE WAS FOUND TO HAVE ACUTE HYPOXEMIC RESPIRATORY FAILURE, ACUTE CONGESTIVE HEART FAILURE, AND HEALTH CARE ASSOCIATED PNEUMONIA. SHE WAS ADMITTED TO THE HOSPITAL AND TREATED WITH BROAD-SPECTRUM ANTIBIOTICS FOR 7 DAYS FOR HER PNEUMONIA. SHE WAS ALSO SEEN BY CARDIOLOGY AND AGGRESSIVELY DIURESED. THE PATIENT WAS NOTED TO HAVE LARGE BILATERAL PLEURAL EFFUSIONS AND WAS SEEN IN CONSULTATION BY A PULMONOLOGIST. THORACENTESIS WAS INITIALLY PERFORMED ON THE RIGHT SIDE WITH DRAMATIC IMPROVEMENT IN HER OXYGEN DEMANDS. SHE ALSO HAD A THORACENTESIS ON THE LEFT SIDE PERFORMED TO FURTHER IMPROVE HER PULMONARY STATUS. THE PATIENT WAS DISCHARGED BACK TO THE SKILLED NURSING FACILITY ON (B)(6) 2018. FOLLOWING DISCHARGE, THE PATIENT CONTINUED TO STRUGGLE WITH SEVERE RESPIRATORY DISTRESS SECONDARY TO DIASTOLIC HEART FAILURE. ON (B)(6) 2018, THE PATIENT DIED FROM HYPOXEMIC RESPIRATORY FAILURE SECONDARY TO DIASTOLIC HEART FAILURE.
IT WAS REPORTED THAT AN EMBOLIZATION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. THE PATIENTS ACTIVATED CLOTTING TIME (ACT) RANGE AFTER THE TRANSSEPTAL PUNCTURE WAS 241-357 AND A TRACE EFFUSION WAS NOTICED. THE LA PRESSURE WAS 13. A 30MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WAS SELECTED FOR USE. DURING PREPARATION, THE CLOSURE DEVICE WAS INADVERTENTLY DEPLOYED ON THE BACK TABLE BY THE TECHNICIAN. THIS DELIVERY SYSTEM WAS NOT USED. ANOTHER 30MM WDS WAS SELECTED. THIS WDS WAS PREPARED AND THEY WERE WATCHING FOR AIR. AIR WAS NOTICED IN THE WDS AS IT WAS BROUGHT TO THE STERILE TABLE. THEY REMOVED THE WDS FROM THE STERILE TABLE AND RE-PREPARED IT AGAIN LOOKING FOR AIR. AIR WAS NOT SEEN, SO IT WAS THEN USED IN THE PROCEDURE. THE WDS WAS ADVANCED INTO THE WATCHMAN ACCESS SYSTEM (WAS). THE CLOSURE DEVICE WAS DEPLOYED, BUT NOTED TO BE PROXIMAL SO A FULL RECAPTURE WAS PREFORMED AND THE WDS WAS REMOVED. AN EFFUSION SWEEP WAS PERFORMED AND SAW NO EFFUSION. A THIRD WDS WAS USED AND THIS TIME IT WAS A 27MM WDS. IT WAS PREPARED ON THE BACK TABLE AND THEY WERE LOOKING FOR AIR. THE SEAL OF THE CLOSURE DEVICE WAS BROKEN IN ORDER TO CORRECTLY PREPARE THE DEVICE. DURING PREPARATION OF THIS 27MM WDS, THE ECHO PHYSICIAN SAW A CLOT ON THE RIGHT SIDE OF THE HEART ON THE SEPTUM. THE WAS WAS PULLED BACK ACROSS THE SEPTUM WHILE BEING ASPIRATED WITH A SYRINGE IN AN ATTEMPT TO REMOVE THE CLOT. ONCE THE SHEATH WAS REMOVED THE CLOT WAS NO LONGER SEEN ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND THE PATIENT REMAINED STABLE. AS THE WAS WAS REMOVED, IT WAS NOTED THAT THERE WAS A KINK IN THE WAS NEAR THE 33MM MARKER BAND. THE WAS WAS THEN EXCHANGED FOR A SECOND DOUBLE CURVE WAS (LOT 21470960). LAA POSITION WAS REGAINED, THE APPENDOGRAM WAS RETAKEN, AND THE 27MM DEVICE WAS PREPARED. THE FEET OF THE DEVICE WERE MOVED TO ENSURE THEY WERE POSITIONED AT THE DISTAL MARKER BAND OF THE DEPLOYMENT SYSTEM. NO AIR BUBBLES WERE NOTED IN THE WDS. THE WDS WAS ADVANCED INTO THE WAS. AS THE DISTAL MARKER BANDS WERE BEING ALIGNED, AN AIR BUBBLE WAS NOTED IN THE WDS. THE WDS WAS REMOVED AND RE-PREPPED AND THEY WERE AGAIN LOOKING FOR AIR. NO AIR BUBBLES WERE NOTED AND THE FEET OF THE DEVICE WERE ALIGNED WITH THE DISTAL MARKER BAND. THE FEET OF THE CLOSURE DEVICE WERE NOTED TO HAVE MOVED FORWARD PAST DISTAL MARKER BAND WHEN THE WDS WAS BROUGHT TO STERILE TABLE AND THE PHYSICIAN WAS PREPARING TO ADVANCE INTO THE BODY. AIR WAS INTRODUCED WHEN PULLING THE FEET BACK TO MARKER BAND ALIGNMENT, SO THE WDS WAS RE-PREPPED ON THE BACK TABLE. THE PROPERLY ALIGNED WDS WAS THEN INSERTED INTO THE WAS. THE WDS WAS THEN ADVANCED UNTIL THE DISTAL MARKER BANDS WERE ALIGNED AND THE WAS AND WDS WERE NOW SNAPPED AS A SYSTEM. THEY WERE DEEP SEATED IN THE LAA, SO THEY WANTED TO MAKE SURE THEY WATCH THE BACK WALL OF THE LAA UPON DEPLOYMENT. AS THE CLOSURE DEVICE WAS DEPLOYED, IT WAS NOTED THE FEET OF THE DEVICE WERE COMING BACK SLIGHTLY. ONCE THE DEVICE WAS DEPLOYED, IT IMMEDIATELY EMBOLIZED INTO THE LEFT ATRIUM. THE CORE WIRE AND THE DEVICE WERE NOT ATTACHED UPON DEPLOYMENT ALLOWING FOR THE DEVICE TO EMBOLIZE AND MOVE FREELY IN THE LEFT ATRIUM. THE WDS WAS REMOVED AND THE WAS WAS KEPT IN PLACE. THE DEVICE REMAINED IN THE LEFT ATRIUM. THE PATIENT REMAINED STABLE. PRADAXA WAS REVERSED WITH PRAXBIND. A 25MM NON-BSC GOOSE NECK SNARE WAS INSERTED INTO THE SHEATH IN AN ATTEMPT TO SNARE THE DEVICE. AT THE SAME TIME THE, OPERATING ROOM WAS CALLED AND MADE AWARE OF A POTENTIAL EMERGENT CASE. AS THE PHYSICIAN WAS ATTEMPTING TO SNARE THE DEVICE, THE DEVICE BECAME LODGED IN THE MITRAL VALVE ANNULUS WITH THE FABRIC FACING TOWARD THE ATRIUM. THE PATIENT BECAME HEMODYNAMICALLY COMPROMISED, DEVELOPING HYPOTENSION. THE TEE WAS MAINTAINED AND THE VIEW OF DEVICE WAS CONTINUOUS. NOREPINEPHERINE AND LEVOPHED WERE STARTED TO HELP MANAGE THE PATIENTS BLOOD PRESSURE. RIGHT FEMORAL ARTERIAL ACCESS WAS GAINED VIA A MODIFIED SELDINGER TECHNIQUE, AND A 7F SHEATH WAS PLACED. UNDER FLUOROSCOPIC GUIDANCE, AN INTRA-ARTERIAL BALLOON PUMP (IABP) WAS INSERTED TO ASSIST WITH HEMODYNAMIC INSTABILITY. AUGMENTATION WAS EXCELLENT AT A 1:1 RATIO. THE PATIENTS BLOOD PRESSURE IMPROVED MARKEDLY ONCE THE IABP WAS PLACED. THE OPERATING ROOM (OR) WAS NOTIFIED THAT THIS WAS AN EMERGENT PATIENT AND A ROOM WAS PREPARED. THE PATIENT REMAINED STABLE ON CARDIAC SUPPORT. THE CLOSURE DEVICE WAS NOTED TO HAVE MIGRATED TO LEFT VENTRICLE UPON ARRIVAL TO OR. A CARDIOVASCULAR SURGEON REMOVED THE CLOSURE DEVICE, LIGATED THE LAA, AND THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT. THERE WAS MILD TO MODERATE MITRAL REGURGITATION SEEN ON ECHOCARDIOGRAM AND THE PATIENT WAS BEING WEANED OFF PHARMACOLOGICAL SUPPORT. THE PATIENT WAS STABLE THAT EVENING AND WAS DISCHARGED THE FOLLOWING WEEK. IT WAS FURTHER REPORTED THAT ON (B)(6) 2018 THE PATIENT PASSED AWAY FROM INJURIES THAT WERE SUSTAINED FROM THESE EVENTS. IT WAS FURTHER REPORTED THAT FOLLOWING REMOVAL OF THE DEVICE, THE PHYSICIAN NOTED MODERATE MITRAL REGURGITATION. A LEFT ATRIAL APPENDAGE LIGATION (SURGICAL CLOSURE OF THE LAA) AND A MODIFIED CRYOMAZE PROCEDURE (USE OF EXTREME COLD TO TREAT AREA OF HEART CAUSING AFIB) WAS PERFORMED. A TRANSESOPHAGEAL ECHO SHOWED NORMAL VENTRICULAR FUNCTION AND STABLE MODERATE MITRAL REGURGITATION POSTOPERATIVELY. THE PATIENT WAS ON CARDIOPULMONARY BYPASS FOR 77 MINUTES. IMMEDIATELY FOLLOWING SURGERY, THE PATIENT REMAINED STABLE ON A VENTILATOR WITH THE IABP, BUT WAS NOTED TO HAVE PULMONARY EDEMA FROM THE PRIOR SHOCK STATE. ON POST-OPERATIVE DAY 4, THE PATIENT WAS FOUND TO HAVE AFIB WITH RATES RANGING FROM 54 TO 66. A CHEST X-RAY SHOWED BILATERAL ATELECTASIS/PLEURAL EFFUSIONS (ACCUMULATION OF FLUID IN THE THIN MEMBRANE SURROUNDING THE LUNG). THE FOLLOWING DAY, THE AFIB WAS MORE RAPID WITH FREQUENT PAUSES. THE PATIENT EVENTUALLY DETERIORATED TO ASYSTOLE (CARDIAC ARREST RHYTHM WITH NO DISCERNABLE ELECTRICAL ACTIVITY) AFTER RECEIVING A BETA BLOCKER. THEREAFTER, SHE WAS TRANSFERRED TO THE ICU AND RHYTHM RESUSCITATED. ON (B)(6) 2018, THE PATIENT WAS TAKEN TO THE ELECTROPHYSIOLOGY LAB AND A DDD PACEMAKER WAS PLACED. A CHEST X-RAY CONTINUED TO DEMONSTRATE BILATERAL PLEURAL EFFUSIONS. ON (B)(6), 2018, THE PATIENT WAS DISCHARGED TO A SKILLED NURSING FACILITY. UNFORTUNATELY, HER CONDITION WORSENED, AND SHE WAS BROUGHT BACK TO THE HOSPITAL ON (B)(6) 2018, WITH A SYMPTOMATIC ATRIAL FLUTTER WITH A RAPID VENTRICULAR RESPONSE. SHE WAS ALSO FOUND TO BE IN DIASTOLIC HEART FAILURE REQUIRING DIURESIS. THE PATIENT ULTIMATELY UNDERWENT SUCCESSFUL DC CARDIOVERSION TO TREAT HER AFIB AND WAS DISCHARGED BACK TO THE SKILLED NURSING FACILITY ON (B)(6) 2018. FOLLOWING DISCHARGE, THE PATIENT CONTINUED TO STRUGGLE WITH FLUID ACCUMULATION AND RESPIRATORY DISTRESS ASSOCIATED WITH DIASTOLIC HEART FAILURE. ON (B)(6) 2018, SHE RETURNED TO MISSION HOSPITAL WITH INCREASING SHORTNESS OF BREATH. SHE WAS FOUND TO HAVE ACUTE HYPOXEMIC RESPIRATORY FAILURE, ACUTE CONGESTIVE HEART FAILURE, AND HEALTH CARE ASSOCIATED PNEUMONIA. SHE WAS ADMITTED TO THE HOSPITAL AND TREATED WITH BROAD-SPECTRUM ANTIBIOTICS FOR 7 DAYS FOR HER PNEUMONIA. SHE WAS ALSO SEEN BY CARDIOLOGY AND AGGRESSIVELY DIURESED. THE PATIENT WAS NOTED TO HAVE LARGE BILATERAL PLEURAL EFFUSIONS AND WAS SEEN IN CONSULTATION BY A PULMONOLOGIST. THORACENTESIS WAS INITIALLY PERFORMED ON THE RIGHT SIDE WITH DRAMATIC IMPROVEMENT IN HER OXYGEN DEMANDS. SHE ALSO HAD A THORACENTESIS ON THE LEFT SIDE PERFORMED TO FURTHER IMPROVE HER PULMONARY STATUS. THE PATIENT WAS DISCHARGED BACK TO THE SKILLED NURSING FACILITY ON (B)(6), 2018. FOLLOWING DISCHARGE, THE PATIENT CONTINUED TO STRUGGLE WITH SEVERE RESPIRATORY DISTRESS SECONDARY TO DIASTOLIC HEART FAILURE. ON (B)(6), 2018, THE PATIENT DIED FROM HYPOXEMIC RESPIRATORY FAILURE SECONDARY TO DIASTOLIC HEART FAILURE.
(B)(4). IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).
SAME CASE AS MDR ID: 2134265-2018-02046 AND 2134265-2018-02047. IT WAS REPORTED THAT AN EMBOLIZATION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. THE PATIENT¿S ACTIVATED CLOTTING TIME (ACT) RANGE AFTER THE TRANSSEPTAL PUNCTURE WAS 241-357 AND A TRACE EFFUSION WAS NOTICED. THE LA PRESSURE WAS 13. A 30MM WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WAS SELECTED FOR USE. DURING PREPARATION, THE CLOSURE DEVICE WAS INADVERTENTLY DEPLOYED ON THE BACK TABLE BY THE TECHNICIAN. THIS DELIVERY SYSTEM WAS NOT USED. ANOTHER 30MM WDS WAS SELECTED. THIS WDS WAS PREPARED AND THEY WERE WATCHING FOR AIR. AIR WAS NOTICED IN THE WDS AS IT WAS BROUGHT TO THE STERILE TABLE. THEY REMOVED THE WDS FROM THE STERILE TABLE AND RE-PREPARED IT AGAIN LOOKING FOR AIR. AIR WAS NOT SEEN, SO IT WAS THEN USED IN THE PROCEDURE. THE WDS WAS ADVANCED INTO THE WATCHMAN ® ACCESS SYSTEM (WAS). THE CLOSURE DEVICE WAS DEPLOYED, BUT NOTED TO BE PROXIMAL SO A FULL RECAPTURE WAS PREFORMED AND THE WDS WAS REMOVED. AN EFFUSION SWEEP WAS PERFORMED AND SAW NO EFFUSION. A THIRD WDS WAS USED AND THIS TIME IT WAS A 27MM WDS. IT WAS PREPARED ON THE BACK TABLE AND THEY WERE LOOKING FOR AIR. THE SEAL OF THE CLOSURE DEVICE WAS BROKEN IN ORDER TO CORRECTLY PREPARE THE DEVICE. DURING PREPARATION OF THIS 27MM WDS, THE ECHO PHYSICIAN SAW A CLOT ON THE RIGHT SIDE OF THE HEART ON THE SEPTUM. THE WAS WAS PULLED BACK ACROSS THE SEPTUM WHILE BEING ASPIRATED WITH A SYRINGE IN AN ATTEMPT TO REMOVE THE CLOT. ONCE THE SHEATH WAS REMOVED THE CLOT WAS NO LONGER SEEN ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND THE PATIENT REMAINED STABLE. AS THE WAS WAS REMOVED, IT WAS NOTED THAT THERE WAS A KINK IN THE WAS NEAR THE 33MM MARKER BAND. THE WAS WAS THEN EXCHANGED FOR A SECOND DOUBLE CURVE WAS (LOT 21470960). LAA POSITION WAS REGAINED, THE ¿APPENDOGRAM¿ WAS RETAKEN, AND THE 27MM DEVICE WAS PREPARED. THE FEET OF THE DEVICE WERE MOVED TO ENSURE THEY WERE POSITIONED AT THE DISTAL MARKER BAND OF THE DEPLOYMENT SYSTEM. NO AIR BUBBLES WERE NOTED IN THE WDS. THE WDS WAS ADVANCED INTO THE WAS. AS THE DISTAL MARKER BANDS WERE BEING ALIGNED, AN AIR BUBBLE WAS NOTED IN THE WDS. THE WDS WAS REMOVED AND RE-PREPPED AND THEY WERE AGAIN LOOKING FOR AIR. NO AIR BUBBLES WERE NOTED AND THE FEET OF THE DEVICE WERE ALIGNED WITH THE DISTAL MARKER BAND. THE FEET OF THE CLOSURE DEVICE WERE NOTED TO HAVE MOVED FORWARD PAST DISTAL MARKER BAND WHEN THE WDS WAS BROUGHT TO STERILE TABLE AND THE PHYSICIAN WAS PREPARING TO ADVANCE INTO THE BODY. AIR WAS INTRODUCED WHEN PULLING THE FEET BACK TO MARKER BAND ALIGNMENT, SO THE WDS WAS RE-PREPPED ON THE BACK TABLE. THE PROPERLY ALIGNED WDS WAS THEN INSERTED INTO THE WAS. THE WDS WAS THEN ADVANCED UNTIL THE DISTAL MARKER BANDS WERE ALIGNED AND THE WAS AND WDS WERE NOW SNAPPED AS A SYSTEM. THEY WERE DEEP SEATED IN THE LAA, SO THEY WANTED TO MAKE SURE THEY WATCH THE BACK WALL OF THE LAA UPON DEPLOYMENT. AS THE CLOSURE DEVICE WAS DEPLOYED, IT WAS NOTED THE FEET OF THE DEVICE WERE COMING BACK SLIGHTLY. ONCE THE DEVICE WAS DEPLOYED, IT IMMEDIATELY EMBOLIZED INTO THE LEFT ATRIUM. THE CORE WIRE AND THE DEVICE WERE NOT ATTACHED UPON DEPLOYMENT ALLOWING FOR THE DEVICE TO EMBOLIZE AND MOVE FREELY IN THE LEFT ATRIUM. THE WDS WAS REMOVED AND THE WAS WAS KEPT IN PLACE. THE DEVICE REMAINED IN THE LEFT ATRIUM. THE PATIENT REMAINED STABLE. PRADAXA WAS REVERSED WITH PRAXBIND. A 25MM NON-BSC GOOSE NECK SNARE WAS INSERTED INTO THE SHEATH IN AN ATTEMPT TO SNARE THE DEVICE. AT THE SAME TIME THE, OPERATING ROOM WAS CALLED AND MADE AWARE OF A POTENTIAL EMERGENT CASE. AS THE PHYSICIAN WAS ATTEMPTING TO SNARE THE DEVICE, THE DEVICE BECAME LODGED IN THE MITRAL VALVE ANNULUS WITH THE FABRIC FACING TOWARD THE ATRIUM. THE PATIENT BECAME HEMODYNAMICALLY COMPROMISED, DEVELOPING HYPOTENSION. THE TEE WAS MAINTAINED AND THE VIEW OF DEVICE WAS CONTINUOUS. NOREPINEPHERINE AND LEVOPHED WERE STARTED TO HELP MANAGE THE PATIENT¿S BLOOD PRESSURE. RIGHT FEMORAL ARTERIAL ACCESS WAS GAINED VIA A MODIFIED SELDINGER TECHNIQUE, AND A 7F SHEATH WAS PLACED. UNDER FLUOROSCOPIC GUIDANCE, AN INTRA-ARTERIAL BALLOON PUMP (IABP) WAS INSERTED TO ASSIST WITH HEMODYNAMIC INSTABILITY. AUGMENTATION WAS EXCELLENT AT A 1:1 RATIO. THE PATIENT¿S BLOOD PRESSURE IMPROVED MARKEDLY ONCE THE IABP WAS PLACED. THE OPERATING ROOM (OR) WAS NOTIFIED THAT THIS WAS AN EMERGENT PATIENT AND A ROOM WAS PREPARED. THE PATIENT REMAINED STABLE ON CARDIAC SUPPORT. THE CLOSURE DEVICE WAS NOTED TO HAVE MIGRATED TO LEFT VENTRICLE UPON ARRIVAL TO OR. A CARDIOVASCULAR SURGEON REMOVED THE CLOSURE DEVICE, LIGATED THE LAA, AND THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT. THERE WAS MILD TO MODERATE MITRAL REGURGITATION SEEN ON ECHOCARDIOGRAM AND THE PATIENT WAS BEING WEANED OFF PHARMACOLOGICAL SUPPORT. THE PATIENT WAS STABLE THAT EVENING AND WAS DISCHARGED THE FOLLOWING WEEK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 170015 | WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM | SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL | NGV | BOSTON SCIENTIFIC CORPORATION | 10371 | 0021428671 | 08714729838241 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Female | Hospitalization| R| D |