WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM
Report
- Report Number
- 2124215-2022-44980
- Event Type
- Injury
- Date Received
- November 3, 2022
- Date of Event
- October 24, 2022
- Report Date
- December 7, 2022
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NGV
- UDI-DI
- 08714729860501
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DEVICE EVALUATED BY MFR.: THE RETURNED PRODUCT CONSISTED OF A 27MM WATCHMAN FLX DELIVERY SYSTEM (FLX) WITH THE IMPLANT IN THE SHEATH, AND BLOOD IN THE DEVICE. THE HUB, SHAFT, TIP, IMPLANT, AND CORE WIRE WERE VISUALLY, TACTILELY, AND MICROSCOPICALLY EXAMINED. INSPECTION OF THE DEVICE REVEALED TIP DAMAGE AS THE TRI-CUTS WERE FLARED AND THERE WERE ABRASIONS ON THE INSIDE OF THE SHEATH TIP. INSPECTION OF THE REMAINDER OF THE DEVICE FOUND NO OTHER DAMAGE OR DEFECTS. PRODUCT ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT AS CLINICAL CIRCUMSTANCES COULD NOT BE REPLICATED.
IT WAS REPORTED THAT AIR EMBOLISM, ST SEGMENT ELEVATION AND BRADYCARDIA OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. RIGHT FEMORAL VEIN ACCESS WAS OBTAINED TWICE AND AN 11FR AND 16FR SHEATHS WERE INSERTED OVER THE GUIDEWIRE INTO THE RIGHT FEMORAL VEIN. A 10FR INTRACARDIAC ECHO (ICE) PROBE WAS INSERTED INTO THE 11FR SHEATH. THE ICE PROBE WAS ADVANCED TO THE RIGHT ATRIUM TO VISUALIZE THE LAA FOR VERIFICATION OF LACK OF THROMBUS, THEN TO VISUALIZE INTRA ATRIAL SEPTUM FOR THE TRANSEPTAL PUNCTURE. THE SEPTUM WAS CROSSED INFERIOR AND MID USING A NON-BOSTON SCIENTIFIC (BSC) SHEATH WITH NO COMPLICATION. THE NON-BSC PIGTAIL WIRE WAS ADVANCED INTO THE LEFT ATRIUM (LA)/ LEFT UPPER PULMONARY VEIN FOR EXCHANGE OF THE NON-BSC SHEATH FOR THE WATCHMAN FXD DOUBLE CURVE ACCESS SYSTEM. THE WATCHMAN FXD DOUBLE CURVE WAS USED TO DILATE THE SEPTUM THREE TIMES. THE WATCHMAN FXD DOUBLE CURVE WAS PULLED BACK TO THE INFERIOR VENA CAVA. THE ICE PROBE WAS ADVANCED ACROSS THE SEPTUM INTO THE LA. THE WATCHMAN FXD DOUBLE CURVE WAS THEN ADVANCED TO THE LA. THE WATCHMAN FXD DOUBLE CURVE DILATOR WAS REMOVED AND THE 6FR PIGTAIL CATHETER WAS INSERTED OVER THE NON-BSC GUIDEWIRE INTO THE LA. THE NON-BSC GUIDEWIRE WAS THEN REMOVED. THE ICE PROBE USED FOR VISUALIZATION OF THE LAA. THE PIGTAIL CATHETER WAS ADVANCED IN TO THE LAA USING FLUOROSCOPY AND ICE. THE LA PRESSURE SHOWED A MEAN OF 6. A FLUID BOLUS WAS INITIATED BY THE NURSE. THE PHYSICIAN ALSO BOLUSED APPROXIMATELY 500CC FLUID THROUGH THE PIGTAIL CATHETER DIRECTLY INTO THE LEFT ATRIUM. THE LEFT ATRIAL PRESSURE TO 10 AND CONTRAST INJECTION PERFORMED OF LAA. A 31MM WATCHMAN FLX DEVICE PREP WAS PERFORMED ENSURING NO AIR WAS PRESENT. THE PIGTAIL CATHETER WAS REMOVED. THE 31MM WATCHMAN FLX DEVICE WAS INSERTED ENSURING WET TO WET INSERTION. THE WATCHMAN FLX 31MM DEVICE WAS ADVANCED USING FLUOROSCOPY GUIDANCE TO ALIGN DISTAL MARKERS. THERE WAS LIMITED ANTERIOR DEPTH, SO A PARTIAL RECAPTURE PERFORMED. THEY REDEPLOYED THE WATCHMAN FLX 31MM DEVICE WITH SIMILAR RESULT OF LARGE SHOULDER AND POOR ANCHOR ENGAGEMENT. IT WAS DETERMINED THAT A SMALLER WATCHMAN DEVICE WOULD HAVE TO BE UTILIZED TO OBTAIN POSTERIOR DEPTH. THEY PREPPED A 27MM WATCHMAN FLX ENSURING NO AIR PRESENT. THE 31MM WATCHMAN DEVICE WAS REMOVED FROM THE WATCHMAN FXD DOUBLE CURVE AND THE 27MM WATCHMAN FLX DEVICE WAS INSERTED ENSURING WET TO WET INSERTION. USING FLUOROSCOPY GUIDANCE, THE DISTAL MARKERS WERE ALIGNED. THE 27MM WATCHMAN FLX DEVICE WAS DEPLOYED IN SUB OPTIMAL POSITION. A PARTIAL RECAPTURE AND REDEPLOYMENT WERE PERFORMED WITH SIMILAR RESULT. A DISCUSSION WITH THE PHYSICIAN WAS HAD ABOUT THE NEED TO POTENTIALLY USE A SINGLE CURVE SHEATH AND POSSIBLY RESTICK THE SEPTUM. THE PHYSICIAN DEPLOYED AGAIN AND AT THAT POINT AN AIR EMBOLUS WAS NOTED CROSSING THE AORTIC VALVE INTO THE ASCENDING AORTA AND RIGHT CORONARY ARTERY. THE POSITIONING OF THE 27MM WATCHMAN FLX DEVICE WAS SUB OPTIMAL AND THE PHYSICIAN WAS ATTEMPTING TO DO PARTIAL RECAPTURES AND REDEPLOY. THE PATIENT'S VITALS DETERIORATED RAPIDLY. THE WATCHMAN SHEATH AND 27MM WATCHMAN FLX DEVICE WERE REMOVED FROM THE BODY. A NON-REBREATHER WAS STARTED, AND THE PATIENT WAS PLACED IN REVERSE TRENDELENBURG. ST ELEVATION WAS NOTED, AND HEART RATE STARTED TO BRADYCARDIA DOWN. EPINEPHRINE WAS GIVEN. A TEMPORARY PACEMAKER WAS INSERTED TO MAINTAIN A BASELINE RATE OF 80 BPM. ARTERIAL ACCESS WAS OBTAINED FOR LEFT HEART CATHETERIZATION. THE PATIENT WENT INTO VENTRICULAR TACHYCARDIA AND VENTRICULAR FIBRILLATION WHICH WAS CORRECTED WITH DEFIBRILLATION THERAPY. A 6FR NON-BSC CATHETER WAS INSERTED INTO THE OSTIUM OF THE RIGHT CORONARY ARTERY (RCA) WHICH WAS FOUND TO BE TOTALLY OCCLUDED AT THE OSTIUM DUE TO OBSTRUCTION OF AIR. THE PATIENT HAD TWO MORE VENTRICULAR EVENTS WHICH WERE CORRECTED WITH DEFIBRILLATION THERAPY. THE PHYSICIAN CALLED FOR ANESTHESIA TO INTUBATE PATIENT. A LEVOPHED DRIP WAS INITIATED. A CORONARY WIRE WAS INSERTED INTO THE NON-BSC CATHETER INTO THE RCA TO MOVE AIR. SLOW FLOW CIRCULATION WAS RESTORED TO THE RCA WHICH LED TO TWO MORE VENTRICULAR ARRHYTHMIAS REQUIRING DEFIBRILLATION THERAPY. THE CORONARY WIRE WAS ADVANCED TO THE DISTAL RCA AND CIRCULATION WAS FULLY RESTORED. A TEMPORARY PACEMAKER WAS REDUCED TO 40 BPM TO SEARCH FOR INTRINSIC ACTIVITY. INTRINSIC ACTIVITY WAS NOTED SO THE TEMPORARY PACEMAKER WAS SET TO A BACKUP RATE OF 50 BPM. THE NON-BSC CATHETER AND WIRE WERE REMOVED AND LEFT CORONARY ANGIOGRAPHY WAS PERFORMED WITH NO OBSTRUCTIONS NOTED. RIGHT COMMON CAROTID ANGIOGRAPHY WAS PERFORMED WITH OBSTRUCTION NOTED. THE PHYSICIAN WAS UNABLE TO OBTAIN ACCESS TO THE LEFT CAROTID FOR VISUALIZATION. THE CATHETERS WERE REMOVED, AND THE PHYSICIAN PERFORMED A TRANSTHORACIC ECHOCARDIOGRAM TO CHECK FOR ANY EFFUSION. THE PHYSICIAN NOTED NO EFFUSION. THE PATIENT LEFT THE ROOM INTUBATED ON SEVERAL DRIPS. PATIENT STATUS: THE PATIENT IS RECOVERING WELL. THE INTUBATION TUBE WAS REMOVED THE FOLLOWING DAY AND ALL DRIPS STOPPED. THE PATIENT HAD LEFT SIDED WEAKNESS INITIALLY BUT HAD SEEN VAST IMPROVEMENT. MAGNETIC RESONANCE IMAGING (MRI) SHOWED NO ABNORMALITY.
IT WAS REPORTED THAT AIR EMBOLISM, ST SEGMENT ELEVATION AND BRADYCARDIA OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. RIGHT FEMORAL VEIN ACCESS WAS OBTAINED TWICE AND AN 11FR AND 16FR SHEATHS WERE INSERTED OVER THE GUIDEWIRE INTO THE RIGHT FEMORAL VEIN. A 10FR INTRACARDIAC ECHO (ICE) PROBE WAS INSERTED INTO THE 11FR SHEATH. THE ICE PROBE WAS ADVANCED TO THE RIGHT ATRIUM TO VISUALIZE THE LAA FOR VERIFICATION OF LACK OF THROMBUS, THEN TO VISUALIZE INTRA ATRIAL SEPTUM FOR THE TRANSEPTAL PUNCTURE. THE SEPTUM WAS CROSSED INFERIOR AND MID USING A NON-BOSTON SCIENTIFIC (BSC) SHEATH WITH NO COMPLICATION. THE NON-BSC PIGTAIL WIRE WAS ADVANCED INTO THE LEFT ATRIUM (LA)/ LEFT UPPER PULMONARY VEIN FOR EXCHANGE OF THE NON-BSC SHEATH FOR THE WATCHMAN FXD DOUBLE CURVE ACCESS SYSTEM. THE WATCHMAN FXD DOUBLE CURVE WAS USED TO DILATE THE SEPTUM THREE TIMES. THE WATCHMAN FXD DOUBLE CURVE WAS PULLED BACK TO THE INFERIOR VENA CAVA. THE ICE PROBE WAS ADVANCED ACROSS THE SEPTUM INTO THE LA. THE WATCHMAN FXD DOUBLE CURVE WAS THEN ADVANCED TO THE LA. THE WATCHMAN FXD DOUBLE CURVE DILATOR WAS REMOVED AND THE 6FR PIGTAIL CATHETER WAS INSERTED OVER THE NON-BSC GUIDEWIRE INTO THE LA. THE NON-BSC GUIDEWIRE WAS THEN REMOVED. THE ICE PROBE USED FOR VISUALIZATION OF THE LAA. THE PIGTAIL CATHETER WAS ADVANCED IN TO THE LAA USING FLUOROSCOPY AND ICE. THE LA PRESSURE SHOWED A MEAN OF 6. A FLUID BOLUS WAS INITIATED BY THE NURSE. THE PHYSICIAN ALSO BOLUSED APPROXIMATELY 500CC FLUID THROUGH THE PIGTAIL CATHETER DIRECTLY INTO THE LEFT ATRIUM. THE LEFT ATRIAL PRESSURE TO 10 AND CONTRAST INJECTION PERFORMED OF LAA. A 31MM WATCHMAN FLX DEVICE PREP WAS PERFORMED ENSURING NO AIR WAS PRESENT. THE PIGTAIL CATHETER WAS REMOVED. THE 31MM WATCHMAN FLX DEVICE WAS INSERTED ENSURING WET TO WET INSERTION. THE WATCHMAN FLX 31MM DEVICE WAS ADVANCED USING FLUOROSCOPY GUIDANCE TO ALIGN DISTAL MARKERS. THERE WAS LIMITED ANTERIOR DEPTH, SO A PARTIAL RECAPTURE PERFORMED. THEY REDEPLOYED THE WATCHMAN FLX 31MM DEVICE WITH SIMILAR RESULT OF LARGE SHOULDER AND POOR ANCHOR ENGAGEMENT. IT WAS DETERMINED THAT A SMALLER WATCHMAN DEVICE WOULD HAVE TO BE UTILIZED TO OBTAIN POSTERIOR DEPTH. THEY PREPPED A 27MM WATCHMAN FLX ENSURING NO AIR PRESENT. THE 31MM WATCHMAN DEVICE WAS REMOVED FROM THE WATCHMAN FXD DOUBLE CURVE AND THE 27MM WATCHMAN FLX DEVICE WAS INSERTED ENSURING WET TO WET INSERTION. USING FLUOROSCOPY GUIDANCE, THE DISTAL MARKERS WERE ALIGNED. THE 27MM WATCHMAN FLX DEVICE WAS DEPLOYED IN SUB OPTIMAL POSITION. A PARTIAL RECAPTURE AND REDEPLOYMENT WERE PERFORMED WITH SIMILAR RESULT. A DISCUSSION WITH THE PHYSICIAN WAS HAD ABOUT THE NEED TO POTENTIALLY USE A SINGLE CURVE SHEATH AND POSSIBLY RESTICK THE SEPTUM. THE PHYSICIAN DEPLOYED AGAIN AND AT THAT POINT AN AIR EMBOLUS WAS NOTED CROSSING THE AORTIC VALVE INTO THE ASCENDING AORTA AND RIGHT CORONARY ARTERY. THE POSITIONING OF THE 27MM WATCHMAN FLX DEVICE WAS SUB OPTIMAL AND THE PHYSICIAN WAS ATTEMPTING TO DO PARTIAL RECAPTURES AND REDEPLOY. THE PATIENT'S VITALS DETERIORATED RAPIDLY. THE WATCHMAN SHEATH AND 27MM WATCHMAN FLX DEVICE WERE REMOVED FROM THE BODY. A NON-REBREATHER WAS STARTED, AND THE PATIENT WAS PLACED IN REVERSE TRENDELENBURG. ST ELEVATION WAS NOTED, AND HEART RATE STARTED TO BRADYCARDIA DOWN. EPINEPHRINE WAS GIVEN. A TEMPORARY PACEMAKER WAS INSERTED TO MAINTAIN A BASELINE RATE OF 80 BPM. ARTERIAL ACCESS WAS OBTAINED FOR LEFT HEART CATHETERIZATION. THE PATIENT WENT INTO VENTRICULAR TACHYCARDIA AND VENTRICULAR FIBRILLATION WHICH WAS CORRECTED WITH DEFIBRILLATION THERAPY. A 6FR NON-BSC CATHETER WAS INSERTED INTO THE OSTIUM OF THE RIGHT CORONARY ARTERY (RCA) WHICH WAS FOUND TO BE TOTALLY OCCLUDED AT THE OSTIUM DUE TO OBSTRUCTION OF AIR. THE PATIENT HAD TWO MORE VENTRICULAR EVENTS WHICH WERE CORRECTED WITH DEFIBRILLATION THERAPY. THE PHYSICIAN CALLED FOR ANESTHESIA TO INTUBATE PATIENT. A LEVOPHED DRIP WAS INITIATED. A CORONARY WIRE WAS INSERTED INTO THE NON-BSC CATHETER INTO THE RCA TO MOVE AIR. SLOW FLOW CIRCULATION WAS RESTORED TO THE RCA WHICH LED TO TWO MORE VENTRICULAR ARRHYTHMIAS REQUIRING DEFIBRILLATION THERAPY. THE CORONARY WIRE WAS ADVANCED TO THE DISTAL RCA AND CIRCULATION WAS FULLY RESTORED. A TEMPORARY PACEMAKER WAS REDUCED TO 40 BPM TO SEARCH FOR INTRINSIC ACTIVITY. INTRINSIC ACTIVITY WAS NOTED SO THE TEMPORARY PACEMAKER WAS SET TO A BACKUP RATE OF 50 BPM. THE NON-BSC CATHETER AND WIRE WERE REMOVED AND LEFT CORONARY ANGIOGRAPHY WAS PERFORMED WITH NO OBSTRUCTIONS NOTED. RIGHT COMMON CAROTID ANGIOGRAPHY WAS PERFORMED WITH OBSTRUCTION NOTED. THE PHYSICIAN WAS UNABLE TO OBTAIN ACCESS TO THE LEFT CAROTID FOR VISUALIZATION. THE CATHETERS WERE REMOVED, AND THE PHYSICIAN PERFORMED A TRANSTHORACIC ECHOCARDIOGRAM TO CHECK FOR ANY EFFUSION. THE PHYSICIAN NOTED NO EFFUSION. THE PATIENT LEFT THE ROOM INTUBATED ON SEVERAL DRIPS. PATIENT STATUS: THE PATIENT IS RECOVERING WELL. THE INTUBATION TUBE WAS REMOVED THE FOLLOWING DAY AND ALL DRIPS STOPPED. THE PATIENT HAD LEFT SIDED WEAKNESS INITIALLY BUT HAD SEEN VAST IMPROVEMENT. MAGNETIC RESONANCE IMAGING (MRI) SHOWED NO ABNORMALITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2817734 | WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM | SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL | NGV | BOSTON SCIENTIFIC CORPORATION | 10390 | 0028748911 | 08714729860501 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 YR | Male | Required Intervention |