FDA.reportPublic FDA data

MAUDE MDR 9848184

MDR report key
9848184
Report number
2134265-2020-03383
Event key
0
Event type
3
Date of event
2020-02-19
Date received
2020-03-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
JAY JOHNSON
Address
TWO SCIMED PLACE MAPLE GROVE MN 55311 US
Phone
763-763-7634
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEMSYSTEM, APPENDAGE CLOSURE, LEFT ATRIALBOSTON SCIENTIFIC CORPORATIONNGV10365103650023329766R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-1801. O

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT THERE WAS A PERFORATION AND A PERICARDIAL EFFUSION. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. THERE WAS NO THROMBUS OR PERICARDIAL EFFUSION NOTED AT BASELINE. DURING THE TRANS-SEPTAL PUNCTURE, ST ELEVATION OCCURRED AND AIR WAS NOTED IN THE LAA. PURE OXYGEN ADMINISTRATION WAS IMMEDIATELY STARTED, AND THE AIR BUBBLES WERE CHECKED IN THE LAA BY TEE. THE PATIENT'S BLOOD PRESSURE DECREASED, BUT IT WAS TEMPORARY. THE RISING ST ALSO IMPROVED. THE WATCHMAN ACCESS SYSTEM (WAS) AND PIG TAIL CATHETER WERE INSERTED INTO THE PATIENT AND BLOOD WAS SUCTIONED FROM THE SIDE PORT OF WAS, AND THE PHYSICIAN TRIED TO REMOVE AIR BUBBLES IN LAA. SOME AIR BUBBLES SLIGHTLY REMAINED IN THE DISTAL END OF THE LAA, BUT THE PHYSICIAN FELT THERE WAS NO PROBLEM AND CONTINUED THE PROCEDURE WITH NO FURTHER ST CHANGES. THESE PRIOR EVENTS WERE NOT RELATED TO THE WATCHMAN DEVICES. A 30MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WAS CHOSEN. THE WAS WAS POSITIONED IN THE LAA AND THE WDS WAS INSERTED INTO IT. THE CLOSURE DEVICE WAS DEPLOYED TWICE IN THE LAA AND DID NOT MEET RELEASE CRITERIA. BOTH TIMES THE PHYSICIAN PERFORMED A PARTIAL RECAPTURE. FOLLOWING THE SECOND PARTIAL RECAPTURE IT WAS NOTED THAT THERE WAS A PERFORATION AND A SMALL PERICARDIAL EFFUSION THAT WAS PRESENT AROUND THE LAA AND AROUND THE RIGHT VENTRICLE (RV). THE PROCEDURE CONTINUED AND THE CLOSURE DEVICE WAS DEPLOYED A THIRD TIME IN THE LAA OF THE PATIENT. THE CLOSURE DEVICE MET RELEASE CRITERIA AND WAS RELEASED FROM THE CORE WIRE AND IMPLANTED IN THE LAA. THE WAS AND WDS WERE REMOVED FROM THE PATIENT. PROTAMINE WAS ADMINISTERED, AND HEPARIN NEUTRALIZATION WAS PLANNED. FIVE MINUTES LATER, THE PATIENTS BLOOD PRESSURE STARTED TO DECREASE. EVALUATION BY TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS CONTINUED AND THERE WAS NO CHANGE AROUND THE LAA AND 1-2 MM CHANGE AROUND THE RV. PERICARDIAL DRAINAGE WAS NOT NECESSARY SINCE THE PATIENT'S HEMODYNAMICS WERE STABLE. THE PATIENT WAS TRANSFERRED TO THE CRITICAL CARE UNIT. THE PATIENT IS DOING FINE AND THERE WERE NO OTHER COMPLICATIONS THAT WERE REPORTED.