NAVITOR TRANSCATHETER AORTIC VALVE
Report
- Report Number
- 2135147-2024-00791
- Event Type
- Death
- Date Received
- February 21, 2024
- Date of Event
- January 29, 2024
- Report Date
- March 22, 2024
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- NPT
- UDI-DI
- 05415067031594
- PMA / PMN Number
- P190023
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.
AN EVENT OF MIGRATION, PARAVALVULAR LEAK (PVL), VALVE UNDEREXPANSION, PATIENT DEVICE INTERACTION PROBLEM, OFF-LABEL USE, IMPROPER OR INCORRECT PROCEDURE OR METHOD, AND DEATH WAS REPORTED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED, AND THE PRODUCT MET ALL SPECIFICATIONS. POSSIBLE CONTRIBUTING FACTORS FOR VALVE MIGRATION ARE INTRA-PROCEDURAL DIFFICULTIES, IMPLANT DEPTH, ANNULAR CALCIUM DISTRIBUTION, AND DEPLOYMENT OR RETRACTION DIFFICULTIES. INFORMATION FROM THE FIELD INDICATED THAT THE PATIENT HAD A HORIZONTAL AORTA, THERE WAS NO TENSION IN THE DELIVERY SYSTEM DURING DEPLOYMENT, THE VALVE LOOKED CONSTRAINED DUE TO THE SEVERE CALCIFICATION, MODERATE PVL WAS PRESENT, AND THE VALVE MIGRATED AFTER POST-BALLOON ANNULAR VALVULOPLASTY (BAV) WAS PERFORMED. THE VALVE WAS SNARED. A CT SCAN WAS TAKEN WHICH ALSO REVEALED MULTI TERRITORY STROKE AS WELL AS AORTIC DISSECTION IN THE ASCENDING AORTA. IT WAS THOUGHT THIS DISSECTION WAS DUE TO SNARING THE MIGRATED VALVE ALONG WITH DIFFICULTY CROSSING THE HORIZONTAL AORTA WITH BOTH FLEXNAV DELIVERY SYSTEMS. IT WAS THOUGHT THE STROKE WAS RELATED TO BOTH VALVES CAUSING DEBRIS EMBOLIZATION, MULTIPLE BALLOON VALVULOPLASTY'S, AND DIFFICULTY CROSSING AORTIC VALVE DUE TO HORIZONTAL ANGLE WITH BOTH FLEXNAV DELIVERY SYSTEMS. THE PATIENT DIED THREE DAYS POST-PROCEDURE. THE CAUSE OF DEATH WAS DUE TO THE AORTIC DISSECTION AND STROKE. THE EVENT WAS FURTHER REVIEWED BY AN ABBOTT SENIOR DIRECTOR OF MEDICAL AFFAIRS. BASED ON AVAILABLE INFORMATION, THE REPORTED EVENT APPEARS TO BE RELATED TO A COMBINATION OF PROCEDURAL CONDITIONS (VALVE MIGRATION, MULTIPLE BALLOON VALVULOPLASTY'S, DECISION TO SNARE VALVE, ETC.) AND PATIENT CONDITION (SEVERE CALCIFICATION, HORIZONTAL AORTA). THE REPORTED OFF-LABEL USE IS RELATED TO THE VALVE BEING USED ON A PATIENT WITH A BICUSPID AORTIC VALVE. THE REPORTED IMPROPER OR INCORRECT PROCEDURE OR METHOD IS RELATED TO THE USER SNARING THE VALVE AFTER DEPLOYMENT. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH REGARDS TO MANUFACTURE, DESIGN, OR LABELING.
AN EVENT OF MIGRATION, PARAVALVULAR LEAK (PVL), VALVE UNDEREXPANSION, PATIENT DEVICE INTERACTION PROBLEM, OFF-LABEL USE, IMPROPER OR INCORRECT PROCEDURE OR METHOD, AND DEATH WAS REPORTED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED, AND THE PRODUCT MET ALL SPECIFICATIONS. POSSIBLE CONTRIBUTING FACTORS FOR VALVE MIGRATION ARE INTRA-PROCEDURAL DIFFICULTIES, IMPLANT DEPTH, ANNULAR CALCIUM DISTRIBUTION, AND DEPLOYMENT OR RETRACTION DIFFICULTIES. INFORMATION FROM THE FIELD INDICATED THAT THE PATIENT HAD A HORIZONTAL AORTA, THERE WAS NO TENSION IN THE DELIVERY SYSTEM DURING DEPLOYMENT, THE VALVE LOOKED CONSTRAINED DUE TO THE SEVERE CALCIFICATION, MODERATE PVL WAS PRESENT, AND THE VALVE MIGRATED AFTER POST-BALLOON ANNULAR VALVULOPLASTY (BAV) WAS PERFORMED. THE VALVE WAS SNARED. A CT SCAN WAS TAKEN WHICH ALSO REVEALED MULTI TERRITORY STROKE AS WELL AS AORTIC DISSECTION IN THE ASCENDING AORTA. IT WAS THOUGHT THIS DISSECTION WAS DUE TO SNARING THE MIGRATED VALVE ALONG WITH DIFFICULTY CROSSING THE HORIZONTAL AORTA WITH BOTH FLEXNAV DELIVERY SYSTEMS. IT WAS THOUGHT THE STROKE WAS RELATED TO BOTH VALVES CAUSING DEBRIS EMBOLIZATION, MULTIPLE BALLOON VALVULOPLASTY'S, AND DIFFICULTY CROSSING AORTIC VALVE DUE TO HORIZONTAL ANGLE WITH BOTH FLEXNAV DELIVERY SYSTEMS. THE PATIENT DIED THREE DAYS POST-PROCEDURE. THE CAUSE OF DEATH WAS DUE TO THE AORTIC DISSECTION AND STROKE. THE EVENT WAS FURTHER REVIEWED BY AN ABBOTT SENIOR DIRECTOR OF MEDICAL AFFAIRS. BASED ON AVAILABLE INFORMATION, THE REPORTED EVENT APPEARS TO BE RELATED TO A COMBINATION OF PROCEDURAL CONDITIONS (VALVE MIGRATION, MULTIPLE BALLOON VALVULOPLASTY'S, DECISION TO SNARE VALVE, ETC.) AND PATIENT CONDITION (SEVERE CALCIFICATION, HORIZONTAL AORTA). THE REPORTED OFF-LABEL USE IS RELATED TO THE VALVE BEING USED ON A PATIENT WITH A BICUSPID AORTIC VALVE. THE REPORTED IMPROPER OR INCORRECT PROCEDURE OR METHOD IS RELATED TO THE USER SNARING THE VALVE AFTER DEPLOYMENT. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH REGARDS TO MANUFACTURE, DESIGN, OR LABELING.
IT WAS REPORTED THAT ON (B)(6) 2024, A 27MM NAVITOR VALVE WAS CHOSEN FOR IMPLANTATION INTO A BICUSPID AORTIC VALVE ANATOMY TYPE 1 UTILIZING AN UNKNOWN FLEXNAV DELIVERY SYSTEM. THE PATIENT PRESENTED WITH SEVERE CALICUM SCORE OF 6251, SEVERE AORTIC STENOSIS, AND HORIZONTAL AORTA. THE VALVE WAS PRE-DILATED WITH A 18MM BALLOON ((BALLOON ANNULAR VALVULOPLASTY (BAV)). A GUIDEWIRE AND A BUDDY WIRE WAS NEEDED TO TRAVERSE THE DIFFICULT HORIZONTAL AORTA. AT DEPLOYMENT, THE NAVITOR WAS PLACED AT 5MM IN LEFT CORONARY CUSP (LCC), 4MM IN NON-CORONARY CUSP (NCC), AND 5MM IN RIGHT CORONARY CUSP (RCC).AFTER FULL RELEASE, THE 27MM NAVITOR WAS AT 5MM IN LCC, 4 MM IN NCC AND 6MM IN RCC. NO TENSION IN DELIVERY SYSTEM DURING DEPLOYMENT. THE VALVE LOOKED CONSTRAINED DUE TO THE SEVERE CALCIFICATION AND MODERATE PERIVALVULAR LEAK (PVL) WAS PRESENT. POST-BAV DILATATION WAS PERFORMED WITH A 20MM BALLOON. ONCE THE BALLOON WAS REMOVED, THE NAVITOR MIGRATED SUPRA ANNULAR. THERE WAS NO BLOCKING OF CORONARY ARTERIES AND NO CLINICAL SIGNS OR SYMPTOMS DUE TO THE MIGRATION. THE VALVE WAS SNARED AND PLACED 5 CM ABOVE THE AORTIC ANNULUS. A REPLACEMENT 25MM NAVITOR (SERIAL:(B)(6)) WAS THEN IMPLANTED. DUE TO VALVE UNDER EXPANSION, POST-BAV DILATATION WAS PERFORMED WITH 20MM BALLOON SEVEN TIMES. GRADIENT OF 13MMHG. THE PROCEDURE ENDED WITH MILD PVL PRESENT ON ECHOCARDIOGRAM. THERE WAS REPORTEDLY A DELAY THAT RESULTED IN NO PATIENT EFFECTS. THE PATIENT IS REPORTED TO BE RECOVERING IN REHABILITATION UNIT. POST PROCEDURE, THE PATIENT SUFFERED A MULTI TERRITORY STROKE. COMPUTERIZED TOMAGRAPHY SCAN WAS TAKEN REVEALING AN AORTIC DISSECTION IN THE ASCENDING AORTA. IT WAS THOUGHT THIS DISSECTION WAS DUE TO SNARING THE MIGRATED VALVE. IT WAS THOUGHT THE STROKE WAS RELATED TO MULTIPLE BALLOON VALVULOPLASTY'S, VALVE POST-DILATATIONS AND CROSSING AORTIC VALVE DIFFICULT HORIZONTAL ANGLE. THE PATIENT DIED ON AN UNKNOWN DATE. THE CAUSE OF DEATH IS UNKNOWN.
IT WAS REPORTED THAT ON (B)(6) 2024, A 27MM NAVITOR VALVE WAS CHOSEN FOR IMPLANTATION INTO A BICUSPID AORTIC VALVE ANATOMY TYPE 1 UTILIZING A FLEXNAV DELIVERY SYSTEM. THE PATIENT PRESENTED WITH SEVERE CALICUM SCORE OF 6251, SEVERE AORTIC STENOSIS, AND HORIZONTAL AORTA. THE VALVE WAS PRE-DILATED WITH A 18MM BALLOON ((BALLOON ANNULAR VALVULOPLASTY (BAV)). A GUIDEWIRE AND A BUDDY WIRE WAS NEEDED TO TRAVERSE THE DIFFICULT HORIZONTAL AORTA. AT DEPLOYMENT, THE NAVITOR WAS PLACED AT 5MM IN LEFT CORONARY CUSP (LCC), 4MM IN NON-CORONARY CUSP (NCC), AND 5MM IN RIGHT CORONARY CUSP (RCC). AFTER FULL RELEASE, THE 27MM NAVITOR WAS AT 5MM IN LCC, 4 MM IN NCC AND 6MM IN RCC. NO TENSION IN DELIVERY SYSTEM DURING DEPLOYMENT. THE VALVE LOOKED CONSTRAINED DUE TO THE SEVERE CALCIFICATION AND MODERATE PERIVALVULAR LEAK (PVL) WAS PRESENT. POST-BAV DILATATION WAS PERFORMED WITH A 20MM BALLOON. ONCE THE BALLOON WAS REMOVED, THE NAVITOR MIGRATED SUPRA ANNULAR. THERE WAS NO BLOCKING OF CORONARY ARTERIES AND NO CLINICAL SIGNS OR SYMPTOMS DUE TO THE MIGRATION. THE VALVE WAS SNARED AND PLACED 5 CM ABOVE THE AORTIC ANNULUS. A REPLACEMENT 25MM NAVITOR (SERIAL:(B)(6)) WAS THEN IMPLANTED. DUE TO VALVE UNDER EXPANSION, POST-BAV DILATATION WAS PERFORMED WITH 20MM BALLOON SEVEN TIMES. GRADIENT OF 13MMHG. THE PROCEDURE ENDED WITH MILD PVL PRESENT ON ECHOCARDIOGRAM. THERE WAS REPORTEDLY A DELAY THAT RESULTED IN NO PATIENT EFFECTS. POST PROCEDURE, AFTER REMOVAL FROM GENERAL ANESTHESIA, THE PATIENT WAS CONFUSED AND HAVING TROUBLE WAKING UP. COMPUTERIZED TOMOGRAPHY SCAN WAS TAKEN WHICH ALSO REVEALED MULTI TERRITORY STROKE AS WELL AS AORTIC DISSECTION IN THE ASCENDING AORTA. IT WAS THOUGHT THIS DISSECTION WAS DUE TO SNARING THE MIGRATED VALVE ALONG WITH DIFFICULTY CROSSING THE HORIZONTAL AORTA WITH BOTH FLEXNAV DELIVERY SYSTEMS. IT WAS THOUGHT THE STROKE WAS RELATED TO BOTH VALVES CAUSING DEBRIS EMBOLIZATION, MULTIPLE BALLOON VALVULOPLASTY'S, AND DIFFICULTY CROSSING AORTIC VALVE DUE TO HORIZONTAL ANGLE WITH BOTH FLEXNAV DELIVERY SYSTEMS. THE PATIENT WAS NOT A SURGICAL CANDIDATE SO THEY WERE MANAGED MEDICALLY. PATIENT HAD THROMBOCYTOPENIA WHICH INCREASED RISK OF BLEEDING. THE PATIENT DIED THREE DAYS POST-PROCEDURE. THE CAUSE OF DEATH WAS DUE TO THE AORTIC DISSECTION AND STROKE.
IT WAS REPORTED THAT ON (B)(6) 2024, A 27MM NAVITOR VALVE WAS CHOSEN FOR IMPLANTATION INTO A BICUSPID AORTIC VALVE ANATOMY TYPE 1 UTILIZING A FLEXNAV DELIVERY SYSTEM. THE PATIENT PRESENTED WITH SEVERE CALICUM SCORE OF 6251, SEVERE AORTIC STENOSIS, AND HORIZONTAL AORTA. THE VALVE WAS PRE-DILATED WITH A 18MM BALLOON ((BALLOON ANNULAR VALVULOPLASTY (BAV)). A GUIDEWIRE AND A BUDDY WIRE WAS NEEDED TO TRAVERSE THE DIFFICULT HORIZONTAL AORTA. AT DEPLOYMENT, THE NAVITOR WAS PLACED AT 5MM IN LEFT CORONARY CUSP (LCC), 4MM IN NON-CORONARY CUSP (NCC), AND 5MM IN RIGHT CORONARY CUSP (RCC).AFTER FULL RELEASE, THE 27MM NAVITOR WAS AT 5MM IN LCC, 4 MM IN NCC AND 6MM IN RCC. NO TENSION IN DELIVERY SYSTEM DURING DEPLOYMENT. THE VALVE LOOKED CONSTRAINED DUE TO THE SEVERE CALCIFICATION AND MODERATE PERIVALVULAR LEAK (PVL) WAS PRESENT. POST-BAV DILATATION WAS PERFORMED WITH A 20MM BALLOON. ONCE THE BALLOON WAS REMOVED, THE NAVITOR MIGRATED SUPRA ANNULAR. THERE WAS NO BLOCKING OF CORONARY ARTERIES AND NO CLINICAL SIGNS OR SYMPTOMS DUE TO THE MIGRATION. THE VALVE WAS SNARED AND PLACED 5 CM ABOVE THE AORTIC ANNULUS. A REPLACEMENT 25MM NAVITOR (SERIAL:(B)(6)) WAS THEN IMPLANTED. DUE TO VALVE UNDER EXPANSION, POST-BAV DILATATION WAS PERFORMED WITH 20MM BALLOON SEVEN TIMES. GRADIENT OF 13MMHG. THE PROCEDURE ENDED WITH MILD PVL PRESENT ON ECHOCARDIOGRAM. THERE WAS REPORTEDLY A DELAY THAT RESULTED IN NO PATIENT EFFECTS. POST PROCEDURE, AFTER REMOVAL FROM GENERAL ANESTHESIA, THE PATIENT WAS CONFUSED AND HAVING TROUBLE WAKING UP. SUFFERED A . COMPUTERIZED TOMOGRAPHY SCAN WAS TAKEN WHICH ALSO REVEALED MULTI TERRITORY STROKE AS WELL AS AORTIC DISSECTION IN THE ASCENDING AORTA. IT WAS THOUGHT THIS DISSECTION WAS DUE TO SNARING THE MIGRATED VALVE ALONG WITH DIFFICULTY CROSSING THE HORIZONTAL AORTA WITH BOTH FLEXNAV DELIVERY SYSTEMS. IT WAS THOUGHT THE STROKE WAS RELATED TO BOTH VALVES CAUSING DEBRIS EMBOLIZATION, MULTIPLE BALLOON VALVULOPLASTY'S, AND DIFFICULTY CROSSING AORTIC VALVE DUE TO HORIZONTAL ANGLE WITH BOTH FLEXNAV DELIVERY SYSTEMS. THE PATIENT WAS NOT A SURGICAL CANDIDATE SO THEY WERE MANAGEMENT MEDICALLY. PATIENT HAD THROMBOCYTOPENIA WHICH INCREASED RISK OF BLEEDING. THE PATIENT DIED THREE DAYS POST-PROCEDURE. THE CAUSE OF DEATH WAS DUE TO THE AORTIC DISSECTION AND STROKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1575569 | NAVITOR TRANSCATHETER AORTIC VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED | NPT | ABBOTT MEDICAL | 8536595 | 05415067031594 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Female | Death| R |