FLEXNAV DELIVERY SYSTEM
Report
- Report Number
- 2135147-2023-04561
- Event Type
- Malfunction
- Date Received
- October 17, 2023
- Date of Event
- September 27, 2023
- Report Date
- November 9, 2023
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- NPT
- UDI-DI
- 05415067031389
- PMA / PMN Number
- P190023
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
AN EVENT OF A DELIVERY SYSTEM DISLODGING A VALVE DURING REMOVAL AND CAUSING IT TO MIGRATE WAS REPORTED. INFORMATION FROM THE FIELD INDICATED THAT THERE WERE NO DIFFICULTIES DEPLOYING OR RETRACTING THE VALVE BUT THAT DURING REMOVAL OF THE DELIVERY SYSTEM THE VALVE MIGRATED A FEW CENTIMETERS INTO THE ASCENDING AORTA. THE FIELD INDICATED THAT THE VALVE DID NOT BLOCK A CORONARY ARTERY AND WAS SNARED INTO THE UPPER AORTA. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED, AND THE PRODUCT MET ALL SPECIFICATIONS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.
INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.
IT WAS REPORTED THAT ON (B)(6) 2023, A 29MM NAVITOR VALVE (19535741) WAS CHOSEN FOR IMPLANT USING A FLEXNAV DELIVERY SYSTEM (8890746) DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION. IT WAS REPORTED THE AORTIC VALVE ANNULUS HAD PERIMETER 79.2MM, MINIMUM DIAMETER 22.5MM, DIAMETER MAXIMUM 27.8MM, AND DIAMETER AVERAGE 25.2MM. THE PATIENT DID NOT HAVE A HORIZONTAL AORTA. THE VALVE WAS OPENED IN A HIGH POSITION AT 0MM TO +1MM. THE STARTING IMPLANT DEPTH AT DEPLOYMENT WAS +1MM, AND THE FINAL IMPLANT DEPTH AT RELEASE WAS +1MM. IT WAS REPORTED THERE WAS SUFFICIENT CALCIUM TO ALLOW ANCHORING, AND THERE WAS TENSION IN THE DELIVERY SYSTEM AT THE TIME OF FINAL DEPLOYMENT. IT WAS CONFIRMED VIA IMAGING THAT ALL THREE RETAINER TABS HAD RELEASED PRIOR TO REMOVAL OF THE DELIVERY SYSTEM. THERE WERE NO DIFFICULTIES IN DEPLOYING OR RETRACTING THE VALVE, AND THE VALVE WAS NEVER RE-SHEATHED MORE THAN TWO TIMES. DURING REMOVAL OF THE DELIVERY SYSTEM, THE DELIVERY SYSTEM TOUCHED AND PULLED UP THE VALVE, CAUSING IT TO MIGRATE A FEW CENTIMETERS INTO THE ASCENDING AORTA. THE MIGRATED VALVE DID NOT REMAIN WITHIN THE AORTIC ANNULUS AND DID NOT BLOCK A CORONARY ARTERY. THE DECISION WAS MADE TO SNARE THE DEVICE INTO THE UPPER AORTA. A SECOND 29MM NAVITOR VALVE (19544235) WAS CHOSEN FOR IMPLANT USING A NEW FLEXNAV DELIVERY SYSTEM (8872816). DURING THE DEPLOYMENT OF THE SECOND VALVE WHILE NAVIGATING THROUGH THE FIRST VALVE, THE TIP OF THE SECOND DELIVERY SYSTEM TOUCHED THE FIRST VALVE AND MAY HAVE CREATED PRESSURE OF THE FIRST VALVE ON THE DISTAL END OF THE AORTA. THE SECOND VALVE WAS POSITIONED AND FULLY IMPLANTED. HOWEVER, IT WAS NOTED THAT THE PATIENT'S BLOOD PRESSURE DECREASED, AND INTERNAL BLEEDING WAS DETECTED. RESUSCITATION WAS STARTED, AND THE PATIENT WAS SENT TO OPEN HEART SURGERY. IT WAS NOTED THAT THERE WAS AN AORTIC DISSECTION, WHICH WAS ATTEMPTED TO BE REPAIRED DURING SURGERY. IT WAS REPORTED THE CAUSE OF THE AORTIC DISSECTION WAS ATTRIBUTED TO THE INTERACTION BETWEEN THE SECOND DELIVERY SYSTEM AND THE FIRST VALVE. THE PATIENT DIED DUE TO MAJOR BLEEDING.
IT WAS REPORTED THAT ON (B)(6) 2023, A 29MM NAVITOR VALVE (19535741) WAS CHOSEN FOR IMPLANT USING A FLEXNAV DELIVERY SYSTEM (8890746) DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION. IT WAS REPORTED THE NATIVE VALVE'S MEASUREMENTS WERE AS FOLLOWS: PERIMETER=79.2MM, AORTIC ANNULUS (AA) DIAMETER MIN=22.5MM, AA DIAMETER MAX=27.8MM, AND AA DIAMETER AVERAGE=25.2MM. THE PATIENT DID NOT HAVE A HORIZONTAL AORTA. THE VALVE WAS OPENED IN A HIGH POSITION AT 0MM TO +1MM. THE IMPLANT DEPTH AT DEPLOYMENT WAS +1MM AND THE IMPLANT DEPTH AT RELEASE WAS +1MM. IT WAS REPORTED THERE WAS SUFFICIENT CALCIUM TO ALLOW ANCHORING AND THERE WAS TENSION IN THE DELIVERY SYSTEM AT THE TIME OF FINAL DEPLOYMENT. IT WAS CONFIRMED VIA IMAGING THAT ALL THREE RETAINER TABS HAD RELEASED PRIOR TO REMOVAL OF THE DELIVERY SYSTEM. THERE WERE NO DIFFICULTIES IN DEPLOYING OR RETRACTING THE VALVE AND THE VALVE WAS NEVER RESHEATHED MORE THAN TWO TIMES. DURING REMOVAL OF THE DELIVERY SYSTEM, THE DELIVERY SYSTEM TOUCHED AND PULLED UP THE VALVE, CAUSING IT TO MIGRATE A FEW CENTIMETERS INTO THE ASCENDING AORTA. THE MIGRATED VALVE DID NOT REMAIN WITHIN THE AORTIC ANNULUS AND DID NOT BLOCK A CORONARY ARTERY. THE DECISION WAS MADE TO SNARE THE DEVICE INTO THE UPPER AORTA. A SECOND 29MM NAVITOR VALVE (19544235) WAS CHOSEN FOR IMPLANT USING A NEW FLEXNAV DELIVERY SYSTEM (8872816). DURING THE DEPLOYMENT OF THE SECOND VALVE WHILE NAVIGATING THROUGH THE FIRST VALVE, THE TIP OF THE SECOND DELIVERY SYSTEM TOUCHED THE FIRST VALVE AND MAY HAVE CREATED PRESSURE OF THE FIRST VALVE ON THE DISTAL END OF THE AORTA. THE SECOND VALVE WAS POSITIONED AND FULLY IMPLANTED. HOWEVER, IT WAS NOTED THAT THE PATIENT'S BLOOD PRESSURE DECREASED, AND INTERNAL BLEEDING WAS DETECTED. RESUSCITATION WAS STARTED, AND THE PATIENT WAS SENT TO OPEN HEART SURGERY. IT WAS NOTED THAT THERE WAS AN AORTIC DISSECTION, WHICH WAS ATTEMPTED TO BE REPAIRED DURING SURGERY. IT WAS REPORTED THE CAUSE OF THE AORTIC DISSECTION WAS ATTRIBUTED TO THE INTERACTION BETWEEN THE SECOND DELIVERY SYSTEM AND THE FIRST VALVE. THE PATIENT DIED DUE TO MAJOR BLEEDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1652856 | FLEXNAV DELIVERY SYSTEM | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED | NPT | ABBOTT MEDICAL | 8890746 | 05415067031389 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Male |