NAVITOR VISION
Report
- Report Number
- 2135147-2024-04784
- Event Type
- Injury
- Date Received
- September 27, 2024
- Date of Event
- September 3, 2024
- Report Date
- October 23, 2024
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- NPT
- UDI-DI
- 05415067045782
- PMA / PMN Number
- P190023
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
AN EVENT OF THE PERIVALVULAR LEAK AND CEREBRAL INFARCTION WAS REPORTED. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED AND WAS NOT RETURNED FOR ANALYSIS. THE POSSIBLE CAUSES FOR PARAVALVULAR LEAK ARE SIZING OF THE VALVE, IMPLANT DEPTH, CALCIUM DISTRIBUTION, DEPLOYMENT DIFFICULTIES AND INADEQUATE RADIAL FORCES. IT WAS INDICATED THAT THERE WAS DIFFICULTY WIRING AT THE LEFT VENTRICLE. IT WAS ATTEMPTED 3 TIMES, AND IT WAS SUCCEEDED. IT WAS ALSO NOTED THAT UNIDENTIFIED DEBRIS NOTED DEEP INTO THE PERIPHERAL AND WAS DIFFICULT TO REMOVE WHICH MAY HAVE CONTRIBUTED THE REPORTED EVENT. 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 EVENT CANNOT BE CONFIRMED. PER THE INFORMATION AVAILABLE ABBOTT CANNOT FURTHER SPECULATE ON WHY THE REPORTED EVENT OCCURRED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING DESIGN OR MANUFACTURING OF THE DEVICE.
D4 - THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED.INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.
AN EVENT OF THE PERIVALVULAR LEAK AND CEREBRAL INFARCTION WAS REPORTED. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED AND WAS NOT RETURNED FOR ANALYSIS. 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 EVENT CANNOT BE CONFIRMED. PER THE INFORMATION AVAILABLE ABBOTT CANNOT FURTHER SPECULATE ON WHY THE REPORTED EVENT OCCURRED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING DESIGN OR MANUFACTURING OF THE DEVICE.
IT WAS REPORTED THAT ON (B)(6) 2024, A 25MM NAVITOR VALVE WAS SELECTED FOR IMPLANT USING A SMALL FLEXNAV DELIVERY SYSTEM (DS). THE ANNULAR DIMENSIONS OF THE PATIENT WERE APPROXIMATELY 21MM (AVERAGE). DURING THE PROCEDURE, A NON-ABBOTT. INTRODUCER SHEATH (65CM) WAS DELIVERED INTO THE AORTIC ARCH SINCE THE AORTA WAS HEAVILY CALCIFIED. THERE WAS DIFFICULTY WIRING AT THE LEFT VENTRICLE. IT WAS ATTEMPTED 3 TIMES, AND IT WAS SUCCEEDED. A PRE-BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH A 16MM NON-ABBOTT BALLOON, WHICH DID NOT EXCEED THE MINIMUM AORTIC ANNULUS DIAMETER. THE VALVE WAS ABLE TO BE SUCCESSFULLY IMPLANTED AT A DEPTH OF 4MM. AFTER IMPLANT, MODERATE PARAVALVULAR LEAK (PVL) WAS NOTED AROUND THE VALVE AT THE LCC. A POST-BAV WAS DONE USING A 16MM NON-ABBOTT BALLOON, BUT THE CONDITION REMAINED THE SAME. FURTHER BAV WAS NOT PERFORMED CONSIDERING THE RISK OF RAPTURE. THE PATIENT LEFT THE OPERATING ROOM SINCE THE VITAL WAS STABLE (PULSE 130/ RESPIRATORY RATE: 45). A CT WAS PERFORMED AFTER LEAVING THE OPERATING ROOM, FOUND THAT THE PATIENT HAD A CEREBRAL INFARCTION, AND THE PATIENT WAS PARALYZED (UNABLE TO MOVE RIGHT SIDE OF HER ARM AND LEG). IT IS UNKNOWN WHERE THE CEREBRAL INFARCTION OCCURRED IN THE PATIENT. THERE WAS ALSO UNIDENTIFIED DEBRIS NOTED DEEP INTO THE PERIPHERAL AND WAS DIFFICULT TO REMOVE. NO BLOCKAGE WAS NOTED DUE TO THE DEBRIS. NO PROCEDURE WILL BE DONE TO REMOVE THE DEBRIS. THE PHYSICIAN BELIEVES THAT THE DEBRIS WAS "BLOWN AWAY" DURING THE PRE-BAV. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT IS CURRENTLY STABLE.
IT WAS REPORTED THAT ON 03 SEP. 2024, A 25MM NAVITOR VALVE WAS SELECTED FOR IMPLANT USING A SMALL FLEXNAV DELIVERY SYSTEM (DS). THE ANNULAR DIMENSIONS OF THE PATIENT WERE APPROXIMATELY 21MM (AVERAGE). DURING THE PROCEDURE, A NON-ABBOTT. INTRODUCER SHEATH (65CM) WAS DELIVERED INTO THE AORTIC ARCH SINCE THE AORTA WAS HEAVILY CALCIFIED. THERE WAS DIFFICULTY WIRING AT THE LEFT VENTRICLE. IT WAS ATTEMPTED 3 TIMES, AND IT WAS SUCCEEDED. A PRE-BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH A 16MM NON-ABBOTT BALLOON, WHICH DID NOT EXCEED THE MINIMUM AORTIC ANNULUS DIAMETER. THE VALVE WAS ABLE TO BE SUCCESSFULLY IMPLANTED AT A DEPTH OF 4MM. AFTER IMPLANT, MODERATE PARAVALVULAR LEAK (PVL) WAS NOTED AROUND THE VALVE AT THE LCC. A POST-BAV WAS DONE USING A 16MM NON-ABBOTT BALLOON, BUT THE CONDITION REMAINED THE SAME. FURTHER BAV WAS NOT PERFORMED CONSIDERING THE RISK OF RAPTURE. THE PATIENT LEFT THE OPERATING ROOM SINCE THE VITAL WAS STABLE (PULSE 130/ RESPIRATORY RATE: 45). A CT WAS PERFORMED AFTER LEAVING THE OPERATING ROOM, FOUND THAT THE PATIENT HAD A CEREBRAL INFARCTION, AND THE PATIENT WAS PARALYZED (UNABLE TO MOVE RIGHT SIDE OF HER ARM AND LEG). IT IS UNKNOWN WHERE THE CEREBRAL INFARCTION OCCURRED IN THE PATIENT. THERE WAS ALSO UNIDENTIFIED DEBRIS NOTED DEEP INTO THE PERIPHERAL AND WAS DIFFICULT TO REMOVE. NO BLOCKAGE WAS NOTED DUE TO THE DEBRIS. NO PROCEDURE WILL BE DONE TO REMOVE THE DEBRIS. THE PHYSICIAN BELIEVES THAT THE DEBRIS WAS "BLOWN AWAY" DURING THE PRE-BAV. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT IS CURRENTLY STABLE.
IT WAS REPORTED THAT ON (B)(6) 2024, A 25MM NAVITOR VALVE WAS SELECTED FOR IMPLANT USING A SMALL FLEXNAV DELIVERY SYSTEM (DS). THE ANNULAR DIMENSIONS OF THE PATIENT WERE APPROXIMATELY 21MM (AVERAGE). DURING THE PROCEDURE, A NON-ABBOTT. INTRODUCER SHEATH (65CM) WAS DELIVERED INTO THE AORTIC ARCH SINCE THE AORTA WAS HEAVILY CALCIFIED. THERE WAS DIFFICULTY WIRING AT THE LEFT VENTRICLE. IT WAS ATTEMPTED 3 TIMES, AND IT WAS SUCCEEDED. A PRE-BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH A 16MM NON-ABBOTT BALLOON, WHICH DID NOT EXCEED THE MINIMUM AORTIC ANNULUS DIAMETER. THE VALVE WAS ABLE TO BE SUCCESSFULLY IMPLANTED AT A DEPTH OF 4MM. AFTER IMPLANT, MODERATE PARAVALVULAR LEAK (PVL) WAS NOTED AROUND THE VALVE AT THE LCC. A POST-BAV WAS DONE USING A 16MM NON-ABBOTT BALLOON, BUT THE CONDITION REMAINED THE SAME. FURTHER BAV WAS NOT PERFORMED CONSIDERING THE RISK OF RAPTURE. THE PATIENT LEFT THE OPERATING ROOM SINCE THE VITAL WAS STABLE (PULSE 130/ RESPIRATORY RATE: 45). A CT WAS PERFORMED AFTER LEAVING THE OPERATING ROOM, FOUND THAT THE PATIENT HAD A CEREBRAL INFARCTION, AND THE PATIENT WAS PARALYZED (UNABLE TO MOVE RIGHT SIDE OF HER ARM AND LEG). IT IS UNKNOWN WHERE THE CEREBRAL INFARCTION OCCURRED IN THE PATIENT. THERE WAS ALSO UNIDENTIFIED DEBRIS NOTED DEEP INTO THE PERIPHERAL AND WAS DIFFICULT TO REMOVE. NO BLOCKAGE WAS NOTED DUE TO THE DEBRIS. NO PROCEDURE WILL BE DONE TO REMOVE THE DEBRIS. THE PHYSICIAN BELIEVES THAT THE DEBRIS WAS "BLOWN AWAY" DURING THE PRE-BAV. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT IS CURRENTLY STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1372911 | NAVITOR VISION | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED | NPT | ABBOTT MEDICAL | 10235497 | 05415067045782 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 93 YR | Female | Disability| R |