EVOLUT FX VALVE

Report

Report Number: 2025587-2024-03963
Event Type: Death
Date Received: July 15, 2024
Date of Event: July 10, 2024
Report Date: July 29, 2024
Manufacturer: MEDTRONIC HEART VALVES DIVISION
Product Code: NPT
UDI-DI: 00763000370701
PMA / PMN Number: P130021
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

CONTINUATION OF D10: PRODUCT ID: D-EVOLUTFX-2329, PRODUCT LOT/SERIAL NUMBER: UNKNOWN, PRODUCT TYPE: 0195-HEART VALVES. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Additional Manufacturer Narrative · 0

UPDATED DATA: H6. METHOD CODE UPDATED ADDITIONAL CODES ADDED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Additional Manufacturer Narrative · 0

UPDATED DATA: B5. SECOND PARAGRAPH ADDED H6. DEVICE CODE ADDED CORRECTED DATA: H6. PATIENT CODE ADDED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem · 0

MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE IN A PATIENT WITH A TYPE 0 BICUSPID VALVE AND CALCIFIED ANATOMY, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH A 20 MM NON-MEDTRONIC BALLOON, BUT WAS UNDER EXPANDED. A SECOND BAV WAS PERFORMED WITH A 23 MM BALLOON AND EXPANDED WELL; HOWEVER, THE PATIENT EXPERIENCED MODERATE TO SEVERE AORTIC INSUFFICIENCY. SUBSEQUENTLY, THE VALVE WAS DEPLOYED WITH DIFFICULTY VISUALIZING THE NON-CORONARY CUSP (NCC). UPON POWER INJECTION OF CONTRAST, THE VALVE APPEARED TO BE BELOW THE NCC AND LEFT CORONARY CUSP (LCC). THE FLUOROSCOPIC VIEW WAS SWITCHED TO THE LEFT ANTERIOR OBLIQUE ANGLE TO CONFIRM. AS THE PATIENT'S BLOOD PRESSURE WAS DROPPING, THE VALVE WAS FULLY DEPLOYED AND APPEARED EXPANDED, BUT MODERATE-SEVERE REGURGITATION REMAINED. A POST-IMPLANT BAV WAS PERFORMED TO FULLY EXPAND THE VALVE USING A 23 MM NON-MEDTRONIC BALLOON, AND THE VALVE WAS WELL EXPANDED. THE PATIENT'S SYSTOLIC BLOOD PRESSURE IMPROVED TO 70-80 MMHG. AN ECHOCARDIOGRAM SHOWED THE VALVE APPEARED TO BE AT A DEPTH OF 0 MM OR 1 MM ON BOTH THE LCC AND NCC. THE MODERATE-SEVERE REGURGITATION REMAINED PRESENT, BUT THE PATIENT WAS STABLE AND WAS TRANSFERRED TO THE OPERATING ROOM FOR A SURGICAL AORTIC VALVE REPLACEMENT AND AORTIC REPAIR; HOWEVER, IT WAS REPORTED THAT THE PATIENT DID NOT COME OFF THE PUMP AND SUBSEQUENTLY DIED.

Description of Event or Problem · 0

MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE IN A PATIENT WITH A TYPE 0 BICUSPID VALVE AND CALCIFIED ANATOMY, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH A 20 MM NON-MEDTRONIC BALLOON, BUT WAS UNDER EXPANDED. A SECOND BAV WAS PERFORMED WITH A 23 MM BALLOON AND EXPANDED WELL; HOWEVER, THE PATIENT EXPERIENCED MODERATE TO SEVERE AORTIC INSUFFICIENCY. SUBSEQUENTLY, THE VALVE WAS DEPLOYED WITH DIFFICULTY VISUALIZING THE NON-CORONARY CUSP (NCC). UPON POWER INJECTION OF CONTRAST, THE VALVE APPEARED TO BE BELOW THE NCC AND LEFT CORONARY CUSP (LCC). THE FLUOROSCOPIC VIEW WAS SWITCHED TO THE LEFT ANTERIOR OBLIQUE ANGLE TO CONFIRM. AS THE PATIENT'S BLOOD PRESSURE WAS DROPPING, THE VALVE WAS FULLY DEPLOYED AND APPEARED EXPANDED, BUT MODERATE-SEVERE REGURGITATION REMAINED. A POST-IMPLANT BAV WAS PERFORMED TO FULLY EXPAND THE VALVE USING A 23 MM NON-MEDTRONIC BALLOON, AND THE VALVE WAS WELL EXPANDED. THE PATIENT'S SYSTOLIC BLOOD PRESSURE IMPROVED TO 70-80 MMHG. AN ECHOCARDIOGRAM SHOWED THE VALVE APPEARED TO BE AT A DEPTH OF 0 MM OR 1 MM ON BOTH THE LCC AND NCC. THE MODERATE-SEVERE REGURGITATION REMAINED PRESENT, BUT THE PATIENT WAS STABLE AND WAS TRANSFERRED TO THE OPERATING ROOM FOR A SURGICAL AORTIC VALVE REPLACEMENT AND AORTIC REPAIR; HOWEVER, IT WAS REPORTED THAT THE PATIENT DID NOT COME OFF THE PUMP AND SUBSEQUENTLY DIED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SEVERE REGURGITATION NOTED AFTER VALVE IMPLANT WAS PARAVALVULAR LEAK.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
256697	EVOLUT FX VALVE	AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV	NPT	MEDTRONIC HEART VALVES DIVISION	EVOLUTFX-29		00763000370701

Patients

Seq	Age	Sex	Outcome	Treatment
1	70 YR	Male	Death