PERCEVAL SUTURELESS AORTIC HEART VALVE
Report
- Report Number
- 1718850-2020-01212
- Event Type
- Injury
- Date Received
- December 9, 2020
- Date of Event
- November 11, 2020
- Report Date
- April 8, 2021
- Manufacturer
- LIVANOVA CANADA CORP.
- Product Code
- LWR
- UDI-DI
- 00896208000412
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
FIELDS UPDATED: B4, D9, F6, F7, F10. THE DEVICE INVOLVED IN THE REPORTED EVENT WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. AFTER DECONTAMINATION, THE VALVE WAS VISUALLY INSPECTED WITHOUT HIGHLIGHTING ANY PARTICULAR ELEMENT OF NON-CONFORMITY THAT COULD BE RELATED TO POSSIBLE PRE-EXISTING DEFECTS. THE DIMENSIONAL ANALYSIS PERFORMED ON THE RETURNED PROSTHESIS CONFIRMING THE CORRECT DIMENSIONS DEVICE. IN ORDER TO ALLOW AN EXHAUSTIVE EVALUATION OF THE FUNCTIONAL BEHAVIOR, A SIMULATION OF COLLAPSING, DEPLOYMENT AND BALLOONING PHASES WAS PERFORMED TO ATTEMPT TO REPLICATE THE REPORTED EVENT. THE COLLAPSING PROCEDURE PERFORMED WITH THE RETURNED VALVE AND A DEMO ACCESSORY KIT WAS COMPLETED WITH NO ISSUE. THE VALVE WAS CORRECTLY COLLAPSED. DURING THE SIMULATION OF THE VALVE DEPLOYMENT IN SILICON AORTIC ROOT NO. 21, NO PROBLEMS WERE ENCOUNTERED DURING THE BALLOONING PHASE. THE SEALING AT THE ANNULUS LEVEL IS GUARANTEED AND THE VALVE REMAINED FIXED WITHIN THE ANNULUS. THEN, INSERTING SOME WATER IN THE AORTIC ROOTS FROM THE OUTFLOW SIDE, NO PARAVALVULAR LEAKS WERE OBSERVED DURING BOTH THE SIMULATIONS, CONSIDERING THE STATIC CONDITIONS OF THE TEST. THE WATER LEVEL REMAINED STABLE UNDER THE LEAFLETS FREE EDGE. BASED ON THE PERFORMED ANALYSIS, IT IS POSSIBLE TO EXCLUDE ANY RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED ISSUE. THE ROOT CAUSE OF THE PERCEVAL STENT FOLDING DETECTED AFTER THE IMPLANT CAN BE REASONABLY ATTRIBUTED TO AN INITIAL VALVE OVERSIZING, IN AGREEMENT WITH THE INFORMATION REPORTED FROM THE FIELD AND IN LINE WITH LIVANOVA¿S EXPERIENCE WITH STENT FOLDING EVENTS.
THE MANUFACTURER RECEIVED ADDITIONAL INFORMATION CONFIRMING THAT THE PHRASE ¿DILATION WAS PERFORMED", IT WAS A MISDESCRIPTION. THE DILATION WAS PERFORMED TO PERCEVAL, HOWEVER IT WAS NOT PERFORMED AFTER THE EXPLANT, BUT AFTER DEPLOYMENT. THIS HAS BEEN UPDATED IN THE EVENT DESCRIPTION (B5).
THE MANUFACTURING AND MATERIAL RECORDS FOR THE PERCEVAL HEART VALVE, MODEL #ICV1208, S/N # (B)(6), AS THEY PERTAIN TO THE REPORTED EVENT, WERE RETRIEVED AND REVIEWED BY QUALITY ENGINEERING AT LIVANOVA. THE RESULTS CONFIRMED THAT THIS VALVE SATISFIED ALL MATERIAL, VISUAL, AND PERFORMANCE STANDARDS REQUIRED FOR A (MODEL #ICV1208) PERCEVAL HEART VALVE AT THE TIME OF MANUFACTURE AND RELEASE. FURTHER INVESTIGATION WILL BE PERFORMED ONCE THE DEVICE WILL BE RECEIVED.
ON (B)(6) 2020, A PERCEVAL PVS 21 IMPLANT ATTEMPT OCCURRED AS PART OF AN AVR + TAP + MAZE PROCEDURE. AFTER TAP, MAZE AND SELF-VALVE REMOVAL, SIZING WAS PERFORMED USING A SIZER. ALTHOUGH THE S TRANSPARENT SIZER WAS INSERTED, THE S WHITE SIZER WAS NOT ABLE TO PASS THROUGH. AFTER THAT, THE CALCIFIED TISSUE WAS REMOVED WITH CUSA, AND IT WAS CONFIRMED THAT THE S WHITE SIZER WAS INSERTED SEVERAL TIMES, AND THE PERCEVAL S WAS IMPLANTED. AFTER DECLAMPING, TRANSESOPHAGEAL ECHO SHOWED VALVE CENTER REGURGITATION AND PVL (MODERATE). THE AORTA WAS RE-CLAMPED AND IT WAS CONFIRMED THAT THE STENT WAS INFOLDED AND SLIGHTLY RISING AT THE RCC POSITION. THE PERCEVAL PVS21 WAS EXPLANTED, BALLOONING OF THE PERCEVAL VALVE WAS PERFORMED, AND CROWN 19 MM WAS IMPLANTED TO COMPLETE THE PROCEDURE. NO INFORMATION IS AVAILABLE REGARDING IMPLANTED POSITION OF CROWN. EXTRACORPOREAL CIRCULATION TIME 204 MINUTES, CLAMP TIME 110 MINUTES + 49 MINUTES. THE PATIENT IS CURRENTLY STABLE AND IT WAS SAID THAT EXTUBATION WOULD BE DONE ON (B)(6). THE PATIENT REPORTEDLY HAD A SMALL ANNULUS. AS REPORTED, OVERSIZING OF THE PERCEVAL PVS21 WAS SUSPECTED. THE MANUFACTURER RECEIVED ADDITIONAL INFORMATION CONFIRMING THAT THE PHRASE ¿DILATION WAS PERFORMED", IT WAS A MISDESCRIPTION. THE DILATION WAS PERFORMED TO PERCEVAL, HOWEVER IT WAS NOT PERFORMED AFTER THE EXPLANT, BUT AFTER DEPLOYMENT.
ON (B)(6) 2020, A PERCEVAL PVS 21 IMPLANT ATTEMPT OCCURRED AS PART OF AN AVR + TAP + MAZE PROCEDURE. AFTER TAP, MAZE AND SELF-VALVE REMOVAL, SIZING WAS PERFORMED USING A SIZER. ALTHOUGH THE S TRANSPARENT SIZER WAS INSERTED, THE S WHITE SIZER WAS NOT ABLE TO PASS THROUGH. AFTER THAT, THE CALCIFIED TISSUE WAS REMOVED WITH CUSA, AND IT WAS CONFIRMED THAT THE S WHITE SIZER WAS INSERTED SEVERAL TIMES, AND THE PERCEVAL S WAS IMPLANTED. AFTER DECLAMPING, TRANSESOPHAGEAL ECHO SHOWED VALVE CENTER REGURGITATION AND PVL (MODERATE). THE AORTA WAS RE-CLAMPED AND IT WAS CONFIRMED THAT THE STENT WAS INFOLDED AND SLIGHTLY RISING AT THE RCC POSITION. THE PERCEVAL PVS21 WAS EXPLANTED, BALLOONING OF THE PERCEVAL VALVE WAS PERFORMED, AND CROWN 19 MM WAS IMPLANTED TO COMPLETE THE PROCEDURE. NO INFORMATION IS AVAILABLE REGARDING IMPLANTED POSITION OF CROWN. EXTRACORPOREAL CIRCULATION TIME 204 MINUTES, CLAMP TIME 110 MINUTES + 49 MINUTES. THE PATIENT IS CURRENTLY STABLE AND IT WAS SAID THAT EXTUBATION WOULD BE DONE ON NOVEMBER 12TH OR 13TH. THE PATIENT REPORTEDLY HAD A SMALL ANNULUS. AS REPORTED, OVERSIZING OF THE PERCEVAL PVS21 WAS SUSPECTED.
ON (B)(6) 2020, A PERCEVAL PVS 21 IMPLANT ATTEMPT OCCURRED AS PART OF AN AVR + TAP + MAZE PROCEDURE. AFTER TAP, MAZE AND SELF-VALVE REMOVAL, SIZING WAS PERFORMED USING A SIZER. ALTHOUGH THE S TRANSPARENT SIZER WAS INSERTED, THE S WHITE SIZER WAS NOT ABLE TO PASS THROUGH. AFTER THAT, THE CALCIFIED TISSUE WAS REMOVED WITH CUSA, AND IT WAS CONFIRMED THAT THE S WHITE SIZER WAS INSERTED SEVERAL TIMES, AND THE PERCEVAL S WAS IMPLANTED. AFTER DECLAMPING, TRANSESOPHAGEAL ECHO SHOWED VALVE CENTER REGURGITATION AND PVL (MODERATE). THE AORTA WAS RE-CLAMPED AND THE PERCEVAL PVS21 WAS EXPLANTED, DILATION WAS PERFORMED, AND CROWN 19 MM WAS IMPLANTED TO COMPLETE THE PROCEDURE. WHEN RE-BLOCKED, IT WAS CONFIRMED THAT THE STENT WAS INFOLDED AND SLIGHTLY RISING AT THE RCC POSITION. EXTRACORPOREAL CIRCULATION TIME 204 MINUTES, CLAMP TIME 110 MINUTES + 49 MINUTES. THE PATIENT IS CURRENTLY STABLE AND IT WAS SAID THAT EXTUBATION WOULD BE DONE ON (B)(6). THE PATIENT REPORTEDLY HAD A SMALL ANNULUS. AS REPORTED, OVERSIZING OF THE PERCEVAL PVS21 WAS SUSPECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1439169 | PERCEVAL SUTURELESS AORTIC HEART VALVE | TISSUE HEART VALVE | LWR | LIVANOVA CANADA CORP. | PVS21 | 00896208000412 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Required Intervention |