PERCEVAL SUTURELESS AORTIC HEART VALVE
Report
- Report Number
- 3004478276-2019-00136
- Event Type
- Injury
- Date Received
- March 19, 2019
- Date of Event
- February 18, 2019
- Report Date
- June 11, 2019
- Manufacturer
- LIVANOVA CANADA CORP
- Product Code
- LWR
- UDI-DI
- 00896208000443
- PMA / PMN Number
- P150011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
THE MANUFACTURING AND MATERIAL RECORDS FOR THE PERCEVAL HEART VALVE, MODEL #ICV1211 , S/N # (B)(6), AS THEY PERTAIN TO THE REPORTED EVENT, WERE RETRIEVED AND REVIEWED BY QUALITY ENGINEERING AT LIVANOVA CANADA CORP. THE RESULTS CONFIRMED THAT THIS VALVE SATISFIED ALL MATERIAL, VISUAL, AND PERFORMANCE STANDARDS REQUIRED FOR A (MODEL #ICV1211) PERCEVAL HEART VALVE AT THE TIME OF MANUFACTURE AND RELEASE. THE MANUFACTURER ATTEMPTED TO FOLLOW UP WITH THE SITE FOR ADDITIONAL INFORMATION; HOWEVER, NO FURTHER INFORMATION WAS RECEIVED. AS THE DEVICE WAS NOT RECEIVED FOR ANALYSIS, NO DEVICE INVESTIGATION CAN BE PERFORMED, AND THE ROOT CAUSE OF THE EVENT CANNOT BE DEDUCED FROM THE LIMITED INFORMATION PROVIDED. HOWEVER, BASED ON THE DOCUMENT REVIEW PERFORMED, NO MANUFACTURING DEFICIENCY WAS IDENTIFIED. IT SHOULD BE NOTED THAT THROMBOSIS IS LISTED IN THE PERCEVAL INSTRUCTIONS FOR USE AMONG THE POSSIBLE ADVERSE EVENTS ASSOCIATED WITH AORTIC VALVE REPLACEMENT WITH A BIOPROSTHESIS. AS SUCH, THE REPORTED EVENT IS A KNOWN INHERENT RISK OF THE DEVICE.
ALTHOUGH THE SITE COULD NOT CONFIRM OR EXCLUDE THE EVENT TYPE, THE INFORMATION AVAILABLE FROM THE OPERATION REPORT SUGGESTS THAT THIS WAS A CASE OF VALVE THROMBOSIS. BASED ON THE REPORTED SIZE OF THE PATIENT'S ANNULUS, VALVE MIS-SIZING IS NOT SUSPECTED. THE CONCLUSIONS SUBMITTED IN THE PREVIOUS REPORT ARE NOT AFFECTED BY THE ADDITIONAL INFORMATION RECEIVED. DEVICE NOT AVAILABLE FOR RETURN.
A PERCEVAL PVS27 WAS IMPLANTED ON (B)(6) 2017. AT DISCHARGE, THE PATIENT'S GRADIENT WAS 13 MMHG WITH TRACE PARAVALVULAR LEAK. IN (B)(6) 2018, THE GRADIENT WAS 20 MMHG AND MILD PARAVALVULAR LEAK WAS REPORTED. AT 1 YEAR FOLLOW-UP IN NOVEMBER 2018, THE REPORTED GRADIENT WAS 33 MMHG WITH PARAVALVULAR LEAK 1+ AND CENTRAL LEAK 2+. ON (B)(6) 2019, STRUCTURAL VALVE DETERIORATION RESULTING IN HIGH GRADE AORTIC STENOSIS WITH A LOW DEGREE OF INSUFFICIENCY WAS IDENTIFIED. THE PERCEVAL VALVE WAS EXPLANTED ON (B)(6) 2019 AND REPLACED WITH AN EDWARDS PERIMOUNT 25 MM VALVE. AT THE TIME OF RE-OPERATION, IT WAS REPORTED THAT THE AORTIC WALL WAS NORMAL AND NOT CALCIFIED. THE PERCEVAL VALVE WAS FOUND TO HAVE THROMBOTIC DEPOSITION ON ALL LEAFLETS, WHICH RESULTED IN RESTRICTION OF THE LEAFLET MOTION. FOLLOWING IMPLANT OF THE PERIMOUNT VALVE, INTRA-OPERATIVE TEE SHOWED GOOD VALVE FUNCTIONALITY WITH NO EVIDENCE OF PARAVALVULAR LEAK. THE PATIENT'S RISK FACTORS INCLUDED HYPERLIPIDEMIA AND TOBACCO USE. IT SHOULD BE NOTED THAT THE EVENT WAS CLASSIFIED AS "STRUCTURAL VALVE DETERIORATION" BY THE SITE; HOWEVER, THE DETAILS IN THE OPERATION REPORT SUGGEST THROMBOSIS AS THE PRIMARY MODE OF FAILURE.
A PERCEVAL PVS27 WAS IMPLANTED ON (B)(6) 2017 IN A PATIENT WITH AN ANNULUS MEASUREMENT OF 25 MM. AT DISCHARGE, THE PATIENT'S GRADIENT WAS 13 MMHG WITH TRACE PARAVALVULAR LEAK. IN (B)(6) 2018, THE GRADIENT WAS 20 MMHG AND MILD PARAVALVULAR LEAK WAS REPORTED. AT 1 YEAR FOLLOW-UP IN (B)(6) 2018, THE REPORTED GRADIENT WAS 33 MMHG WITH PARAVALVULAR LEAK 1+ AND CENTRAL LEAK 2+. ON (B)(6) 2019, STRUCTURAL VALVE DETERIORATION RESULTING IN HIGH GRADE AORTIC STENOSIS WITH A LOW DEGREE OF INSUFFICIENCY WAS REPORTED. THE PERCEVAL VALVE WAS EXPLANTED ON (B)(6) 2019 AND REPLACED WITH AN EDWARDS PERIMOUNT 25 MM VALVE. AT THE TIME OF RE-OPERATION, IT WAS STATED IN THE OPERATION REPORT THAT THE AORTIC WALL WAS NORMAL AND NOT CALCIFIED. THE PERCEVAL VALVE WAS FOUND TO HAVE THROMBOTIC DEPOSITION ON ALL LEAFLETS, WHICH RESULTED IN RESTRICTION OF THE LEAFLET MOTION. FOLLOWING IMPLANT OF THE PERIMOUNT VALVE, INTRA-OPERATIVE TEE SHOWED GOOD VALVE FUNCTIONALITY WITH NO EVIDENCE OF PARAVALVULAR LEAK. THE PATIENT'S RISK FACTORS INCLUDED HYPERLIPIDEMIA AND TOBACCO USE. ACCORDING TO THE SITE, THERE WAS NO EVIDENCE OF ENDOCARDITIS, AND THE PATIENT HAD NO KNOWN COAGULATION DISORDERS. IT SHOULD BE NOTED THAT THE EVENT WAS CLASSIFIED AS "STRUCTURAL VALVE DETERIORATION" BY THE SITE; HOWEVER, THE DETAILS IN THE OPERATION REPORT SUGGEST THROMBOSIS AS THE PRIMARY MODE OF FAILURE. UPON FOLLOW-UP WITH THE SITE, THE SITE COULD NOT CONFIRM WHETHER OR NOT THE EVENT WAS ATTRIBUTABLE TO THROMBOSIS.
DEVICE EVALUATED BY MFR: DEVICE DISPOSITION NOT PRESENTLY KNOWN.
A PERCEVAL PVS27 WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2019, STRUCTURAL VALVE DETERIORATION RESULTING IN HIGH GRADE AORTIC STENOSIS WITH A LOW DEGREE OF INSUFFICIENCY WAS IDENTIFIED. THE PERCEVAL VALVE WAS EXPLANTED AND REPLACED WITH AN EDWARDS PERIMOUNT 25 MM VALVE. AT THE TIME OF RE-OPERATION, IT WAS REPORTED THAT THE AORTIC WALL WAS NORMAL AND NOT CALCIFIED. THE PERCEVAL VALVE WAS FOUND TO HAVE THROMBOTIC DEPOSITION ON ALL LEAFLETS, WHICH RESULTED IN RESTRICTION OF THE LEAFLET MOTION. FOLLOWING IMPLANT OF THE PERIMOUNT VALVE, INTRA-OPERATIVE TEE SHOWED GOOD VALVE FUNCTIONALITY WITH NO EVIDENCE OF PARAVALVULAR LEAK. THE PATIENT'S RISK FACTORS INCLUDED HYPERLIPIDEMIA AND TOBACCO USE. IT SHOULD BE NOTED THAT THE EVENT WAS CLASSIFIED AS "STRUCTURAL VALVE DETERIORATION" BY THE SITE; HOWEVER, THE DETAILS IN THE OPERATION REPORT SUGGEST THROMBOSIS AS THE PRIMARY MODE OF FAILURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 226483 | PERCEVAL SUTURELESS AORTIC HEART VALVE | TISSUE HEART VALVE | LWR | LIVANOVA CANADA CORP | PVS27 | 00896208000443 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |