PERCEVAL SUTURELESS AORTIC HEART VALVE
Report
- Report Number
- 3004478276-2020-00129
- Event Type
- Injury
- Date Received
- March 3, 2020
- Date of Event
- February 4, 2020
- Report Date
- August 27, 2020
- Manufacturer
- LIVANOVA CANADA CORP
- Product Code
- LWR
- PMA / PMN Number
- P150011
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
THE DEVICE AND THE STENT FRAGMENT WERE RETURNED TO THE MANUFACTURER AND THEY WERE RECEIVED ON 09 MAR 2020. THE NITINOL STENT OF THE DEVICE IS MISSING TO A PORTION THAT IS CONSISTENT WITH THE RETURNED FRAGMENT. PANNUS HAS BEEN OBSERVED PARTIALLY AROUND THE IMPLANT DIAMETER (SKIRT). FURTHER INVESTIGATION ON THE DEVICE IS ONGOING. H3 OTHER TEXT : PENDING COMPLETION OF INVESTIGATION.
THE MANUFACTURING AND MATERIAL RECORDS FOR THE PERCEVAL HEART VALVE (INCLUDING A DEDICATED REVIEW OF THE NITINOL STENT), MODEL #ICV1209, S/N # (B)(6), AS THEY PERTAIN TO THE REPORTED EVENT, WERE RETRIEVED AND REVIEWED BY QUALITY ENGINEERING. THE RESULTS CONFIRMED THAT THIS VALVE SATISFIED ALL MATERIAL, VISUAL, AND PERFORMANCE STANDARDS REQUIRED FOR A (MODEL #ICV1209) PERCEVAL HEART VALVE AT THE TIME OF MANUFACTURE AND RELEASE. THE VISUAL INSPECTION PERFORMED ON THE RETURNED PROSTHESIS CONFIRMED THE ABSENCE OF PRE-EXISTING DEFECTS. THE SIMULATION PERFORMED, WITH A DEMO VALVE REPRODUCING THE ALTERED STRUCTURAL CONFIGURATION, DID NOT EVIDENCED BEHAVIOR SUGGESTING A POSSIBLE CAUSE OF SIGNIFICANT LEAKAGES BOTH CENTRAL/PERIVALVULAR. A DEEP ANALYSIS WAS CONDUCTED ON THE STENT (INCLUDING THE BODY AND FRAGMENT) BY MEANS OF THE OPTICAL MICROSCOPE AND SCANNING ELECTRON MICROSCOPE (SEM). THE ANALYSIS CARRIED OUT ON THE SURFACE OF EACH FRACTURE SHOWED THE ABSENCE OF NITINOL TUBE DEFECTS AND/OR MANUFACTURING DEFECTS. THE INSPECTION AROUND BOTH THE STENT BODY AND THE STENT FRAGMENT FOUND SEVERAL AREAS WITH ALTERATIONS / DEFORMATION / SCRATCHES, AMONG WHICH THE PRESENCE OF IRON (FE) IN VARIOUS AREAS OF THE STENT. BASED ON LIVANOVA MANUFACTURING PROCESS (AS REVIEWED AND VERIFIED IN THE ANALYSIS OF PRODUCTION RECORDS), METAL TOOLS HAD BEEN USED NEITHER DURING THE PRODUCTION PROCESSES NOR DURING THE INVESTIGATION PHASES. AS SUCH, THE PRESENCE OF IRON CAN BE REASONABLY ASSOCIATED WITH THE CONTACT WITH SURGICAL TOOLS. BASED ON THE MORPHOLOGY OF THE IRON TRACES DETECTED AND THEIR POSITION, THE ANALYSIS PERFORMED REASONABLY SUGGESTS A CONTACT THAT OCCURRED DURING THE IMPLANTATION PROCESS WHEN THE STRUCTURE WAS STILL INTACT, RATHER THAN TO A CONTACT OCCURRED AT THE TIME OF EXPLANT. BASED ON THE PERFORMED ANALYSIS, THERE IS NO EVIDENCE SUGGESTING A MANUFACTURING DEFICIT WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. AS CONFIRMED BY THE RESULTS OF THE INVESTIGATION, A POSSIBLE MISHANDLING THAT OCCURRED AT THE TIME OF IMPLANT IS SUGGESTED. THEREFORE, THE MOST REASONABLE ROOT CAUSE OF THE REPORTED EVENT IS ATTRIBUTED TO AN UNINTENDED USE ERROR WHICH CAUSED OR CONTRIBUTED TO THE EVENT. SHOULD ADDITIONAL INFORMATION BE PROVIDED, THE MANUFACTURER WILL RE-ASSESS THE EVENT AS APPLICABLE AND PROVIDE A FOLLOW UP REPORT WITHIN THE REQUIRED TIMELINES.
BASED ON THE AVAILABLE INFORMATION, IT IS NOT POSSIBLE TO ESTABLISH A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT. HOWEVER, BASED ON THE INVESTIGATION PERFORMED, NO EVIDENCE OF A PRE-EXISTING MALFUNCTION OF THE DEVICE WAS IDENTIFIED.
ON (B)(6) 2019, A PATIENT RECEIVED A PERCEVAL PVS23 IN AORTIC POSITION. BOTH THE INTRAOPERATIVE ECHO AND THE PRE-DISCHARGE ECHO CONFIRMED A GOOD POSITIONING OF THE DEVICE, WITH GOOD FUNCTIONALITY AND NO PERIVALVULAR LEAK (PVL). THE PATIENT PRESENTED TO THE HOSPITAL ON (B)(6) 2020 WITH ACUTE CONGESTIVE HEART FAILURE (CFH) EXACERBATION AND ABNORMAL CHEST X-RAY (CRX). THE PATIENT HAD DEVELOPED SHORTNESS OF BREATH 3 WEEKS BEFORE BEING ADMITTED TO THE HOSPITAL, AND WAS FOUND TO HAVE BILATERAL PULMONARY INFILTRATES. AFTER DETAILED IMAGING, IT WAS FOUND THAT PART OF THE OUTFLOW STENT RING AND SINUSOIDAL STRUT HAD DISCONNECTED FROM THE REST OF THE VALVE AND WAS LODGED IN THE PATIENT'S RIGHT COMMON ILIAC ARTERY, WHERE IT WAS NOT CAUSING ANY FLOW OBSTRUCTIONS. THE ECHO AND CTA SHOWED SEVERE PERIVALVULAR LEAK (PVL). ON (B)(6) 2020, A RE-DO AORTIC VALVE REPLACEMENT (AVR) WAS PERFORMED. THE PATIENT RECEIVED AN INSPIRIS VALVE SIZE 25 AND IS DOING WELL AFTER SURGERY. THE FOREIGN BODY EXCISION WAS PERFORMED ON (B)(6) 2020.
ADDITIONAL INFORMATION RECEIVED FROM THE SITE CONFIRMED THAT NO MANIPULATION OF THE STENT AT THE TIME OF IMPLANT WERE PERFORMED, BASED ALSO IN THE REVIEWED OF THE VIDEO OF THE SURGERY. A POSSIBLE VALVE MISHANDLING WAS EXCLUDED. THE REMAINDER OF THE INFORMATION PREVIOUSLY SUBMITTED REMAINS UNCHANGED.
A COMPLETE MANUFACTURING AND MATERIAL RECORDS REVIEW FOR THE NITINOL STENT COMPONENT HAS BEEN PERFORMED. THE RESULTS CONFIRMED THAT THE COMPONENT SATISFIED ALL MATERIAL, VISUAL AND PERFORMANCE STANDARDS REQUIRED AT THE TIME OF MANUFACTURE AND RELEASE. FURTHER INVESTIGATION WILL BE PERFORMED UPON DEVICE RECEIPT.
ON 26 JUN 2019, A PATIENT RECEIVED A PERCEVAL PVS23 IN AORTIC POSITION. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH (EXACT TIMELINE UNKNOWN) AND, AFTER DETAILED IMAGING, IT WAS DISCOVERED THAT PART OF THE OUTFLOW RING AND SINUSOIDAL STRUT HAD DISCONNECTED FROM THE REST OF THE VALVE AND WAS LODGED IN THE PATIENT'S LEG. THE PATIENT ALSO HAD A SEVERE PERIVALVULAR LEAK AND NEEDED TO GO THROUGH RE-OPERATION, WHICH WAS PERFORMED ON 05 FEB 2020. THE PATIENT RECEIVED AN INSPIRIS VALVE SIZE 25 AND IS DOING WELL AFTER SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 243615 | PERCEVAL SUTURELESS AORTIC HEART VALVE | TISSUE HEART VALVES | LWR | LIVANOVA CANADA CORP | PVS23 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |