HAART 200 AORTIC ANNULOPLASTY RING
Report
- Report Number
- 3005687633-2025-00110
- Event Type
- Injury
- Date Received
- May 9, 2025
- Date of Event
- March 11, 2025
- Report Date
- September 1, 2025
- Manufacturer
- CORCYM INC.
- Product Code
- KRH
- UDI-DI
- 10857160006147
- PMA / PMN Number
- K171431
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HU
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
NOTE: THE DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS. FDA PREMARKET SUBMISSION NUMBER OF SIMILAR DEVICE: K171431 (SUPPLEMENT NUMBER 000 ); PRIMARY DI NUMBER FOR SIMILAR DEVICE: (B)(4). THE MANUFACTURING AND MATERIAL RECORDS FOR THE DEVICE INVOLVED IN THIS EVENT, AS THEY PERTAIN TO THE REPORTED ISSUE, WERE RETRIEVED AND REVIEWED BY THE MANUFACTURER¿S QUALITY ENGINEERING. THE RESULTS CONFIRMED THAT THIS DEVICE SATISFIED ALL REQUIRED MATERIAL, VISUAL, AND PERFORMANCE STANDARDS AT THE TIME OF MANUFACTURE AND RELEASE. THE MANUFACTURER WAS SIMULTANEOUSLY INFORMED OF FOUR REOPERATIONS INVOLVING PATIENTS IMPLANTED WITH HAART 200 DEVICES OCCURRED AT MILITARY HOSPITAL BUDAPEST. THE INCIDENTS SHARE THE SAME EVENT DESCRIPTION AND MEDICAL JUDGMENT. THE MANUFACTURER IS SUBMITTING A REPORT FOR EACH OF THE NOTIFIED EVENTS AND IS FOLLOWING UP WITH THE HEALTHCARE FACILITY TO RETRIEVE ADDITIONAL INFORMATION ON EACH EVENT AD THE DEVICES INVOLVED. A FOLLOW UP REPORT WILL BE SUBMITTED AT THE RECEIPT OF ANY NEW INFORMATION OR AT THE COMPLETION OF THE INVESTIGATION.
UPDATED SECTIONS: B3, B4, B5, D6A, D6B, G3, G6, H2, H6, H11. CORRECTED SECTIONS: G1. A COMPLETE MANUFACTURING AND MATERIAL RECORDS REVIEW FOR THE DEVICE OBJECT OF THE PRESENT DOCUMENT HAS BEEN PERFORMED. THE RESULTS CONFIRMED THAT THE DEVICE OBJECT OF THIS REVIEW SATISFIED ALL MATERIAL, VISUAL, AND PERFORMANCE SPECIFICATIONS REQUIRED AT THE TIME OF MANUFACTURE AND RELEASE. SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS, THE MANUFACTURER COULD NOT PERFORM ANY FURTHER DIRECT INVESTIGATION ON THE INVOLVED HAART RING. BASED ON THE AVAILABLE INFORMATION, IT IS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT. HOWEVER, IT IS REASONABLE TO ASSUME THAT THE EVENT LIKELY RESULTED FROM A COMBINATION OF CONTRIBUTING FACTORS. ACCORDING TO THE MANUFACTURER¿S EXPERIENCE, THE MOST RELEVANT FACTORS MAY INCLUDE UNEVEN SPACING OF THE SUTURES AND AN EXCESSIVELY HIGH POSITIONING OF THE RING, WHICH COULD HAVE LED TO CONTACT BETWEEN THE LEAFLETS AND THE DEVICE. ADDITIONALLY, THE POSSIBILITY THAT A LARGER RING SIZE MIGHT HAVE BEEN MORE APPROPRIATE CANNOT BE EXCLUDED. PATIENT-SPECIFIC FACTORS (E.G. TISSUE FRAGILITY) MAY ALSO HAVE PLAYED A ROLE. IT IS IMPORTANT TO NOTE THAT THE INSTRUCTIONS FOR USE (IFU) FOR THE HAART DEVICE RECOMMEND THE FOLLOWING PRECAUTIONS: TO PREVENT SUTURES FROM PULLING THROUGH THE NATIVE ANNULAR TISSUE, PLEDGETS SHOULD BE USED AS DESCRIBED IN THE IFU. A SUFFICIENT NUMBER OF BROAD HORIZONTAL MATTRESS SUTURES SHOULD BE APPLIED TO ELIMINATE GAPS BETWEEN THE DEVICE AND THE ANNULAR TISSUE AND TO SUPPORT THE TENSION ASSOCIATED WITH ANNULAR REDUCTION. IMPLANTATION SUTURES SHOULD BE PLACED DEEPLY TO ENSURE THAT THE HAART DEVICE IS POSITIONED AT LEAST 2 MM BELOW THE LEAFLET-AORTIC JUNCTION AND THE TOPS OF THE SUBCOMMISSURAL TRIANGLES, IN ORDER TO PREVENT CONTACT BETWEEN THE LEAFLETS AND THE DEVICE. IT IS POSSIBLE THAT PATIENT-SPECIFIC ANATOMICAL CONDITIONS MAY HAVE PREVENTED OPTIMAL POSITIONING OF THE DEVICE, ALTHOUGH THIS CANNOT ULTIMATELY BE CONFIRMED BASED ON THE AVAILABLE INFORMATION.
THE MANUFACTURER WAS INFORMED OF A REOPERATION PERFORMED ON A PATIENT IMPLANTED WITH A HAART 200 DEVICE. ACCORDING TO THE NOTIFICATION RECEIVED, WITHIN A COUPLE OF WEEKS FOLLOWING THE IMPLANTATION OF THE AORTIC RING, THE PATIENT EXHIBITED INCREASED INSUFFICIENCY AND A DECLINE IN GRADIENT PERFORMANCE. DURING REOPERATION, A LEAFLET TEAR WAS OBSERVED AT THE LEVEL OF THE FUSED CUSPS. MEDICAL JUDGMENT SUGGESTS THAT THE PRIMARY CAUSE OF THE FAILURE IS LIKELY DUE TO THE INABILITY TO SECURE A STITCH IN THE FUSED COMMISSURE, AS INDICATED IN THE DEVICE'S IFU. THE MANUFACTURER IS FOLLOWING UP WITH THE HEALTHCARE FACILITY TO RETRIEVE ADDITIONAL DETAILS ON THE EVENT AND THE DEVICE INVOLVED.
THE MANUFACTURER WAS INFORMED OF A REOPERATION PERFORMED ON A PATIENT IMPLANTED WITH HAART 200 DEVICE. ACCORDING TO THE NOTIFICATION RECEIVED, THE PATIENT UNDERWENT AORTIC VALVULOPLASTY THROUGH PARTIAL STERNOTOMY ON (B)(6) 2024. PRE-OPERATIVE TRANSTHORACIC ECHOCARDIOGRAPHIC EXAMINATION SHOWED A BICUSPID AORTIC VALVE WITH SEVERE AORTIC INSUFFICIENCY, LEFT VENTRICLE WITH WIDER CAVITY SIZE, NORMAL WALL THICKNESS, GOOD SYSTOLIC FUNCTION, ATRIA OF NORMAL DIMENSIONS, A RIGHT VENTRICLE WITH NORMAL DIMENSIONS AND GOOD LONGITUDINAL CONTRACTION, MILD SECONDARY MITRAL INSUFFICIENCY, TRICUSPID INSUFFICIENCY, NO SEGMENTAL WALL MOTION DISORDERS. THE AORTIC INSUFFICIENCY WAS REPORTED TO BE GRADE III/III WITH CENTRALLY ORIGINATING ECCENTRIC JET RUNNING TOWARDS THE MITRAL ANTERIOR LEAFLET. AFTER SIZING, A HAART 200 21MM AORTIC RING WAS IMPLANTED IN THE SUB ANNULAR POSITION. AS REPORTED, THE PROLAPSING NON-CORONARY LEAFLET WAS PLICATED WITH 6/0 KNOTTED PROLENE SUTURES. THE FUSED RIGHT AND LEFT LEAFLETS WERE ARE ALSO PLICATED WITH 6 STITCHES. INTRA-OPERATIVE TEE CONFIRMED NO AORTIC INSUFFICIENCY, GOOD COAPTATION, GOOD RECONSTRUCTION AND 10 MMHG AVERAGE GRADIENT WAS MEASURED. AT THE EARLY POST-OPERATIVE TRANSTHORACIC ECHOCARDIOGRAPHY, MILD GRADE AORTIC INSUFFICIENCY WAS DETECTED, THE LEFT VENTRICLE SHOWED A WIDER CAVITY SIZE, NORMAL WALL THICKNESS, GOOD SYSTOLIC FUNCTION. ATRIA AND RIGHT VENTRICLE WERE CONFIRMED TO BE OF NORMAL DIMENSIONS. THE RIGHT VENTRICLE SHOWED A SLIGHTLY REDUCED LONGITUDINAL CONTRACTION. MILD SECONDARY MITRAL INSUFFICIENCY AND TRICUSPID INSUFFICIENCY WERE DETECTED. THE PULMONARY PRESSURE WAS NORMAL AND NO SEGMENTAL WALL MOTION DISORDER WAS VISUALIZED. AT THE ECHOCARDIOGRAPHIC FOLLOW-UP PERFORMED ON (B)(6) 2025, SEVERE AORTIC VALVE REGURGITATION WAS DETECTED. MILD SECONDARY MITRAL AND TRICUSPID INSUFFICIENCY WERE ALSO DETECTED. THE LEFT VENTRICLE WAS FOUND WITH WIDE CAVITY SIZE, NORMAL WALL THICKNESS, GOOD SYSTOLIC FUNCTION. LEFT ATRIUM WAS ENLARGED. THE RIGHT VENTRICLE WAS OF NORMAL DIMENSIONS, WITH GOOD LONGITUDINAL CONTRACTION. NO SEGMENTAL WALL MOTION DISORDER WAS VISUALIZED. BASED ON THESE FINDINGS, THE PATIENT UNDERWENT RE-DO SURGERY ON (B)(6) 2025. REPORTEDLY, A HUGE PERFORATION WAS VISIBLE ALONG THE FUSED AND PREVIOUSLY STICHED RIGHT AND LEFT LEAFLETS ALONG THE PLANE OF THE ANNULUS, WHICH WAS CAUSING THE INSUFFICIENCY. THE HAART 200 RING WAS THEREFORE REMOVED TOGETHER WITH THE TEFLON SUTURES, WHICH HAD ALREADY BECOME ENDOTHELIALIZED SINCE THE PREVIOUS SURGERY. THE RING WAS EXPLANTED WITHOUT REPORTED DIFFICULTIES AND A 25 MM SORIN MECHANICAL PROSTHETIC VALVE WAS IMPLANTED INSTEAD. NO VEGETATIONS WERE VISIBLE ON THE HAART DEVICE. THE POST-OPERATIVE TRANSTHORACIC ECHOCARDIOGRAPHY CONFIRMED A GOOD FUNCTIONALITY OF THE REPLACEMENT PROSTHESIS. MEDICAL JUDGMENT SUGGESTS THAT THE PRIMARY CAUSE OF THE FAILURE IS LIKELY DUE TO THE INABILITY TO SECURE A STITCH IN THE FUSED COMMISSURE, AS INDICATED IN THE DEVICE'S IFU.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1969111 | HAART 200 AORTIC ANNULOPLASTY RING | AORTIC ANNULOPLASTY RING | KRH | CORCYM INC. | HAART 200-21 | 01-01097 | 10857160006147 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |