HAART 200 AORTIC ANNULOPLASTY RING
Report
- Report Number
- 3005687633-2025-00108
- Event Type
- Injury
- Date Received
- May 9, 2025
- Date of Event
- June 18, 2025
- Report Date
- October 16, 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
UPDATED SECTIONS: A2, B3, B4, B5, D6A, D6B, G3, G6, H2, H4, H6, H11. CORRECTED SECTIONS: B5, G1, H4 NOTE ON CORRECTION IN SECTION B5: AT THE TIME OF INITIAL REPORT SUBMISSION THE PATIENT WAS STILL UNDER MONITORING; REOPERATION HAS BEEN PERFORMED ON (B)(6) 2025 ACCORDING TO THE NEW INFORMATION RECEIVED. 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.
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: B4, G3, G6, H2, H11. CORRECTED SECTION: B5. THE MANUFACTURER CONDUCTED FURTHER FOLLOW-UP WITH THE IMPLANTING SURGEON AFTER IDENTIFYING AN INCONSISTENCY IN THE INFORMATION REPORTED REGARDING THE FUNCTIONALITY OF THE MECHANICAL VALVE IMPLANTED IN THE PATIENT. SPECIFICALLY, ALTHOUGH THE ECHOCARDIOGRAPHIC FOLLOW-UP PERFORMED ON (B)(6) 2025 INDICATED THAT THE PROSTHESIS WAS FUNCTIONING WELL, IT ALSO NOTED MILD AORTIC INSUFFICIENCY. BASED ON THE INFORMATION RECEIVED, THIS INSUFFICIENCY¿LATER REASSESSED AS TRIVIAL¿WAS ACTUALLY DUE TO THE MECHANICAL VALVE¿S WASHING JET AND HAD BEEN MISINTERPRETED IN THE ECHOCARDIOGRAPHIC REPORT.
THE MANUFACTURER HAS BEEN NOTIFIED OF A CASE OF RECURRENT AI INVOLVING A PATIENT TREATED WITH A HAART 200 DEVICE. REPORTEDLY, THE PATIENT UNDERWENT AORTIC VALVULOPLASTY DUE TO FUNCTIONAL BICUSPID AORTIC VALVE ON (B)(6) 2024 THROUGH PARTIAL STERNOTOMY. PRE-OPERATIVE ECHOCARDIOGRAPHIC EXAMINATION SHOWED A LEFT VENTRICLE WITH SLIGHTLY LARGER CAVITY SIZE, SEPTALLY HYPERTROPHIC WALL THICKNESS, GOOD SYSTOLIC FUNCTION, NORMAL ATRIA DIMENSIONS AND NORMAL RIGHT VENTRICLE DIMENSIONS WITH GOOD LONGITUDINAL CONTRACTION, SEVERE ORGANIC AORTIC INSUFFICIENCY, MILD SECONDARY MITRAL AND TRICUSPID REGURGITATION. BASED ON THE INFORMATION RECEIVED, AFTER PERFORMING THE SIZING PROCEDURE A SIZE 21 RING WAS SELECTED AND IMPLANTED IN SUB ANNULAR POSITION. THE REPAIR WAS COMPLETED BY PLICATING THE NON-CORONARY LEAFLET WITH 6/0 KNOTTED PROLENE SUTURES AND THE FUSED LEFT-RIGHT LEAFLET WITH 6 STICHES, ACHIEVING A GOOD COAPTATION. THE EARLY POST-OPERATIVE TRANSTHORACIC ECHOCARDIOGRAPHY CONFIRMED THE SUCCESSFULL CORRECTION OF THE AORTIC INSUFFICIENCY, HOWEVER AN INCREASED GRADIENT WAS DETECTED (GRADE 1 STENOSIS). AT AN ECHOCARDIOGRAPHIC FOLLOW-UP PERFORMED ON (B)(6) 2025, RECURRENT PROLAPSE WITH PROGRESSIVE, SIGNIFICANT RECURRENT AI AND INCREASED GRADIENT VALUES WERE DETECTED. IN ADDITION, BILLOWING MITRAL ANTERIOR AND TRICUSPID LEAFLETS WERE NOTED, LEADING TO MITRAL AND MILD TRICUSPID INSUFFICIENCY. AS SUCH, THE INDICATION FOR REOPERATION WAS POSED AND RE-DO SURGERY WAS PERFORMED ON 1(B)(6) 2025. BASED ON THE INFORMATION RECEIVED, A PERFORATION ALONG THE ANNULAR PLANE AT THE FUSED AND PREVIOUSLY SUTURED RIGHT-LEFT CORONARY CUSP, WAS IDENTIFIED INTRA-OPERATIVELY RESULTING IN VALVULAR INSUFFICIENCY. THE RING, ALONG WITH THE ASSOCIATED TEFLON SUTURES¿WHICH HAD UNDERGONE ENDOTHELIALIZATION SINCE THE PRIOR INTERVENTION¿WAS EXPLANTED WITHOUT RESISTANCE AND THE SMALL HOLE COMMUNICATING WITH THE LEFT ATRIUM IN THE AORTIC OUTFLOW TRACT WAS CLOSED WITH 5/0 SUTURE. NO VEGETATIONS WERE OBSERVED ON THE EXPLANTED RING. REPORTEDLY, THE SURGERY WAS COMPLETED BY IMPLANTING A BICARBON SLIMLINE 25 MM (SN (B)(6)) AORTIC MECHANICAL PROSTHESIS WITH NO REPORTED COMPLICATIONS OTHER THAN MILD DIFFUSE BLEEDING. AS REPORTED, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT WITH STABLE HEMODYNAMIC PARAMETERS. THE FOLLOW UP ECHO PERFORMED ON (B)(6) 2025 WAS SHOWING NORMAL CHAMBER SIZE, HYPERTROPHIC WALL, GOOD SYSTOLIC FUNCTION OF THE LEFT VENTRICLE, NORMAL-SIZED ATRIA, NORMAL-SIZED, GOOD LONGITUDINAL CONTRACTION OF THE RIGHT VENTRICLE, ANTERIOR HYPOKINESIS WAS NOTED; A WELL-FUNCTIONING MECHANICAL PROSTHETIC VALVE IN AORTIC POSITION, WITH NO PVL VISIBLE, MILD AOI AND MILD SECONDARY MI AND TI WERE REPORTED; NO SIGNIFICANT PERICARDIAL FLUID WAS VISIBLE.
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 HAS BEEN NOTIFIED OF A CASE OF RECURRENT AI INVOLVING A PATIENT TREATED WITH A HAART 200 DEVICE. REPORTEDLY, THE PATIENT UNDERWENT AORTIC VALVULOPLASTY DUE TO FUNCTIONAL BICUSPID AORTIC VALVE ON (B)(6) 2024 THROUGH PARTIAL STERNOTOMY. PRE-OPERATIVE ECHOCARDIOGRAPHIC EXAMINATION SHOWED A LEFT VENTRICLE WITH SLIGHTLY LARGER CAVITY SIZE, SEPTALLY HYPERTROPHIC WALL THICKNESS, GOOD SYSTOLIC FUNCTION, NORMAL ATRIA DIMENSIONS AND NORMAL RIGHT VENTRICLE DIMENSIONS WITH GOOD LONGITUDINAL CONTRACTION, SEVERE ORGANIC AORTIC INSUFFICIENCY, MILD SECONDARY MITRAL AND TRICUSPID REGURGITATION. BASED ON THE INFORMATION RECEIVED, AFTER PERFORMING THE SIZING PROCEDURE A SIZE 21 RING WAS SELECTED AND IMPLANTED IN SUB ANNULAR POSITION. THE REPAIR WAS COMPLETED BY PLICATING THE NON-CORONARY LEAFLET WITH 6/0 KNOTTED PROLENE SUTURES AND THE FUSED LEFT-RIGHT LEAFLET WITH 6 STITCHES, ACHIEVING A GOOD COAPTATION. THE EARLY POST-OPERATIVE TRANSTHORACIC ECHOCARDIOGRAPHY CONFIRMED THE SUCCESSFUL CORRECTION OF THE AORTIC INSUFFICIENCY, HOWEVER AN INCREASED GRADIENT WAS DETECTED (GRADE 1 STENOSIS). AT AN ECHOCARDIOGRAPHIC FOLLOW-UP PERFORMED ON (B)(6) 2025, RECURRENT PROLAPSE WITH PROGRESSIVE, SIGNIFICANT RECURRENT AI AND INCREASED GRADIENT VALUES WERE DETECTED. IN ADDITION, BILLOWING MITRAL ANTERIOR AND TRICUSPID LEAFLETS WERE NOTED, LEADING TO MITRAL AND MILD TRICUSPID INSUFFICIENCY. AS SUCH, THE INDICATION FOR REOPERATION WAS POSED AND RE-DO SURGERY WAS PERFORMED ON (B)(6) 2025. BASED ON THE INFORMATION RECEIVED, A PERFORATION ALONG THE ANNULAR PLANE AT THE FUSED AND PREVIOUSLY SUTURED RIGHT-LEFT CORONARY CUSP, WAS IDENTIFIED INTRA-OPERATIVELY RESULTING IN VALVULAR INSUFFICIENCY. THE RING, ALONG WITH THE ASSOCIATED TEFLON SUTURES¿WHICH HAD UNDERGONE ENDOTHELIALIZATION SINCE THE PRIOR INTERVENTION¿WAS EXPLANTED WITHOUT RESISTANCE AND THE SMALL HOLE COMMUNICATING WITH THE LEFT ATRIUM IN THE AORTIC OUTFLOW TRACT WAS CLOSED WITH 5/0 SUTURE. NO VEGETATIONS WERE OBSERVED ON THE EXPLANTED RING. REPORTEDLY, THE SURGERY WAS COMPLETED BY IMPLANTING A BICARBON SLIMLINE 25 MM (SN (B)(6) AORTIC MECHANICAL PROSTHESIS WITH NO REPORTED COMPLICATIONS OTHER THAN MILD DIFFUSE BLEEDING. AS REPORTED, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT WITH STABLE HEMODYNAMIC PARAMETERS. THE FOLLOW UP ECHO PERFORMED ON (B)(6) 2025 WAS SHOWING NORMAL CHAMBER SIZE, HYPERTROPHIC WALL, GOOD SYSTOLIC FUNCTION OF THE LEFT VENTRICLE, NORMAL-SIZED ATRIA, NORMAL-SIZED, GOOD LONGITUDINAL CONTRACTION OF THE RIGHT VENTRICLE, ANTERIOR HYPOKINESIS WAS NOTED; A WELL-FUNCTIONING MECHANICAL PROSTHETIC VALVE IN AORTIC POSITION, WITH NO PVL VISIBLE, MILD SECONDARY MI AND TI WERE REPORTED; NO SIGNIFICANT PERICARDIAL WAS FLUID VISIBLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1090289 | HAART 200 AORTIC ANNULOPLASTY RING | AORTIC ANNULOPLASTY RING | KRH | CORCYM INC. | HAART 200-21 | 01-01097 | 10857160006147 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Unknown | Required Intervention |