CHORDX UNKNOWN
Report
- Report Number
- 1649833-2025-00012
- Event Type
- Death
- Date Received
- May 6, 2025
- Report Date
- July 2, 2025
- Manufacturer
- ON-X LIFE TECHNOLOGIES, INC.
- Product Code
- PAW
- PMA / PMN Number
- K174060
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO ARTIVION ¿ FORMERLY CRYOLIFE/JOTEC IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION ¿ FORMERLY CRYOLIFE/JOTEC.
ACCORDING TO PUBLICATION "MINIMALLY INVASIVE MITRAL VALVE REPAIR WITH ARTIFICIAL CHORDAE. INSIGHTS FROM A 6 YEAR SINGLE CENTER STUDY¿, THIS PUBLICATION REPORTS ON A RETROSPECTIVE COHORT STUDY THAT WAS CONDUCTED ON CONSECUTIVE PATIENTS WHO UNDERWENT MIMVR USING ARTIFICIAL CHORDAE AT A SINGLE CENTER IN VIETNAM BETWEEN 2016 AND 2022. 90 PATIENTS WERE TREATED, 41 SIMPLE AND 49 INTERMEDIATE TO COMPLEX REPAIRS. NO CASES REQUIRED MR REPLACEMENT AND ALL OUTCOMES WERE FAVORABLE. THE MEDIAN FOLLOW UP TIME WAS 30.3 MONTHS AND THERE WERE TWO CARDIAC DEATHS, ONE IN EACH GROUP. THE KAPLAN¿MEIER SURVIVAL ESTIMATES FOR GROUPS 1 AND 2 AT 12 AND 24 MONTHS WERE 97% VS. 100% AND 97% VS. 96%, RESPECTIVELY, AND ESTIMATES FOR FREEDOM FROM RECURRENT MR WERE 97% VS. 92% AND 97% VS. 88%, RESPECTIVELY. THERE WAS A NEGATIVE ASSOCIATION BETWEEN THE VOLUME OF OPERATIONS AND THE DURATION OF OPERATION AND AORTIC CROSS CLAMP TIME, LEADING TO SHORTER DURATIONS. CONCLUSION. BASED ON OUR SINGLE-CENTER EXPERIENCE, MIMVR USING ARTI5CIAL CHORDAE VIA RIGHT MINI-THORACOTOMY CAN BE SAFELY AND EFFECTIVELY PERFORMED IN RESOURCE-LIMITED COUNTRIES FOR PATIENTS WITH MR. THIS APPROACH HAS BEEN SHOWN TO BE APPLICABLE FOR A RANGE OF MR COMPLEXITIES, FROM SIMPLE TO INTERMEDIATE-TO-COMPLEX MV REPAIRS AND HAS DEMONSTRATED PROMISING RESULTS IN TERMS OF MIDTERM FREEDOM FROM MR RECURRENCE. THIS INVESTIGATION IS RELEGATED TO CHORD-X UNKNOWN CONFIGURATION FOR THE FOLLOWING: DEATH (2). MITRAL VALVE REGURGITATION (33). MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION HAVE GONE UNMET. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. A REVIEW OF MANUFACTURING RECORDS COULD NOT BE PERFORMED AS A DEFINITIVE LOT/SERIAL NUMBER AND DATE OF SURGERY WERE NOT PROVIDED BY THE COMPLAINANT. A REVIEW OF THE AVAILABLE INFORMATION WAS PERFORMED. THIS INVESTIGATION REVIEWS CLINICAL OUTCOMES REPORTED IN THE 2023 PUBLICATION TITLED "MINIMALLY INVASIVE MITRAL VALVE REPAIR WITH ARTIFICIAL CHORDAE: INSIGHTS FROM A 6-YEAR SINGLE-CENTER STUDY" BY BUI ET AL. THE STUDY REPORTS A RETROSPECTIVE COHORT ANALYSIS OF 90 PATIENTS UNDERGOING MINIMALLY INVASIVE MITRAL VALVE REPAIR (MIMVR) AT A SINGLE CENTER IN VIETNAM BETWEEN APRIL 2016 AND APRIL 2022. ALL PROCEDURES UTILIZED ARTIFICIAL CHORDAE (CHORD-X LOOPS OR GORE CV-5 SUTURES) THROUGH A RIGHT MINITHORACOTOMY APPROACH. PATIENTS WERE DIVIDED INTO TWO GROUPS BASED ON THE ANYANWU COMPLEXITY SCORE: GROUP 1 INCLUDED SIMPLE REPAIRS (N=41), AND GROUP 2 INCLUDED INTERMEDIATE-TO-COMPLEX REPAIRS (N=49). THE MEAN AGE OF THE COHORT WAS 50.5 ± 12.9 YEARS, AND 77.8% WERE MALE. ALL CASES INVOLVED CARPENTIER TYPE II MITRAL REGURGITATION, PRIMARILY DUE TO FIBROELASTIC DEFICIENCY. BOTH CHORD-X AND GORE CV-5 SUTURES WERE USED FOR NEOCHORDAE IMPLANTATION. CHORD-X WAS USED IN 56% OF CASES, SINGLE GORE CV-5 IN 33%, AND BOTH TECHNIQUES COMBINED IN 11%. ALL PATIENTS ALSO UNDERWENT RING ANNULOPLASTY USING THE CARPENTIER PHYSIO II RING. THE STUDY REPORTS NO CONVERSIONS TO MITRAL VALVE REPLACEMENT AND NO REOPERATIONS RELATED TO THE MITRAL VALVE WERE OBSERVED DURING THE FOLLOW UP PERIOD. POSTOPERATIVE OUTCOMES INCLUDED TWO CARDIAC DEATHS (2.2%) DURING THE MEDIAN 30.3-MONTH FOLLOW-UP PERIOD, WITH ONE PATIENT READMITTED AFTER FOUR MONTHS DUE TO ACUTE HEART FAILURE AND THE OTHER PRESENTING WITH INFECTIVE ENDOCARDITIS TWO MONTHS POST-IMPLANT. ONE PATIENT (1.1%) EXPERIENCED A STROKE WITH SEQUELAE. REOPERATION FOR BLEEDING WAS REQUIRED IN THREE CASES (3.3%). MODERATE OR SEVERE RECURRENT MITRAL REGURGITATION OCCURRED IN 11.1% OF PATIENTS OVERALL, WITH A HIGHER INCIDENCE IN GROUP 2 (18.4%) COMPARED TO GROUP 1 (2.4%). SURVIVAL ESTIMATES AT 48 MONTHS WERE 97% FOR GROUP 1 AND 96% FOR GROUP 2 (P=0.850). KAPLAN-MEIER ESTIMATES FOR FREEDOM FROM RECURRENT MR AT 48 MONTHS WERE 97% FOR GROUP 1 AND 88% FOR GROUP 2 (P=0.260). THE AUTHORS CONCLUDED THAT MIMVR USING ARTIFICIAL CHORDAE (INCLUDING BOTH GORE CV-5 SUTURES AND CHORD-X LOOPS) IS SAFE AND EFFECTIVE ACROSS A RANGE OF MITRAL REGURGITATION COMPLEXITIES, EVEN IN RESOURCE-LIMITED SETTINGS. THIS CLINICAL OUTCOME ANALYSIS IS BASED ON A SINGLE-SURGEON EXPERIENCE USING ARTIFICIAL CHORDAE (GORE CV-5 AND CHORD-X) FOR MINIMALLY INVASIVE MITRAL VALVE REPAIR. THE STUDY DEMONSTRATED FAVORABLE MIDTERM SURVIVAL, LOW RATES OF REOPERATION, AND ACCEPTABLE RECURRENCE RATES OF MITRAL REGURGITATION. WHILE BOTH GORE CV-5 SUTURES AND CHORD-X LOOPS WERE EMPLOYED, THE PUBLICATION DOES NOT DISAGGREGATE OUTCOMES BY DEVICE TYPE. THEREFORE, IT IS NOT POSSIBLE TO ASSOCIATE SPECIFIC COMPLICATIONS OR EVENTS WITH EITHER PRODUCT INDIVIDUALLY. ALL REPORTED COMPLICATIONS, INCLUDING RECURRENT MR, PERIOPERATIVE STROKE, BLEEDING, AND MORTALITY, ARE CONSISTENT WITH THE KNOWN RISKS FOR MITRAL VALVE REPAIR PROCEDURES USING ARTIFICIAL CHORDAE AND ARE IDENTIFIED IN THE IFU. A COMPLAINT AND RECALL QUERY COULD NOT BE PERFORMED AS PRODUCT IDENTIFYING INFORMATION IS UNKNOWN. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE FOR THIS EVENT CANNOT BE DETERMINED. THIS EVENT DOES NOT IDENTIFY ADDITIONAL HAZARDS OR MODIFY THE PROBABILITY AND SEVERITY OF EXISTING HAZARDS. THERE IS NO INDICATION THAT AN ERROR OR DEFICIENCY OCCURRED AT ARTIVION ¿ FORMERLY CRYOLIFE/JOTEC AND THE IFU ADEQUATELY COMMUNICATES RISK. THIS COMPLAINT WAS REVIEWED FOR A CAPA EVALUATION AND A CAPA IS NOT WARRANTED AT THIS TIME. ARTIVION WILL CONTINUE TO MONITOR SIMILAR COMPLAINTS TO DETERMINE IF ADDITIONAL ACTIONS ARE WARRANTED; HOWEVER, AT THIS TIME NO FURTHER ACTIONS ARE NECESSARY. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO ARTIVION ¿ FORMERLY CRYOLIFE/JOTEC IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION ¿ FORMERLY CRYOLIFE/JOTEC.
ACCORDING TO PUBLICATION "MINIMALLY INVASIVE MITRAL VALVE REPAIR WITH ARTIFICIAL CHORDAE. INSIGHTS FROM A 6 YEAR SINGLE CENTER STUDY¿, THIS PUBLICATION REPORTS ON A RETROSPECTIVE COHORT STUDY THAT WAS CONDUCTED ON CONSECUTIVE PATIENTS WHO UNDERWENT MIMVR USING ARTIFICIAL CHORDAE AT A SINGLE CENTER IN VIETNAM BETWEEN 2016 AND 2022. 90 PATIENTS WERE TREATED, 41 SIMPLE AND 49 INTERMEDIATE TO COMPLEX REPAIRS. NO CASES REQUIRED MR REPLACEMENT AND ALL OUTCOMES WERE FAVORABLE. THE MEDIAN FOLLOW UP TIME WAS 30.3 MONTHS AND THERE WERE TWO CARDIAC DEATHS, ONE IN EACH GROUP. THE KAPLAN¿MEIER SURVIVAL ESTIMATES FOR GROUPS 1 AND 2 AT 12 AND 24 MONTHS WERE 97% VS. 100% AND 97% VS. 96%, RESPECTIVELY, AND ESTIMATES FOR FREEDOM FROM RECURRENT MR WERE 97% VS. 92% AND 97% VS. 88%, RESPECTIVELY. THERE WAS A NEGATIVE ASSOCIATION BETWEEN THE VOLUME OF OPERATIONS AND THE DURATION OF OPERATION AND AORTIC CROSS CLAMP TIME, LEADING TO SHORTER DURATIONS. CONCLUSION. BASED ON OUR SINGLE-CENTER EXPERIENCE, MIMVR USING ARTI5CIAL CHORDAE VIA RIGHT MINI-THORACOTOMY CAN BE SAFELY AND E2ECTIVELY PERFORMED IN RESOURCE-LIMITED COUNTRIES FOR PATIENTS WITH MR. THIS APPROACH HAS BEEN SHOWN TO BE APPLICABLE FOR A RANGE OF MR COMPLEXITIES, FROM SIMPLE TO INTERMEDIATE-TO-COMPLEX MV REPAIRS, AND HAS DEMONSTRATED PROMISING RESULTS IN TERMS OF MIDTERM FREEDOM FROM MR RECURRENCE. THIS INVESTIGATION IS RELEGATED TO CHORD-X UNKNOWN CONFIGURATION FOR THE FOLLOWING: DEATH (2). MITRAL VALVE REGURGITATION (33). MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION HAVE GONE UNMET. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. A REVIEW OF MANUFACTURING RECORDS COULD NOT BE PERFORMED AS A DEFINITIVE LOT/SERIAL NUMBER AND DATE OF SURGERY WERE NOT PROVIDED BY THE COMPLAINANT. A REVIEW OF THE AVAILABLE INFORMATION WAS PERFORMED. THIS INVESTIGATION REVIEWS CLINICAL OUTCOMES REPORTED IN THE 2023 PUBLICATION TITLED "MINIMALLY INVASIVE MITRAL VALVE REPAIR WITH ARTIFICIAL CHORDAE: INSIGHTS FROM A 6-YEAR SINGLE-CENTER STUDY" BY BUI ET AL. THE STUDY REPORTS A RETROSPECTIVE COHORT ANALYSIS OF 90 PATIENTS UNDERGOING MINIMALLY INVASIVE MITRAL VALVE REPAIR (MIMVR) AT A SINGLE CENTER IN VIETNAM BETWEEN APRIL 2016 AND APRIL 2022. ALL PROCEDURES UTILIZED ARTIFICIAL CHORDAE (CHORD-X LOOPS OR GORE CV-5 SUTURES) THROUGH A RIGHT MINITHORACOTOMY APPROACH. PATIENTS WERE DIVIDED INTO TWO GROUPS BASED ON THE ANYANWU COMPLEXITY SCORE: GROUP 1 INCLUDED SIMPLE REPAIRS (N=41), AND GROUP 2 INCLUDED INTERMEDIATE-TO-COMPLEX REPAIRS (N=49). THE MEAN AGE OF THE COHORT WAS 50.5 ± 12.9 YEARS, AND 77.8% WERE MALE. ALL CASES INVOLVED CARPENTIER TYPE II MITRAL REGURGITATION, PRIMARILY DUE TO FIBROELASTIC DEFICIENCY. BOTH CHORD-X AND GORE CV-5 SUTURES WERE USED FOR NEOCHORDAE IMPLANTATION. CHORD-X WAS USED IN 56% OF CASES, SINGLE GORE CV-5 IN 33%, AND BOTH TECHNIQUES COMBINED IN 11%. ALL PATIENTS ALSO UNDERWENT RING ANNULOPLASTY USING THE CARPENTIER PHYSIO II RING. THE STUDY REPORTS NO CONVERSIONS TO MITRAL VALVE REPLACEMENT AND NO REOPERATIONS RELATED TO THE MITRAL VALVE WERE OBSERVED DURING THE FOLLOW UP PERIOD. POSTOPERATIVE OUTCOMES INCLUDED TWO CARDIAC DEATHS (2.2%) DURING THE MEDIAN 30.3-MONTH FOLLOW-UP PERIOD, WITH ONE PATIENT READMITTED AFTER FOUR MONTHS DUE TO ACUTE HEART FAILURE AND THE OTHER PRESENTING WITH INFECTIVE ENDOCARDITIS TWO MONTHS POST-IMPLANT. ONE PATIENT (1.1%) EXPERIENCED A STROKE WITH SEQUELAE. REOPERATION FOR BLEEDING WAS REQUIRED IN THREE CASES (3.3%). MODERATE OR SEVERE RECURRENT MITRAL REGURGITATION OCCURRED IN 11.1% OF PATIENTS OVERALL, WITH A HIGHER INCIDENCE IN GROUP 2 (18.4%) COMPARED TO GROUP 1 (2.4%). SURVIVAL ESTIMATES AT 48 MONTHS WERE 97% FOR GROUP 1 AND 96% FOR GROUP 2 (P=0.850). KAPLAN-MEIER ESTIMATES FOR FREEDOM FROM RECURRENT MR AT 48 MONTHS WERE 97% FOR GROUP 1 AND 88% FOR GROUP 2 (P=0.260). THE AUTHORS CONCLUDED THAT MIMVR USING ARTIFICIAL CHORDAE (INCLUDING BOTH GORE CV-5 SUTURES AND CHORD-X LOOPS) IS SAFE AND EFFECTIVE ACROSS A RANGE OF MITRAL REGURGITATION COMPLEXITIES, EVEN IN RESOURCE-LIMITED SETTINGS. THIS CLINICAL OUTCOME ANALYSIS IS BASED ON A SINGLE-SURGEON EXPERIENCE USING ARTIFICIAL CHORDAE (GORE CV-5 AND CHORD-X) FOR MINIMALLY INVASIVE MITRAL VALVE REPAIR. THE STUDY DEMONSTRATED FAVORABLE MIDTERM SURVIVAL, LOW RATES OF REOPERATION, AND ACCEPTABLE RECURRENCE RATES OF MITRAL REGURGITATION. WHILE BOTH GORE CV-5 SUTURES AND CHORD-X LOOPS WERE EMPLOYED, THE PUBLICATION DOES NOT DISAGGREGATE OUTCOMES BY DEVICE TYPE. THEREFORE, IT IS NOT POSSIBLE TO ASSOCIATE SPECIFIC COMPLICATIONS OR EVENTS WITH EITHER PRODUCT INDIVIDUALLY. ALL REPORTED COMPLICATIONS, INCLUDING RECURRENT MR, PERIOPERATIVE STROKE, BLEEDING, AND MORTALITY, ARE CONSISTENT WITH THE KNOWN RISKS FOR MITRAL VALVE REPAIR PROCEDURES USING ARTIFICIAL CHORDAE AND ARE IDENTIFIED IN THE IFU. A COMPLAINT AND RECALL QUERY COULD NOT BE PERFORMED AS PRODUCT IDENTIFYING INFORMATION IS UNKNOWN. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE FOR THIS EVENT CANNOT BE DETERMINED. THIS EVENT DOES NOT IDENTIFY ADDITIONAL HAZARDS OR MODIFY THE PROBABILITY AND SEVERITY OF EXISTING HAZARDS. THERE IS NO INDICATION THAT AN ERROR OR DEFICIENCY OCCURRED AT ARTIVION ¿ FORMERLY CRYOLIFE/JOTEC AND THE IFU ADEQUATELY COMMUNICATES RISK. THIS COMPLAINT WAS REVIEWED FOR A CAPA EVALUATION AND A CAPA IS NOT WARRANTED AT THIS TIME. ARTIVION WILL CONTINUE TO MONITOR SIMILAR COMPLAINTS TO DETERMINE IF ADDITIONAL ACTIONS ARE WARRANTED; HOWEVER, AT THIS TIME NO FURTHER ACTIONS ARE NECESSARY. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO ARTIVION ¿ FORMERLY CRYOLIFE/JOTEC IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION ¿ FORMERLY CRYOLIFE/JOTEC.
ACCORDING TO PUBLICATION "MINIMALLY INVASIVE MITRAL VALVE REPAIR WITH ARTIFICIAL CHORDAE. INSIGHTS FROM A 6 YEAR SINGLE CENTER STUDY¿, THIS PUBLICATION REPORTS ON A RETROSPECTIVE COHORT STUDY THAT WAS CONDUCTED ON CONSECUTIVE PATIENTS WHO UNDERWENT MIMVR USING ARTIFICIAL CHORDAE AT A SINGLE CENTER IN VIETNAM BETWEEN 2016 AND 2022. 90 PATIENTS WERE TREATED, 41 SIMPLE AND 49 INTERMEDIATE TO COMPLEX REPAIRS. NO CASES REQUIRED MR REPLACEMENT AND ALL OUTCOMES WERE FAVORABLE. THE MEDIAN FOLLOW UP TIME WAS 30.3 MONTHS AND THERE WERE TWO CARDIAC DEATHS, ONE IN EACH GROUP. THE KAPLAN¿MEIER SURVIVAL ESTIMATES FOR GROUPS 1 AND 2 AT 12 AND 24 MONTHS WERE 97% VS. 100% AND 97% VS. 96%, RESPECTIVELY, AND ESTIMATES FOR FREEDOM FROM RECURRENT MR WERE 97% VS. 92% AND 97% VS. 88%, RESPECTIVELY. THERE WAS A NEGATIVE ASSOCIATION BETWEEN THE VOLUME OF OPERATIONS AND THE DURATION OF OPERATION AND AORTIC CROSS CLAMP TIME, LEADING TO SHORTER DURATIONS. CONCLUSION. BASED ON OUR SINGLE-CENTER EXPERIENCE, MIMVR USING ARTIFICIAL CHORDAE VIA RIGHT MINI-THORACOTOMY CA. BE SAFELY AND ELECTIVELY PERFORMED IN RESOURCE-LIMITED COUNTRIES FOR PATIENTS WITH MR. THIS APPROACH HAS BEEN SHOWN TO BE APPLICABLE FOR A RANGE OF MR COMPLEXITIES, FROM SIMPLE TO INTERMEDIATE-TO-COMPLEX MV REPAIRS, AND HAS DEMONSTRATED PROMISING RESULTS IN TERMS OF MIDTERM FREEDOM FROM MR RECURRENCE. THIS INVESTIGATION IS RELEGATED TO CHORD-X UNKNOWN CONFIGURATION FOR DEATH AND MITRAL VALVE REGURGITATION.. NO PRODUCT IDENTIFYING INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2102738 | CHORDX UNKNOWN | NONABSORBABLE PTFE SUTURE FOR CHORDAE TENDINAE REPAIR | PAW | ON-X LIFE TECHNOLOGIES, INC. | CXL UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death| R |