CHORDX UNKNOWN CONFIGURATION
Report
- Report Number
- 1649833-2024-00072
- Event Type
- Injury
- Date Received
- December 17, 2024
- Report Date
- February 6, 2025
- Manufacturer
- ON-X LIFE TECHNOLOGIES, INC.
- Product Code
- PAW
- PMA / PMN Number
- K141060
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ACCORDING TO PRE-PUBLICATION ¿SIMPLIFYING MITRAL VALVE REPAIR WITH NOVEL PREMEASURED CHORDAL LOOPS¿, DANIEL SHELL, NATCHA BUNWATCHARAPHAN, MICHAEL SEITZ, MICHAEL ROWLAND, MANORAS CHENGALATH, AND CHENG-HON YAP, (ACCEPTED FOR PUBLICATION IN NOV 2024 BY THE JOURNAL OF CLINICAL MEDICINE); THIS WAS A RETROSPECTIVE COHORT STUDY CONDUCTED TO EVALUATE TO USE OF CHORD-X LOOPS IN 40 CONSECUTIVE PATIENTS WHO UNDERWENT SURGERY IN GEELONG, VICTORIA, AUSTRALIA BETWEEN MAY 2020 AND FEBRUARY 2024. THIS INVESTIGATION IS RELEGATED TO CHORD-X OF UNKNOWN CONFIGURATION FOR A TOTAL OF 7 EVENTS: 1 PATIENT REQUIRED A RETURN TO THEATRE FOR CONTROL OF BLEEDING AND THIS RESULTED IN A PROLONGED STAY. 1 RETURN TO THE ICU. 5 PATIENTS WERE READMITTED WITHIN 30-DAYS OF OPERATION, EITHER DUE TO ARRHYTHMIA OR NON-CARDIAC CONCERNS. MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION HAVE GONE UNMET. A REVIEW OF MANUFACTURING RECORDS COULD NOT BE PERFORMED AS A DEFINITIVE SERIAL NUMBER AND DATE OF SURGERY WERE NOT PROVIDED BY THE COMPLAINANT. A REVIEW OF THE AVAILABLE INFORMATION WAS PERFORMED. THE PUBLICATION ¿SIMPLIFYING MITRAL VALVE REPAIR WITH NOVEL PREMEASURED CHORDAL LOOPS¿ BY YAP ET ALL PUBLISHED IN 2024 IS REVIEWED HERE. DATA FROM A RETROSPECTIVE COHORT STUDY CONSISTS OF 40 CONSECUTIVE PATIENTS WHO UNDERWENT SURGERY FOR CHORDAL MITRAL REPAIR IN GEELONG, VICTORIA, AUSTRALIA BETWEEN MAY 2020 AND FEBRUARY 2024. THE STUDY AIM WAS TO EXPAND THE KNOWLEDGE BASE OF THIS INNOVATIVE MITRAL VALVE REPAIR TECHNOLOGY BY DOCUMENTING EXPERIENCE AND EARLY REPAIR OUTCOMES IN THE FIRST 40 PATIENTS. PATIENTS WERE SELECTED FOR THIS OPERATIVE TECHNIQUE BASED ON PRE-OPERATIVE ECHOCARDIOGRAPHY INDICATING THAT THEIR MITRAL VALVE PATHOLOGY WAS AMENABLE TO REPAIR. DATA WAS COLLECTED RETROSPECTIVELY FROM THE PATIENT¿S MEDICAL RECORDS, INCLUDING OPERATIVE NOTES, DISCHARGE PAPERWORK AND POST-OPERATIVE ECHOCARDIOGRAPHY REPORTS. DURATION AND FREQUENCY OF FOLLOW-UP ECHOCARDIOGRAPHY WAS DETERMINED BY THE PATIENT¿S TREATING CARDIOLOGIST, AND ONLY DATA FROM THE LATEST FOLLOW-UP WERE EVALUATED. THE UNDERLYING PATHOLOGY WAS MYXOMATOUS VALVE DEGENERATION IN ALL CASES, WITH NO IN-STANCES OF RHEUMATIC OR ISCHEMIC MITRAL DISEASE IN THIS DATASET. MEAN AGE OF THE PATIENTS AT OPERATION WAS 69 ± 12 YEARS WITH 63% OF PATIENTS BEING MALE. INTRAOPERATIVE ECHOCARDIOGRAPHY WAS UTILIZED FOR EVERY PROCEDURE AND CONFIRMED NO GREATER THAN MILD MR IN ALL PATIENTS AT THE CONCLUSION OF THE PROCEDURE, WITH 35 (88%) HAVING NONE OR TRIVIAL REGURGITATION AND 5 (12%) WITH MILD REGURGITATION. THERE WERE 7 COMPLICATIONS LISTED; 5 READMISSIONS WITHIN 30 DAYS DUE TO ARRHYTHMIA OR NON-CARDIAC CONCERNS, 1 RETURN TO THEATER FOR BLEEDING AND 1 RETURN TO THE ICU. IN ADDITION, ONE OF THE EARLIER PATIENTS REQUIRED A RETURN ONTO CPB AFTER WEANING OFF, AS THE CHORD-X PROSTHESIS HAD DISLODGED FROM THE PAPILLARY MUSCLE. THE LEAFLET ATTACHMENTS WERE ALL INTACT AND THUS ONLY THE PAPILLARY MUSCLE ATTACHMENT NEEDED TO BE RE-ANCHORED. IT WAS REATTACHED TO THE SAME PAPILLARY MUSCLE HEAD (BUT SLIGHTLY DEEPER) A SECOND TIME WITH NO FURTHER COMPLICATIONS, AND A DURABLE LONG-TERM REPAIR WAS ACHIEVED WITHOUT NEED FOR RE-OPERATION. NO READMISSION WAS RELATED TO HEART FAILURE OR VALVE DETERIORATION, AND THERE WERE NO EARLY MORTALITIES. THE LONGEST POST-PROCEDURE ECHOCARDIOGRAPHY FOLLOW-UP WAS 1288 DAYS. 75% OF PATIENTS HAD NIL OR TRACE MR, AND ONLY 25% HAD MILD MR AT TIME OF LATEST FOLLOW-UP. NO PATIENT TO DATE HAS HAD GREATER THAN MILD MR OR REQUIRED REINTERVENTION TO THEIR MITRAL VALVE. ACCORDING TO THE INVESTIGATORS THE MOST NOTABLE FINDING WAS THAT ALL SURGEONS WERE ABLE TO ACHIEVE SATISFACTORY MITRAL VALVE REPAIR IN ALL CASES, AS DEMONSTRATED BY EXCELLENT INTRAOPERATIVE ECHOCARDIOGRAPHY RESULTS, AND NO PATIENT REQUIRING CONVERSION TO MITRAL VALVE REPLACEMENT. IN FACT, THESE RESULTS WERE ACHIEVED BY SURGEONS WITH A RELATIVELY LOW ANNUAL VOLUME OF MITRAL VALVE REPAIRS. ALL INDICATED COMPLICATIONS ARE RECOGNIZED IN THE CHORD-X INSTRUCTIONS FOR USE [IFU]. ACCORDING TO THE AUTHORS THE RESULTS UNDERSCORE THE SAFETY AND REPRODUCIBILITY OF PRE-MEASURED LOOP SYSTEMS, PARTICULARLY THE CHORD-X PRE-MEASURED LOOPS SYSTEM. SURGEONS WITH RELATIVELY LOWER MITRAL CASE VOLUMES WERE ABLE TO IMPLEMENT THIS SYSTEM EFFECTIVELY IN A LOW-RISK COHORT WITH PRIMARILY POSTERIOR LEAFLET PROLAPSE. THIS PUBLICATION REVIEWED CLINICAL OUTCOMES FOR A SINGLE-CENTER EXPERIENCE FOR 40 PATIENTS WHO UNDERWENT MITRAL VALVE REPAIR WITH THE USE OF CHORD-X. ADVERSE EVENTS DETAILED IN THIS PUBLICATION (CARDIAC ARRYTHMIA, DEVICE DETACHMENT FROM THE PAPILLARY MUSCLE, AND REOPERATION) ARE RECOGNIZED IN THE DEVICE¿S INSTRUCTIONS FOR USE [IFU] AND NO NEW OR UNEXPECTED ADVERSE EVENTS WERE FOUND. SPECIFIC TO THE EVENT OF DEVISE DETACHMENT FROM THE PAPILLARY MUSCLE, THIS CAN BE CAUSED BY A FEW FACTORS INCLUDING PATIENT ANATOMY AND CONDITION OF THE LEAFLETS AND PAPILLARY MUSCLE AND/OR SURGEON TECHNIQUE. THE DATA COLLECTED IS PART OF A CLINICAL STUDY; THUS, SEVERITY AND OCCURRENCE IS NOT EVALUATED. THE REPORTED EVENTS WILL CONTINUE TO BE MONITORED FOR TRENDS. A COMPLAINT AND RECALL QUERY COULD NOT BE PERFORMED AS THE SERIAL NUMBER IS UNKNOWN. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE FOR THIS EVENT CANNOT BE DETERMINED. THIS PUBLICATION REVIEWED CLINICAL OUTCOMES FOR A SINGLE-CENTER EXPERIENCE FOR 40 PATIENTS WHO UNDERWENT MITRAL VALVE REPAIR WITH THE USE OF CHORD-X. ADVERSE EVENTS DETAILED IN THIS PUBLICATION (CARDIAC ARRYTHMIA, DEVICE DETACHMENT FROM THE PAPILLARY MUSCLE, AND REOPERATION) ARE RECOGNIZED IN THE DEVICE¿S INSTRUCTIONS FOR USE [IFU] AND NO NEW OR UNEXPECTED ADVERSE EVENTS WERE FOUND. SPECIFIC TO THE EVENT OF DEVISE DETACHMENT FROM THE PAPILLARY MUSCLE, THIS CAN BE CAUSED BY A FEW FACTORS INCLUDING PATIENT ANATOMY AND CONDITION OF THE LEAFLETS AND PAPILLARY MUSCLE AND/OR SURGEON TECHNIQUE. 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.
ADDITIONAL INFORMATION: 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 PRE-PUBLICATION ¿SIMPLIFYING MITRAL VALVE REPAIR WITH NOVEL PREMEASURED CHORDAL LOOPS¿, DANIEL SHELL, NATCHA BUNWATCHARAPHAN, MICHAEL SEITZ, MICHAEL ROWLAND, MANORAS CHENGALATH, AND CHENG-HON YAP, (ACCEPTED FOR PUBLICATION IN NOV 2024 BY THE JOURNAL OF CLINICAL MEDICINE); THIS WAS A RETROSPECTIVE COHORT STUDY CONDUCTED TO EVALUATE TO USE OF CHORD-X LOOPS IN 40 CONSECUTIVE PATIENTS WHO UNDERWENT SURGERY IN GEELONG, VICTORIA, AUSTRALIA BETWEEN MAY 2020 AND FEBRUARY 2024. THIS INVESTIGATION IS RELEGATED TO CHORD-X OF UNKNOWN CONFIGURATION FOR A TOTAL OF 7 EVENTS: 1 PATIENT REQUIRED A RETURN TO THEATRE FOR CONTROL OF BLEEDING AND THIS RESULTED IN A PROLONGED STAY. 1 RETURN TO THE ICU. 5 PATIENTS WERE READMITTED WITHIN 30-DAYS OF OPERATION, EITHER DUE TO ARRHYTHMIA OR NON-CARDIAC CONCERNS. MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION HAVE GONE UNMET. A REVIEW OF MANUFACTURING RECORDS COULD NOT BE PERFORMED AS A DEFINITIVE SERIAL NUMBER AND DATE OF SURGERY WERE NOT PROVIDED BY THE COMPLAINANT. A REVIEW OF THE AVAILABLE INFORMATION WAS PERFORMED. THE PUBLICATION ¿SIMPLIFYING MITRAL VALVE REPAIR WITH NOVEL PREMEASURED CHORDAL LOOPS¿ BY YAP ET ALL PUBLISHED IN 2024 IS REVIEWED HERE. DATA FROM A RETROSPECTIVE COHORT STUDY CONSISTS OF 40 CONSECUTIVE PATIENTS WHO UNDERWENT SURGERY FOR CHORDAL MITRAL REPAIR IN GEELONG, VICTORIA, AUSTRALIA BETWEEN MAY 2020 AND FEBRUARY 2024. THE STUDY AIM WAS TO EXPAND THE KNOWLEDGE BASE OF THIS INNOVATIVE MITRAL VALVE REPAIR TECHNOLOGY BY DOCUMENTING EXPERIENCE AND EARLY REPAIR OUTCOMES IN THE FIRST 40 PATIENTS. PATIENTS WERE SELECTED FOR THIS OPERATIVE TECHNIQUE BASED ON PRE-OPERATIVE ECHOCARDIOGRAPHY INDICATING THAT THEIR MITRAL VALVE PATHOLOGY WAS AMENABLE TO REPAIR. DATA WAS COLLECTED RETROSPECTIVELY FROM THE PATIENT¿S MEDICAL RECORDS, INCLUDING OPERATIVE NOTES, DISCHARGE PAPERWORK AND POST-OPERATIVE ECHOCARDIOGRAPHY REPORTS. DURATION AND FREQUENCY OF FOLLOW-UP ECHOCARDIOGRAPHY WAS DETERMINED BY THE PATIENT¿S TREATING CARDIOLOGIST, AND ONLY DATA FROM THE LATEST FOLLOW-UP WERE EVALUATED. THE UNDERLYING PATHOLOGY WAS MYXOMATOUS VALVE DEGENERATION IN ALL CASES, WITH NO IN-STANCES OF RHEUMATIC OR ISCHEMIC MITRAL DISEASE IN THIS DATASET. MEAN AGE OF THE PATIENTS AT OPERATION WAS 69 ± 12 YEARS WITH 63% OF PATIENTS BEING MALE. INTRAOPERATIVE ECHOCARDIOGRAPHY WAS UTILIZED FOR EVERY PROCEDURE AND CONFIRMED NO GREATER THAN MILD MR IN ALL PATIENTS AT THE CONCLUSION OF THE PROCEDURE, WITH 35 (88%) HAVING NONE OR TRIVIAL REGURGITATION AND 5 (12%) WITH MILD REGURGITATION. THERE WERE 7 COMPLICATIONS LISTED; 5 READMISSIONS WITHIN 30 DAYS DUE TO ARRHYTHMIA OR NON-CARDIAC CONCERNS, 1 RETURN TO THEATER FOR BLEEDING AND 1 RETURN TO THE ICU. IN ADDITION, ONE OF THE EARLIER PATIENTS REQUIRED A RETURN ONTO CPB AFTER WEANING OFF, AS THE CHORD-X PROSTHESIS HAD DISLODGED FROM THE PAPILLARY MUSCLE. THE LEAFLET ATTACHMENTS WERE ALL INTACT AND THUS ONLY THE PAPILLARY MUSCLE ATTACHMENT NEEDED TO BE RE-ANCHORED. IT WAS REATTACHED TO THE SAME PAPILLARY MUSCLE HEAD (BUT SLIGHTLY DEEPER) A SECOND TIME WITH NO FURTHER COMPLICATIONS, AND A DURABLE LONG-TERM REPAIR WAS ACHIEVED WITHOUT NEED FOR RE-OPERATION. NO READMISSION WAS RELATED TO HEART FAILURE OR VALVE DETERIORATION, AND THERE WERE NO EARLY MORTALITIES. THE LONGEST POST-PROCEDURE ECHOCARDIOGRAPHY FOLLOW-UP WAS 1288 DAYS. 75% OF PATIENTS HAD NIL OR TRACE MR, AND ONLY 25% HAD MILD MR AT TIME OF LATEST FOLLOW-UP. NO PATIENT TO DATE HAS HAD GREATER THAN MILD MR OR REQUIRED REINTERVENTION TO THEIR MITRAL VALVE. ACCORDING TO THE INVESTIGATORS THE MOST NOTABLE FINDING WAS THAT ALL SURGEONS WERE ABLE TO ACHIEVE SATISFACTORY MITRAL VALVE REPAIR IN ALL CASES, AS DEMONSTRATED BY EXCELLENT INTRAOPERATIVE ECHOCARDIOGRAPHY RESULTS, AND NO PATIENT REQUIRING CONVERSION TO MITRAL VALVE REPLACEMENT. IN FACT, THESE RESULTS WERE ACHIEVED BY SURGEONS WITH A RELATIVELY LOW ANNUAL VOLUME OF MITRAL VALVE REPAIRS. ALL INDICATED COMPLICATIONS ARE RECOGNIZED IN THE CHORD-X INSTRUCTIONS FOR USE [IFU]. ACCORDING TO THE AUTHORS THE RESULTS UNDERSCORE THE SAFETY AND REPRODUCIBILITY OF PRE-MEASURED LOOP SYSTEMS, PARTICULARLY THE CHORD-X PRE-MEASURED LOOPS SYSTEM. SURGEONS WITH RELATIVELY LOWER MITRAL CASE VOLUMES WERE ABLE TO IMPLEMENT THIS SYSTEM EFFECTIVELY IN A LOW-RISK COHORT WITH PRIMARILY POSTERIOR LEAFLET PROLAPSE. THIS PUBLICATION REVIEWED CLINICAL OUTCOMES FOR A SINGLE-CENTER EXPERIENCE FOR 40 PATIENTS WHO UNDERWENT MITRAL VALVE REPAIR WITH THE USE OF CHORD-X. ADVERSE EVENTS DETAILED IN THIS PUBLICATION (CARDIAC ARRYTHMIA, DEVICE DETACHMENT FROM THE PAPILLARY MUSCLE, AND REOPERATION) ARE RECOGNIZED IN THE DEVICE¿S INSTRUCTIONS FOR USE [IFU] AND NO NEW OR UNEXPECTED ADVERSE EVENTS WERE FOUND. SPECIFIC TO THE EVENT OF DEVISE DETACHMENT FROM THE PAPILLARY MUSCLE, THIS CAN BE CAUSED BY A FEW FACTORS INCLUDING PATIENT ANATOMY AND CONDITION OF THE LEAFLETS AND PAPILLARY MUSCLE AND/OR SURGEON TECHNIQUE. THE DATA COLLECTED IS PART OF A CLINICAL STUDY; THUS, SEVERITY AND OCCURRENCE IS NOT EVALUATED. THE REPORTED EVENTS WILL CONTINUE TO BE MONITORED FOR TRENDS. A COMPLAINT AND RECALL QUERY COULD NOT BE PERFORMED AS THE SERIAL NUMBER IS UNKNOWN. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE FOR THIS EVENT CANNOT BE DETERMINED. THIS PUBLICATION REVIEWED CLINICAL OUTCOMES FOR A SINGLE-CENTER EXPERIENCE FOR 40 PATIENTS WHO UNDERWENT MITRAL VALVE REPAIR WITH THE USE OF CHORD-X. ADVERSE EVENTS DETAILED IN THIS PUBLICATION (CARDIAC ARRYTHMIA, DEVICE DETACHMENT FROM THE PAPILLARY MUSCLE, AND REOPERATION) ARE RECOGNIZED IN THE DEVICE¿S INSTRUCTIONS FOR USE [IFU] AND NO NEW OR UNEXPECTED ADVERSE EVENTS WERE FOUND. SPECIFIC TO THE EVENT OF DEVISE DETACHMENT FROM THE PAPILLARY MUSCLE, THIS CAN BE CAUSED BY A FEW FACTORS INCLUDING PATIENT ANATOMY AND CONDITION OF THE LEAFLETS AND PAPILLARY MUSCLE AND/OR SURGEON TECHNIQUE. 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 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 PRE-PUBLICATION ¿SIMPLIFYING MITRAL VALVE REPAIR WITH NOVEL PREMEASURED CHORDAL LOOPS¿ DANIEL SHELL, NATCHA BUNWATCHARAPHAN, MICHAEL SEITZ, MICHAEL ROWLAND, MANORAS CHENGALATH, AND CHENG-HON YAP, (ACCEPTED FOR PUBLICATION IN NOV 2024 BY THE JOURNAL OF CLINICAL MEDICINE); THIS WAS A RETROSPECTIVE COHORT STUDY CONDUCTED TO EVALUATE TO USE OF CHORD-X LOOPS IN 40 CONSECUTIVE PATIENTS WHO UNDERWENT SURGERY IN GEELONG, VICTORIA, AUSTRALIA BETWEEN MAY 2020 THROUGH FEBRUARY 2024. THIS INVESTIGATION IS RELEGATED TO CHORD-X OF UNKNOWN CONFIGURATION. 1 PATIENT REQUIRED A RETURN TO THEATRE FOR CONTROL OF BLEEDING AND THIS RESULTED IN A PROLONGED STAY. 5 PATIENTS WERE READMITTED WITHIN 30-DAYS OF OPERATION, EITHER DUE TO ARRHYTHMIA OR NON-CARDIAC CONCERNS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1720079 | CHORDX UNKNOWN CONFIGURATION | NONABSORBABLE PTFE SUTURE FOR CHORDAE TENDINAE REPAIR | PAW | ON-X LIFE TECHNOLOGIES, INC. | CXL UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| O| L |