PHOTOFIX UNKNOWN CONFIGURATION
Report
- Report Number
- 1063481-2025-00031
- Event Type
- Death
- Date Received
- April 10, 2025
- Report Date
- June 16, 2025
- Manufacturer
- ARTIVION, INC. ¿ KENNESA
- Product Code
- QSK
- PMA / PMN Number
- K172085
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- 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 INITIAL REPORTS REGARDING THE RECENT PRE-PROOF OF THE ARTICLE TITLED: ¿MID-TERM RESULTS OF OZAKI TECHNIQUE FOR AORTIC VALVE RECONSTRUCTION COMPARING AUTOLOGOUS AND BOVINE PERICARDIUM IN CONGENITAL AORTIC VALVE DISEASE¿ BY CHAVEZ, M, ET AL., WAS RECENTLY RELEASED IN JTCVS STRUCTURAL AND ENDOVASCULAR; "IT REPORTS ON AORTIC VALVE RECONSTRUCTION COMPARING AUTOLOGOUS PERICARDIUM TO PHOTOFIX. IT IS A RETROSPECTIVE REVIEW OF PATIENTS WITH THREE-LEAFLET RECONSTRUCTION FROM 8/2015 TO 6/2023. THE SERIES REPORTS ON 74 PATIENTS (31 AUTOLOGOUS AND 43 PHOTOFIX). TWENTY-FIVE OF 43 (58%) OF PHOTOFIX PATIENTS REQUIRED AORTIC VALVE REOPERATION. FAILURE MODE FOR PHOTOFIX WAS REPORTED AS DEHISCENCE AT THE ANNULAR SUTURE LINE. AUTHORS CONCLUDE POOR MID-TERM RESULTS WITH PHOTOFIX BOVINE PERICARDIUM. AS NOTED IN OUR LABELING, THE USE OF PHOTOFIX FOR LEAFLET RECONSTRUCTION IS A CONTRAINDICATION." THIS INVESTIGATION IS RELEGATED TO PHOTOFIX UNKNOWN CONFIGURATION FOR THE FOLLOWING 5 EVENTS.DEATH,REGURGITATION,REOPERATION,DEHISCENCE,ENDOCARDITIS.MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION HAVE GONE UNMET. NO ADDITIONAL INFORMATION IS FORTHCOMING. 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. PER THE MANUSCRIPT, 2 PHOTOFIX PATIENTS RETURNED WITH VALVE ENDOCARDITIS AND THERE WERE 6 DEATHS (1 AUTOLOGOUS AND 5 PHOTOFIX RECIPIENTS) REPORTED AFTER DISCHARGE. THE CAUSE OF DEATH(S) LISTED IN THE REPORT ARE NOT SPECIFIC TO TISSUE RECIPIENT, NOR ARE THEY STATED TO BE DIRECTLY ATTRIBUTED TO EITHER PATCH USE. AORTIC REGURGITATION WAS NOTED IN BOTH TISSUE TYPES AND PATHOLOGIC EVALUATION WAS PERFORMED ON EXPLANTED TISSUE. FAILURE MODE FOR AUTOLOGOUS PERICARDIUM WAS RELATED TO EXTENSIVE FIBROUS GROWTH AND CALCIFICATION THROUGHOUT THE LEAFLETS, WITH THE PHOTOFIX SAMPLES SHOWING FIBROSIS WITH MYXOID DEGENERATION, PRESENTING WITH DEHISCENCE AT THE SUTURE LINE. THE PRIMARY ENDPOINT OF THE EVALUATION WAS SURGICAL RE-INTERVENTION. BOTH TISSUE TYPES HAD A 97% FREEDOM FROM RE-OPERATION AT 1-YEAR FOLLOW-UP, BUT THERE WAS A STATISTICALLY SIGNIFICANT DIFFERENCE AT FIVE YEARS FOLLOW-UP IN FAVOR OF AUTOLOGOUS PERICARDIUM (76% VS 30%, P=0.006). PATIENTS OF BOTH TISSUE TYPES UNDERWENT CONCOMITANT AORTIC VALVE/CARDIAC PROCEDURES DURING THEIR INCIDENT OPERATION; THE REPORT DOES NOT DELINEATE ANY POTENTIAL CORRELATION OF THE IMPACT OF THESE ON THE REPORTED OUTCOMES WITH EITHER TISSUE TYPE. ADHESION, DEATH, INFECTION, REJECTION AND INFLAMMATORY REACTIONS ARE LISTED AS KNOWN ADVERSE EVENTS FOR PERICARDIAL PATCHES AND ARE LISTED IN THE PHOTOFIX INSTRUCTIONS FOR USE (IFU). AS NOTED IN THE TITLE, THE PATIENT COHORT IN THIS EVALUATION ALL PRESENT WITH CONGENITAL AORTIC VALVE DISEASE; REOPERATION IS NOT AN UNEXPECTED EVENT FOR THIS PATIENT POPULATION. PHOTOFIX MANUFACTURING PROCESS INCLUDES 100% VISUAL INSPECTION PRIOR TO PACKAGING. THE REPORTED EVENTS ARE NOT UNEXPECTED OUTCOMES FOR THIS PATIENT POPULATION. THE RELATIONSHIP BETWEEN THE REPORTED EVENTS AND PHOTOFIX CANNOT BE DETERMINED WITHOUT ADDITIONAL INFORMATION. ADEQUATE PRECAUTIONS ARE LISTING IN OUR LABELING, THE PHOTOFIX IFU SPECIFIES THAT PHOTOFIX IS CONTRAINDICATED FOR VALVE LEAFLET REPAIR. THE PHOTOFIX DECELLULARIZED BOVINE PERICARDIUM A/DFMEA WAS REVIEWED. THE REPORTED EVENT IS ADDRESSED. THIS COMPLAINT REPORTS ADVERSE EVENTS (AE) IDENTIFIED IN LITERATURE AND DOES NOT SPECIFY POTENTIAL CAUSES OF FAILURE. DUE TO THE LIMITED INFORMATION AND UNKNOWN TIME TO EVENTS, IT CANNOT BE DETERMINED IF THE REPORTED EVENTS ARE DIRECTLY RELATED TO THE PHOTOFIX. AS SUCH, NO RISK OCCURRENCE ANALYSIS WAS PERFORMED IN THIS REPORT. THE REPORTED EVENTS WILL CONTINUE TO BE MONITORED FOR TRENDS. NO UPDATES TO THE RMF ARE NEEDED IN RESPONSE TO THIS COMPLAINT. RISK HAS BEEN REDUCED AS LOW AS POSSIBLE AND OVERALL RESIDUAL RISK IS ACCEPTABLE. A COMPLAINT AND RECALL QUERY COULD NOT BE PERFORMED AS THE LOT NUMBER 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 INITIAL REPORTS REGARDING THE RECENT PRE-PROOF OF THE ARTICLE TITLED: ¿MID-TERM RESULTS OF OZAKI TECHNIQUE FOR AORTIC VALVE RECONSTRUCTION COMPARING AUTOLOGOUS AND BOVINE PERICARDIUM IN CONGENITAL AORTIC VALVE DISEASE¿ BY CHAVEZ, M, ET AL., WAS RECENTLY RELEASED IN JTCVS STRUCTURAL AND ENDOVASCULAR; "IT REPORTS ON AORTIC VALVE RECONSTRUCTION COMPARING AUTOLOGOUS PERICARDIUM TO PHOTOFIX®. IT IS A RETROSPECTIVE REVIEW OF PATIENTS WITH THREE-LEAFLET RECONSTRUCTION FROM 8/2015 TO 6/2023. THE SERIES REPORTS ON 74 PATIENTS (31 AUTOLOGOUS AND 43 PHOTOFIX). TWENTY-FIVE OF 43 (58%) OF PHOTOFIX PATIENTS REQUIRED AORTIC VALVE REOPERATION. FAILURE MODE FOR PHOTOFIX WAS REPORTED AS DEHISCENCE AT THE ANNULAR SUTURE LINE. AUTHORS CONCLUDE POOR MID-TERM RESULTS WITH PHOTOFIX BOVINE PERICARDIUM. AS NOTED IN OUR LABELING, THE USE OF PHOTOFIX FOR LEAFLET RECONSTRUCTION IS A CONTRAINDICATION." THIS INVESTIGATION IS RELEGATED TO PHOTOFIX UNKNOWN CONFIGURATION FOR THE FOLLOWING 5 EVENTS. DEATH, REGURGITATION, REOPERATION, DEHISCENCE, ENDOCARDITIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 416820 | PHOTOFIX UNKNOWN CONFIGURATION | HYBRID STENT GRAFT, THORACIC AORTIC LESION TREATMENT | QSK | ARTIVION, INC. ¿ KENNESA | PF UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other| R| D| H| L |