PHOTOFIX PATCH - 6CM X 8CM
Report
- Report Number
- 1063481-2023-00002
- Event Type
- Injury
- Date Received
- February 10, 2023
- Date of Event
- June 4, 2019
- Report Date
- March 29, 2023
- Manufacturer
- ARTIVION, INC. - KENNESAW
- Product Code
- PSQ
- PMA / PMN Number
- K183635
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
A PATIENT IN THE STUDY WAS HOSPITALIZED ON (B)(6) 2019 FOR A PLANNED SURGICAL PROCEDURE WHICH INCLUDED THE EXPLANT OF THE PREVIOUSLY IMPLANTED PHOTOFIX PATCH. PER THE OPERATIVE NOTE WHILE REMOVING THE OLD PHOTOFIX PERICARDIUM INFLAMMATORY TISSUE WAS OBSERVED. THE INFLAMED TISSUE WAS REMOVED DURING THIS PROCEDURE. ADDITIONAL INFORMATION FROM THE OPERATIVE NOTE RELAYS "THE ATRIAL FENESTRATION ON THE PHOTOFIX PATCH WAS GONE. IT WAS COVERED IN TISSUE. WE INCISED INTO THE ASD PATCH AND THERE WAS PURULENT MATERIAL THAT CAME OUT. SAMPLES WERE TAKEN FOR MICROBIOLOGY. WE ASPIRATED SOME FURTHER SAMPLES FOR STAT GRAM STAIN. STAT GRAM STRAIN [STAIN] REVELED INFLAMMATORY CELLS BUT NO ORGANISMS. THERE WAS A THICK RIND AROUND ALL THE PHOTOFIX. WE EXCISED IT AS MUCH AS POSSIBLE LEAVING SOME THAT WAS ATTACHED TO THE AV VALVE. MY SUSPICION IS THAT IS JUST AN INFLAMMATORY REACTION TO THE PHOTOFIX. THE PATIENT WAS WEANED FROM CARDIOPULMONARY BYPASS UNEVENTFULLY AND IN SINUS RHYTHM. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT IN STABLE CONDITION." PAST MEDICAL HISTORY: TRISOMY 21, TRACHEOMALACIA. FEEDING DIFFICULTY AND POOR WEIGHT GAIN S/P GT. CONGENITAL HYPOTHYROIDISM. PLAGIOCEPHALY. PATIENT STATUS UPDATE: THE PATIENT CONTINUED TO BE FOLLOWED AT BCH. HAD SUBSEQUENT CATHETERIZATIONS AND SURGERY FOR A BI-VENTRICULAR CONVERSION IN 2020. THE LATEST DATE PATIENT CAME IN FOR CARDIOLOGY FOLLOW-UP IS (B)(6) 2022, AND THE LATEST DATE CONTACTED BCH HOSPITAL (ANOTHER DEPARTMENT) IS 11/28/22. NO ADDITIONAL INFORMATION FORTHCOMING. THIS INVESTIGATION IS RELEGATED TO PFP 6X8 LOT#: 171191. THE MANUFACTURING RECORDS FOR PFP 6X8, LOT # 171191 WERE REVIEWED. AS THIS LOT WAS PRODUCED IN ITS ENTIRETY BY GENESEE BIOMEDICAL INC., ALL INSPECTIONS WERE PERFORMED AND DOCUMENTED BY GBI AND MET THEIR REQUIREMENTS FOR RELEASE. NO NCS HAVE BEEN INITIATED BY ARTIVION FOR THIS LOT. NO NCS/DEVIATIONS WERE RECORDED BY GBI PER THE DOCUMENTATION PROVIDED TO ARTIVION. THE EXPLANTED PHOTOFIX PATCH WAS NOT RETURNED FOR EVALUATION AND NO HISTOLOGY REPORT OF THE EXPLANTED MATERIAL HAS BEEN PROVIDED BY THE SITE. THE USE OF BOVINE PERICARDIAL PATCHES FOR CONGENITAL CARDIAC RECONSTRUCTIONS IS WELL ESTABLISHED. BAIRD ET AL. REPORT ON THE USE OF PHOTOFIX IN 383 OPERATIONS INCLUDING BOTH RIGHT AND LEFT SIDED CONGENITAL CARDIAC RECONSTRUCTIONS WHICH INCLUDED 8 EXPLANTED PATCH SPECIMENS THAT UNDERWENT HISTOLOGICAL EVALUATION. EIGHT PATCH SPECIMENS WERE AVAILABLE FOR HISTOLOGICAL ANALYSIS WITH THE EXPLANTS OCCURRING OVER VARIOUS TIME FRAMES SPANNING 1-72 MONTHS (MEAN 20 MONTHS) AFTER IMPLANTATION. HISTOPATHOLOGY SHOWS INFLAMMATION WAS ABSENT OR MINIMAL IN 6 CASES AND MILD IN 2 OTHERS. INFLAMMATION SEEMED RELATED TO USE IN AN AREA OF HIGH PRESSURE AND FLEXION (VENTRICULAR SEPTUM AND LEFT VENTRICLE) AND POSSIBLY DURATION IN SITU. IT IS UNCLEAR WHY THE PATIENT EXPERIENCED THIS INFLAMMATORY RESPONSE TO THE PHOTOFIX PATCH DESCRIBED ABOVE, HOWEVER; SIMILAR OUTCOMES HAVE BEEN REPORTED IN THE LITERATURE. ADDITIONALLY, POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF PERICARDIUM INCLUDES ABSCESS, ADHESION, EPICARDIAL INFLAMMATORY REACTIONS, AND REJECTION ARE INCLUDED IN THE INSTRUCTIONS FOR USE (IFU). THE CAUSE OF THE DESCRIBED EVENTS IS UNKNOWN ALTHOUGH THE SURGEON SUSPECTS THE EVENT TO BE AN INFLAMMATORY REACTION. INFLAMMATORY REACTION AND EXPLANT HAVE BEEN DESCRIBED IN THE LITERATURE. ADEQUATE PRECAUTIONS ARE PROVIDED IN THE IFU. THE PHOTOFIX DECELLULARIZED BOVINE PERICARDIUM FILE WAS REVIEWED. THE REPORTED EVENT IS ADDRESSED IN HAZARD STEP/ITEM # A.1 1A. THE LOT NUMBER FOR THE ASSOCIATED PATCH WAS PROVIDED, AND THE DEVICE MET ALL CRITERIA FOR FINAL DEVICE. NO SAMPLES WERE RETURNED FOR EVALUATION. THE CAUSE OF THE DESCRIBED EVENTS IS UNKNOWN ALTHOUGH THE SURGEON SUSPECTS THE EVENT TO BE AN INFLAMMATORY REACTION. INFLAMMATORY REACTION AND EXPLANT HAVE BEEN DESCRIBED IN THE LITERATURE. ADEQUATE PRECAUTIONS ARE PROVIDED IN THE IFU. THE REPORTED EVENT 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 RISK IS ACCEPTABLE. THIS COMPLAINT WAS REVIEWED FOR A CAPA EVALUATION. THE PROBABLE ROOT CAUSE OF THIS EVENT IS UNKNOWN. THE MANUFACTURING RECORDS WERE REVIEWED, AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS PER THE DEVICE MASTER RECORD. THE CAUSE OF THE DESCRIBED EVENTS IS UNKNOWN ALTHOUGH THE SURGEON SUSPECTS THE EVENT TO BE AN INFLAMMATORY REACTION. INFLAMMATORY REACTION AND EXPLANT HAVE BEEN DESCRIBED IN THE LITERATURE. THIS EVENT DOES NOT IDENTIFY ADDITIONAL HAZARDS OR MODIFY THE PROBABILITY AND SEVERITY OF EXISTING HAZARDS. THE IFU ADEQUATELY COMMUNICATES RISK. FIELD ASSURANCE WILL CONTINUE TO MONITOR SIMILAR COMPLAINTS TO DETERMINE IF ADDITIONAL ACTIONS ARE WARRANTED. 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 IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION. B5 - REMOVAL OF IDENTIFYING INFORMATION.
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 IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.
A PATIENT IN THE STUDY WAS HOSPITALIZED ON (B)(6) 2019 FOR A PLANNED SURGICAL PROCEDURE WHICH INCLUDED THE EXPLANT OF THE PREVIOUSLY IMPLANTED PHOTOFIX PATCH. PER THE OPERATIVE NOTE WHILE REMOVING THE OLD PHOTOFIX PERICARDIUM INFLAMMATORY TISSUE WAS OBSERVED. THE INFLAMED TISSUE WAS REMOVED DURING THIS PROCEDURE. ADDITIONAL INFORMATION FROM THE OPERATIVE NOTE RELAYS "THE ATRIAL FENESTRATION ON THE PHOTOFIX PATCH WAS GONE. IT WAS COVERED IN TISSUE. WE INCISED INTO THE ASD PATCH AND THERE WAS PURULENT MATERIAL THAT CAME OUT. SAMPLES WERE TAKEN FOR MICROBIOLOGY. WE ASPIRATED SOME FURTHER SAMPLES FOR STAT GRAM STAIN. STAT GRAM STRAIN [STAIN] REVELED INFLAMMATORY CELLS BUT NO ORGANISMS. THERE WAS A THICK RIND AROUND ALL THE PHOTOFIX. WE EXCISED IT AS MUCH AS POSSIBLE LEAVING SOME THAT WAS ATTACHED TO THE AV VALVE. MY SUSPICION IS THAT IS JUST AN INFLAMMATORY REACTION TO THE PHOTOFIX. THE PATIENT WAS WEANED FROM CARDIOPULMONARY BYPASS UNEVENTFULLY AND IN SINUS RHYTHM. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT IN STABLE CONDITION." PAST MEDICAL HISTORY: TRISOMY 21, TRACHEOMALACIA. FEEDING DIFFICULTY AND POOR WEIGHT GAIN S/P GT. CONGENITAL HYPOTHYROIDISM. PLAGIOCEPHALY. PATIENT STATUS UPDATE: THE PATIENT CONTINUED TO BE FOLLOWED AT THE HOSPITAL. HAD SUBSEQUENT CATHETERIZATIONS AND SURGERY FOR A BI-VENTRICULAR CONVERSION IN 2020. THE LATEST DATE PATIENT CAME IN FOR CARDIOLOGY FOLLOW-UP IS (B)(6) 2022, AND THE LATEST DATE CONTACTED HOSPITAL (ANOTHER DEPARTMENT) IS 11/28/22. NO ADDITIONAL INFORMATION FORTHCOMING. THE PRODUCT WILL NOT BE RETURNED. THIS INVESTIGATION IS RELEGATED TO PFP 6X8 LOT#: 171191.
A PATIENT IN THE PHOTOFIX RETRO-C STUDY WAS HOSPITALIZED ON (B)(6) 2019 FOR A PLANNED SURGICAL PROCEDURE WHICH INCLUDED THE EXPLANT OF THE PREVIOUSLY IMPLANTED PHOTOFIX PATCH. PER THE OPERATIVE NOTE WHILE REMOVING THE OLD PHOTOFIX PERICARDIUM INFLAMMATORY TISSUE WAS OBSERVED. THE INFLAMED TISSUE WAS REMOVED DURING THIS PROCEDURE. ADDITIONAL INFORMATION FROM THE OPERATIVE NOTE RELAY "THE ATRIAL FENESTRATION ON THE PHOTOFIX PATCH WAS GONE. IT WAS COVERED IN TISSUE. WE INCISED INTO THE ASD PATCH AND THERE WAS PURULENT MATERIAL THAT CAME OUT. SAMPLES WERE TAKEN FOR MICROBIOLOGY. WE ASPIRATED SOME FURTHER SAMPLES FOR STAT GRAM STAIN. STAT GRAM STRAIN [STAIN] REVELED INFLAMMATORY CELLS BUT NO ORGANISMS. THERE WAS A THICK RIND AROUND ALL THE PHOTOFIX. WE EXCISED IT AS MUCH AS POSSIBLE LEAVING SOME THAT WAS ATTACHED TO THE AV VALVE. MY SUSPICION IS THAT IS JUST AN INFLAMMATORY REACTION TO THE PHOTOFIX. THE PATIENT WAS WEANED FROM CARDIOPULMONARY BYPASS UNEVENTFULLY AND IN SINUS RHYTHM. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT IN STABLE CONDITION. PAST MEDICAL HISTORY: TRISOMY 21, TRACHEOMALACIA. FEEDING DIFFICULTY AND POOR WEIGHT GAIN S/P GT. CONGENITAL HYPOTHYROIDISM. PLAGIOCEPHALY. PATIENT STATUS UPDATE: THE PATIENT CONTINUED TO BE FOLLOWED AT THE HOSPITAL. HAD SUBSEQUENT CATHETERIZATIONS AND SURGERY FOR A BI-VENTRICULAR CONVERSION IN 2020. THE LATEST DATE PATIENT CAME IN FOR CARDIOLOGY FOLLOW-UP IS (B)(6) 2022, AND THE LATEST DATE CONTACTED HOSPITAL (ANOTHER DEPARTMENT) IS (B)(6) 2022. NO ADDITIONAL INFORMATION FORTHCOMING. THE PRODUCT WILL NOT BE RETURNED. THIS INVESTIGATION IS RELEGATED TO PFP 6X8 LOT#: 171191.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 957602 | PHOTOFIX PATCH - 6CM X 8CM | INTRACARDIAC PATCH OR PLEDGET BIOLOGICALLY DERIVED | PSQ | ARTIVION, INC. - KENNESAW | PFP 6X8 | 171191 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Other | ASPIRIN, LEVOTHYROXINE, MIRALAX| ASPIRIN, LEVOTHYROXINE, MIRALAX |