PHOTOFIX PATCH - 6CM X 8CM

Report

Report Number: 1063481-2021-00001
Event Type: Injury
Date Received: January 12, 2021
Date of Event: December 15, 2020
Report Date: February 24, 2021
Manufacturer: CRYOLIFE, INC. - KENNESAW
Product Code: PSQ
PMA / PMN Number: K183635
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: UT, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

CORRECTED DATA: LOT NUMBER IS 12040120, NOT K183635, AS REPORTED IN THE INITIAL MDR IN BOX D4. CLINICAL/MEDICAL REVIEWED THE AVAILABLE INFORMATION. PER THE INFORMATION AVAILABLE IT APPEARS THAT A SINGULAR 6X8 PIECE OF PHOTOFIX WAS DISSECTED INTO SMALLER SECTIONS AND USED TO REPAIR SEVERAL ANATOMIC LOCATIONS ASSOCIATED WITH COMPLEX CONGENITAL HEART REPAIR AND RECONSTRUCTION OF THE RIGHT AND LEFT PULMONARY ARTERIES, THE TRANSANNULAR INCISION AND TO CLOSE BOTH AN ASD AND A VSD IN THE SAME PATIENT AND DURING THE SAME PROCEDURE. THIS INITIAL SURGERY OCCURRED ON 6/11/2020. APPROXIMATELY 6-MONTHS POSTOPERATIVE, THE PATIENT UNDERWENT A SECONDARY PROCEDURE ON 12/15/2020 DUE TO COMPLICATIONS OF PHOTOFIX THICKENING AND IMPAIRED PERFORMANCE OF THE PULMONARY ARTERY WHICH RESULTED IN THE EXPLANT OF THE PHOTOFIX PATCH FROM THE LEFT PULMONARY ARTERY. THE EXPLANTED TISSUE WAS RETURNED TO CRYOLIFE FOR FURTHER EVALUATION. A SAMPLE EVALUATION WAS PERFORMED IN THE FIELD ASSURANCE LAB ON 08-JAN-2021. THE SAMPLE WAS RECEIVED IN A CLEAR JAR CONTAINING FORMALIN. THE SEGMENT WAS VISUALLY INSPECTED BY PHOTOFIX SMES. THE SEGMENT COULD NOT BE SAFELY MEASURED WITH THE AVAILABLE EQUIPMENT DUE TO ITS BIOHAZARDOUS EXPOSURE. IT WAS UNCLEAR IF THE SEGMENT WAS SOLELY PHOTOFIX, BUT IT DID APPEAR TO LOOK THICKER. THE SAMPLE WAS SENT OFF TO PATHOLOGY FOR FURTHER EXAMINATION. PER THE PATHOLOGY REPORT, THE DIMENSIONS AND DESCRIPTION OF THE SAMPLE THAT WAS RECEIVED IS A 2.2 X 0.5 X 0.3 CM, IRREGULAR, WHITE, RUBBERY PIECE OF TISSUE WITH A SMALL SUTURE AT ONE MARGIN. THE FINDINGS WERE OF CHRONIC AND ACUTE INFLAMMATORY REACTION TO INTRODUCE(D) FOREIGN BODY CONSISTENT WITH PHOTOFIX TISSUE. 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. (2) 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 ONLY THIS ONE APPLICATION SITE IN THE LEFT PULMONARY ARTERY IS ASSOCIATED WITH POST-OPERATIVE ¿REMODELING¿ BUT MAY BE RELATED TO THE SYSTEMIC PRESSURE OR THE ANATOMICAL LOCATION AS THEORIZED BY BAIRD. POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF PERICARDIUM INCLUDE: ADHESION, EPICARDIAL INFLAMMATORY REACTIONS, AND REJECTION AND ARE INCLUDED IN THE INSTRUCTIONS FOR USE. THE CAUSE OF THE DESCRIBED EVENTS IS UNKNOWN. HOWEVER, HISTOPATHOLOGIC EXAMINATION SHOWS A COMBINED ACUTE AND CHRONIC INFLAMMATORY REACTION. THE PHOTOFIX MANUFACTURING PROCESS INCLUDES 100% VISUAL INSPECTION PRIOR TO FINAL PACKAGING. THERE IS INSUFFICIENT INFORMATION AVAILABLE TO DETERMINE THE PRECISE CAUSE AND EFFECT RELATIONSHIP BETWEEN THE PHOTOFIX PRODUCT AND THE REPORTED ADVERSE EVENT. RISK MANAGEMENT REVIEWED THE AVAILABLE INFORMATION. THE PHOTOFIX DECELLULARIZED BOVINE PERICARDIUM WAS REVIEWED. THE REPORTED EVENT IS ADDRESSED. THE PHOTOFIX DECELLULARIZED BOVINE PERICARDIUM PFMEA WITHIN RM-WAS REVIEWED. THE INSTRUCTIONS FOR USE WERE REVIEWED AND ARE FOUND TO BE ADEQUATE. NO NEW RISKS WERE IDENTIFIED DURING THE COURSE OF THE RISK MANAGEMENT DEPARTMENTAL COMPLAINT INVESTIGATION. ALL RISKS IDENTIFIED HAVE BEEN MITIGATED AS FAR AS POSSIBLE AND RESIDUAL RISK IS ACCEPTABLE. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE FOR THIS EVENT IN 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. ALL LOTS PASSED FUNCTIONAL TESTING AND MET RELEASE SPECIFICATIONS. THERE IS NO INDICATION THAT AN ERROR OR DEFICIENCY OCCURRED AT CRYOLIFE AND ALL RISKS IDENTIFIED HAVE BEEN MITIGATED AS FAR AS POSSIBLE AND RESIDUAL RISK IS ACCEPTABLE. 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 CRYOLIFE IS ACCURATE OR HAS BEEN CONFIRMED BY CRYOLIFE.

Additional Manufacturer Narrative · 1

THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

Description of Event or Problem · 1

ACCORDING TO THE INITIAL REPORT, "PATIENT [BROUGHT] BACK FOR RE OPERATION DUE TO COMPLICATIONS OF PHOTOFIX THICKENING AND IMPAIRED PERFORMANCE IN THE PULMONARY ARTERY." A HANDWRITTEN NOTE WITH ADDITIONAL INFORMATION REGARDING THE OPERATION WAS ATTACHED TO THE PRODUCT RETURN. IT STATED: ORIGINAL PROCEDURE: (ON (B)(6) 2020) PA [PULMONARY ARTERY] PLASTY, TETRALOGY OF FALLOT REPAIR, ASD [ATRIAL SEPTAL DEFECT] CLOSURE. MULTIPLE PIECES CUT FROM SAME PHOTOFIX PATCH. USED TO AUGMENT RIGHT AND LEFT PULMONARY ARTERIES, AS WELL AS TRANSANNULAR INCISION, AND TO CLOSE ASD AND VSD [VENTRICULAR SEPTAL DEFECT]. PIECE EXPLANTED FROM LPA [LEFT PULMONARY ARTERY] ON SECOND PROCEDURE (ON (B)(6) 2020). PA'S HAD TO BE REPATCHED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
50837	PHOTOFIX PATCH - 6CM X 8CM	PHOTOFIX DECELLULARIZED BOVINE	PSQ	CRYOLIFE, INC. - KENNESAW	PFP 6X8	12040120

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other