MAUDE Adverse Event Report: ARTIVION, INC. ¿ KENNESAW PHOTOFIX UNKNOWN CONFIGURATION; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Model Number PF UNK

Device Problem Material Disintegration (1177)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

A fda medwatch report was forwarded.The event is described below: there have been a series of cases at (b)(6) hospital (b)(6) where the fda approved product (under the 510k clearance pathway): photofix decellularized bovine pericardium (intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene) has been noted to have important loss in integrity to the point of recapitulating the original intracardiac lesions and in several cases requiring reoperation (via sternotomy) to repair.In the past 4 months, there have been 4 cases of photofix patches which have demonstrably failed (echocardiographically) requiring reoperation.Upon direct inspection during the reoperation, the photofix patches appeared to have been largely not intact and best described as disintegrated (loss of patch material).The patch failures could not be attributed to patient factors, infection, or surgical technique failures (i.E., suture failure).At our center, we have ceased to utilize photofix patches.We are currently undergoing a more extensive review of our patients who have undergone cardiac surgery utilize photofix patches.Our aim is to understand the potential incidence of patch failure (including patients who have experience patch failures but not to the degree as to requiring reoperations) and collaborate with other centers that may have similar experiences.Fda safety report id # (b)(4).

Manufacturer Narrative

Multiple attempts to obtain additional information have gone unmet.No additional information forthcoming.The manufacturing records could not be reviewed as no lot numbers were provided and the exact surgery dates are unknown.No additional information forthcoming, as such information including patient medical histories and surgical notes for the initial surgeries, or the re-operations are not available for consideration in this complaint evaluation.We do not know when the patches were implanted, or the exact duration prior to explant.No explant pathology reports are available, and no tissue was returned for evaluation.Details surrounding the patient¿s post-operative recoveries are also unknown.The reporting physician is [surgeon] and is associated with [user facility].Although the exact indication for use of these patches remains unknown, given the report was filed from a children¿s hospital, it is highly probable they were used during congenital cardiac reconstructions.The use of pericardial patches (autologous, synthetic and xenograft) for congenital cardiac reconstructions is well established.Specific to photofix, 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.(1) ¿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.Degeneration of the patch material as indicated by loss of collagen fiber structure was absent or minimal in 2 cases, mild in 4 cases and moderate in 2 cases.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 these particular patches presented with postoperative degradation 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.As shown in the literature, explant is not an unexpected outcome and can occur at various times post implant.The cause of the described events is unknown.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.The photofix decellularized bovine pericardium risk management file was reviewed.The reported event is addressed.No samples were returned, and lot numbers are unknown.The cause of the described events is unknown.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.Based on the available information, the root cause is unknown.There is no indication that an error or deficiency occurred at artivion 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 artivion is accurate or has been confirmed by artivion.

• Brand Name: PHOTOFIX UNKNOWN CONFIGURATION
• Type of Device: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• Manufacturer (Section D): ARTIVION, INC. ¿ KENNESAW; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer (Section G): ARTIVION, INC. ¿ KENNESAW; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd. nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 15039285
• MDR Text Key: 296045504
• Report Number: 1063481-2022-00011
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PF UNK
• Device Lot Number: 11123019; 21102119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other