MAUDE Adverse Event Report: ARTIVION, INC. PHOTOFIX DECELLULARIZED BOVINE PERICARDIUM

Model Number	PFP 6X8
Medical Device Problem Codes	Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	01/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
According to the report, the patient had a photofix patch implanted on (b)(6) 2022 for a ventricular septal defect (vsd) closure, pulmonary artery debanding, pulmonary artery patch reconstruction and dcrv release.Five months post-procedure, on 16january2023 the patient presented with vsd patch leak and the pulmonary valve was thickened and destroyed.Pannus was noted around the photofix.The photofix was explanted.
Additional Manufacturer Narrative
The manufacturing records for pfp6x8 lot 11070121 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.During the investigation no non-conformances or deviations were found to be related to the complaint.According to the initial report, "the patch had severe reaction when put on one pt.[patient] on the pulmonary artery side and cause severe obstruction few months after implantation." additional information including operative notes were received.According to this additional information, "the patient has history of (1) coarctation of aorta repair+ pulmonary artery banding at 2 days of age on (b)(6) 2021 and on (b)(6) 2022 when he was 11 mos & 2 days old for (2) ventricular septa/ defect (vsd) closure + pulmonary artery debanding+ pulmonary artery patch reconstruction+ dcrv release.They closed the ventricular septal defect with photofix patch and pulmonary artery reconstruction with photofix patch.Then after 5 months of the surgery, on (b)(6) 2023, the patient came with vsd patch leak and the pulmonary valve was thickened and destroyed.On (b)(6) 2023 -where we found residual ventricular septal defect & severe thickening of the nearby pulmonary valve- we did (3) residual vsd patch closure + transannular patch across the right ventricular outflow tract to pulmonary artery with matrix patch." the operative notes noted "significant pannus formation around the photofix patch in the vsd position." the patch was explanted and replaced with another device.A complaint and recall query was performed to identify previously reported complaints or recalls associated with lot 11070121.No complaints or recalls associated with this lot were identified.Note: per the operative notes provided the photofix patch was used in two different anatomic locations/repairs.There is currently no information on the patient¿s clinical course since the initial report in december 2023.Per the operative notes and email communications, approximately 5 months post implant, the patient underwent another cardiac reconstruction which included the explant of photofix as described in the original notification listed above.Specific details of the operation can be found in the above referenced operative notes provided for this file.No explant pathology is currently available, and no tissue was returned for evaluation.Details surrounding the patient¿s postoperative recovery are currently unknown.The use of pericardial patches for congenital cardiac reconstructions is well established, and includes the use of autologous fresh pericardium, autologous glutaraldehyde-fixed pericardium, synthetic patches, glutaraldehyde-fixed xenografts as well as the photo-oxidized (non-glutaraldehyde fixed, photofix) xenograft patch.(1) adverse events, as reported in the literature include, but are not limited to aneurysm, calcification, degeneration, dehiscence, infection, inflammatory response, rupture and stenosis.The publication by baird, et al.(2) 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.Degeneration of the patch material as indicated by loss of collagen fibre 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.¿ this is an excerpt from the full histologic evaluation previously reported by majeed et.Al.(3) which compares the outcomes with samples of explanted photofix (n=8, listed above), glutaraldehyde-preserved autologous pericardium (n=8) and glutaraldehyde preserved bovine pericardium (n=3) after use in pediatric heart surgery.The number of patients receiving the glutaraldehyde-process bovine pericardium were too small for statistical analysis, albeit all 3 samples showed some level of degeneration.Inflammation and tissue degeneration were also documented in the photofix bovine pericardium as well as the autologous pericardium samples.The following was noted in the photofix samples: inflammation was no more than moderate and degeneration was moderate or more in only two cases.The authors comment that ¿the longer duration in situ might explain the greater tissue degeneration in the photofix pericardium but not the greater inflammatory response, which appeared early and remained relatively constant over the duration of the observation period.¿ it is unclear why this particular patient presented with post-operative severe reaction, pannus formation and obstruction but may be the result of an inflammatory or immune response related to the duration in situ, systemic pressure or the anatomical location as theorized by baird and majeed.This, however, cannot be confirmed without pathology results or tissues for evaluation.Potential adverse events associated with the use of photofix include adhesion, epicardial inflammatory reactions, and rejection and are included in the instructions for use (ifu).As shown in the literature, in this patient population, explant is a known outcome that can occur at various times post implant regardless of the type of patch material used.Lot number for the associated patch was provided, and the device listed above met all criteria for final device.The photofix manufacturing process includes 100% visual inspection prior to final packaging.Additionally, the operating staff did not report any notable defects associated with the patches at the time of the implant in 2022.Inflammation and rejection (immune response) have been reported to occur with several fixed tissue types (1-3).The explanted samples were not returned for evaluation, and no pathology report was provided for consideration in the root cause of these events.Albeit without a pathologic evaluation on these reported explants, the relation to a biologic process (inflammatory or immune reaction) cannot be determined.The ifu lists potential adverse events.As shown by the literature, these are not unexpected outcomes with the use of pericardial patches for congenital cardiac reconstructions although they appear to be of low occurrence.There is insufficient information available to determine the precise cause and effect relationship between the photofix product and the reported adverse events.The photofix decellularized bovine pericardium a/dfmea was reviewed.The reported event is addressed in hazard step/item # a.1 - 1a and 1b.The photofix decellularized bovine pericardium pfmea was reviewed.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 residual risk is acceptable.References: (1) pande s, sharma jk, siddartha cr, et al., fresh autologous pericardium to reconstruct the pulmonary valve at the annulus when tetralogy of fallot requires a transannular patch at midterm.Tex heart inst j.2016;43(3):207-213.Doi:10.14503/thij-14-4609.(2) baird, c.W., myers, p.O., piekarski, b., borisuk, m., majeed, a., emani, s.M., del nido, p.J.(2017).Photo-oxidized bovine pericardium in congenital cardiac surgery: single-centre experience.Interactive cardiovascular and thoracic surgery, 24(2), 240¿244.(3) majeed a, baird c, borisuk mj, et.Al., histology of pericardial tissue substitutes used in congenital heart surgery.Pediatric and developmental pathology 19, 383¿388, 2016.Doi: 10.2350/15-08-1696-oa.1.This report is being submitted as required 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 DECELLULARIZED BOVINE PERICARDIUM
• Common Device Name: DECELLULARIZED BOVINE PERICARDIUM
• Manufacturer (Section D): ARTIVION, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer (Section G): ARTIVION, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd. nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 18476596
• Report Number: 1063481-2024-00001
• Device Sequence Number: 17841089
• Product Code: PSQ
• UDI-Device Identifier: 00877234000621
• UDI-Public: 00877234000621
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K183635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 06/26/2023
• Device Model Number: PFP 6X8
• Device Lot Number: 11070121
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2023
• Supplement Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 15 MO
• Patient Sex: Male
• Patient Weight: 10 KG