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During a routine review of the maude database, an event related to artivion product photofix was found (mdr report number ¿ (b)(4)).Additional information from the user facility was acquired.Date of initial surgery (b)(6) 2017, date of surgical intervention (b)(6) 2022, patient info ¿ male, 17 y/o at time of event.The following insert from the explant op notes was shared, ¿again, this previously was a photofix and we could see that there were innumerable ventricular septal defects throughout the entire middle of the patch with extremely thinned out patch material over the remaining intact part of the patch.There were at least 5 moderate to large ventricular septal defects within the patch material that were identified.The suture line was completely intact with no rupture of the suture line or separation of the edges of the patch from the ventricular rim of the ventricular septal defect.Therefore, this was clearly a patch degeneration.We completely resected all of the patch material and then replaced it with a non-artivion patch and a running 3-0 prolene suture.¿ the following information was requested but not provided, product details were not provided, patient medical history, pictures of the explanted product, operative notes for both implant and explant surgery, relevant laboratory test results, patient¿s vital signs and symptoms, patient outcome and product return.Currently, no additional information is forthcoming.
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According to a report submitted by the user facility directly to the fda, ¿background: a grievance was entered related to this issue last month.A cardiac surg patient had a procedure about 5 years ago performed by dr.Xx.During this procedure a photofix patch was used.The patient subsequently developed a baffle leak and it was discovered that the patch had degraded.Here is info from the record from about 5 years ago about the material used: inventory item: grft vasclr strtch 40cm 8mm #s0804 i#51460 model/cat number: s0804, serial number: (b)(6) manufacturer: w.L.Gore lot number: n/a size: 8 mm.Last month, dr.Xx operated on the patient to replace the degraded patch.Per operation note, "again, this previously was a photofix and we could see that there were innumerable ventricular septal defects throughout the entire middle of the patch with extremely thinned out patch material over the remaining intact part of the patch.There were at least 5 moderate to large ventricular septal defects within the patch material that were identified.The suture line was completely intact with no rupture of the suture line or separation of the edges of the patch from the ventricular rim of the ventricular septal defect.Therefore, this was clearly a patch degeneration.We completely resected all of the patch material and then replaced it with a [non-artivion] patch and a running 3-0 prolene suture.In dr.Xx¿s response to this grievance, he indicated that surgery team used to use this patch material called photofix.He stated that it has since been noted that this material degenerates when used as a patch material in the heart.The team was unaware of the degenerative process of this product when it was used in their patients.He stated that the company stated they were unaware of this problem when they put the product on the market.He has said that the product was fda approved.He stated that, to his knowledge, the facility never reported this issue to the fda.Dr.Xx stated he does not know the exact number of patients treated at the facility with this material and that obtaining that number would require a review of the or database and/or surgical database.Note: the family of this patient is aware of the issue with the photofix patch and is focused on facility reporting this issue to the fda and showing them evidence of the medsun report.Assessment: while this particular patch degradation incident may not meet the specific fda criteria for mandated reporting the fda does highly encourage reporting of issues such as these.Reporting this material defect is a reasonable action and would help to satisfy this parents request for evidence the facility has reported it.Also, finding out if the fda has placed any recalls or alerts on this photofix product would help the facility to determine if we need to identify the other patients who received this patch to notify their cardiologists and/or families.Recommendation: report this material defect to the fda.Identify if there have been any recalls or alerts about this product that would guide the facility¿s communications with other patients who have potentially been impacted.Please notify patient safety and ope if there are recalls and/or alerts related to this product." this investigation is relegated to pfp6x8 lot 12030918, pfp6x8 lot 11020818, pfp6x8 lot 11022218 and pfp6x8 lot 11020218.The product will not be returned to the manufacturer for evaluation.The following additional information regarding this event was received.Patient medical history as of may 15, 2018, patient operative notes for implant surgery may 15, 2022, operative notes for the explant surgery march 22, 2022 and patient anatomical measurements as of march 22, 2022.The manufacturing records for pfp6x8 lot # 11020218 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.The manufacturing records for pfp6x8 lot # 11020818 were reviewed by quality assurance/quality control (qa/qc) 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.The manufacturing records for pfp6x8 lot # 11022218 were reviewed by quality assurance/quality control (qa/qc) 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.The manufacturing records for pfp6x8 lot # 12030918 were reviewed by quality assurance/quality control (qa/qc) 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.A review of the available information was performed.The individual from the user facility that entered this information into the fda database referenced a previous surgery for this patient erroneously.The implant of the gore patch was in 2017, the photofix patch(es) were implanted in 2018.All information artivion has referenced regarding this event has been based on the 2018 surgery where the four photofix patches were implanted.Excerpt from operative notes from medsun dated 5/15/2018: "per op note, "again, this previously was a photofix, and we could see that there were innumerable ventricular septal defects throughout the entire middle of the patch with extremely thinned out patch material over the remaining intact part of the patch.There were at least 5 moderate to large ventricular septal defects within the patch material that were identified.The suture line was completely intact with no rupture of the suture line or separation of the edges of the patch from the ventricular rim of the ventricular septal defect.Therefore, this was clearly a patch degeneration.We completely resected all of the patch material and then replaced it with a [non-artivion] patch and a running 3-0 prolene suture.'111 there is currently no information available regarding a pathologic evaluation of the explanted patch.Additionally, there is no information regarding concerns of an immune response and no tissue sample was returned for evaluation.The following additional information was received from the user facility and is in the associated file: medical history (5/14/2018), operative notes (5/15/2018) and operative notes {3/22/2022).According to the medical history {5/14/2018), this patient was a 13-year-old male with complex congenital heart disease and has undergone at least one (2017) prior corrective surgery prior to presenting for the surgical repair in 2018.No known allergy to bovine products is listed.Specific details of the operation can be found in the above referenced operative notes provided for this file.In summary, multiple (4) photofix patches were implanted in a variety of anatomic locations to complete the cardiac reconstruction.The procedure was successful, and patient was brought to the intensive care unit in stable condition.Note: as already stated, multiple photofix patches were used in a variety of anatomic locations.The notes do not specify which patch was used in each specific location.As such, we are not able to correlate any specific patch/lot to the reported events.There is currently no information on the patient¿s clinical course until the readmission in 2022.On march 3/22/3022, approximately 4.5 years 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 post-operative 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 patient presented with post-operative degradation but may be the result of an inflammatory 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 numbers for the associated patches were provided, and all devices 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 2018.Inflammation and patch degeneration 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 pericardia! 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.No further action is required.The photofix decellularized bovine pericardium a/dfmea and pfmea were reviewed.The reported event is addressed.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.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.Based on the available information, a definitive root cause for this event cannot be determined.There is insufficient information available to determine the precise cause and effect relationship between the photofix product and the reported adverse events.Additionally, without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.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.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.Artivion will continue to monitor similar complaints to determine if additional actions are warranted; however, no further action is warranted at this time.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.
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