MAUDE Adverse Event Report: CRYOLIFE, INC. PHOTOFIX DECELLULARIZED BOVINE PERICARDIUM (RECTANGLE) PFP6X8 6 CM X 8 CM

Model Number PFP 6X8

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inflammation (1932)

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to the initial report received, "physician said he has noted on a few occasions early swelling of the photofix that then diminishes over time.He did have a case that on redo surgery he noted that the photofix patch was 'significantly swollen and pulled away from the aortotomy.' physician states concern over swelling.

Manufacturer Narrative

Additional information including patient medical history and surgical notes for the initial surgery or the re-operation are not available for consideration in this complaint evaluation.Details surrounding the patient¿s post-operative recovery are also unknown.Limited information is available which indicate this patch was used for pa (pulmonary artery) reconstruction and the treatment was to perform a fontan procedure 2 years after the implant at the time of the explant.As such, it is plausible that the patch material was initially used in a norwood or a glen procedure in a patient with congenital heart disease.The initial reported event of ¿swollen and pulled away from the aortotomy¿ is still ambiguous and the additional descriptions of ¿completely delaminated with significant scar build up¿ cannot be addressed as no tissue was returned for evaluation.The use of bovine pericardial patches for congenital cardiac reconstructions is well established.Although literature specific to photofix is limited, bergoënd et al (2010) published a case report wherein the pulmonary artery was reconstructed using cardiofix pericardium (carbomedics, inc) without any reported complications at clinical follow-up 8 years postoperatively.(1) additionally, baird, et al.(2017) report on the use of photofix in 383 operations including both right and left sided congenital cardiac reconstructions with minimal adverse events, and none described as above.(2) given the limited clinical data to date, it appears these reported events can occur in conjunction with the use of photofix but have not been reported in the literature to date.As no tissue was returned for evaluation, no correlation to the cause of the swelling or the delamination can be determined at this time.The photofix decellularized bovine pericardium a/dfmea was reviewed.The reported event is addressed.The photofix decellularized bovine pericardium pfmea 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.The occurrence of identified risks did not increase.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.

• Brand Name: PHOTOFIX DECELLULARIZED BOVINE PERICARDIUM (RECTANGLE) PFP6X8 6 CM X 8 CM
• Type of Device: PHOTOFIX DECELLULARIZED BOVINE
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 10542189
• MDR Text Key: 207223627
• Report Number: 1063481-2020-00020
• Device Sequence Number: 1
• Product Code: PSQ
• Combination Product (y/n): N
• PMA/PMN Number: K183635
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: PFP 6X8
• Device Catalogue Number: PFP 6X8
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other