MAUDE Adverse Event Report: CRYOLIFE, INC. PHOTOFIX DECELLULARIZED BOVINE PERICARDIUM (RECTANGLE) 6 CM X 8 CM; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Model Number PFP6X8

Device Problem Insufficient Information (3190)

Patient Problem Reaction (2414)

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 initial reports, there is a concern that the patient is having an allergic reaction to the patch.Photofix was used to create a patch that extended from the svc down onto the right atrium.

Event Description

According to initial reports, there is a concern that the patient is having an allergic reaction to the patch.Photofix was used to create a patch that extended from the svc down onto the right atrium.

Manufacturer Narrative

The manufacturing records for the pfp6x8 lot no.11032218 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.A review of the available information was performed.Additional information including patient medical history and surgical notes are not available for consideration in this complaint evaluation.Details surrounding the patient¿s post-operative recovery are also unknown.It cannot be determined whether the patient has a bovine allergy.The reason for the patch explant is unknown.Additionally, the specific signs/symptoms that suggested an allergic reaction are also unknown.However, the absence of significant inflammation on the histopathology examination argues against an immune (allergic) reaction.The presence of fibrin adjacent to the patch is non-specific and does not suggest an inherent problem with the patch.Photofix is contraindicated in patients that exhibit sensitivity to materials of bovine origin.Based on pre-clinical data, biocompatibility testing, published literature, and experience data, as well as the ongoing risk mitigation and post market surveillance activities, photofix performs safely with an acceptable benefit: risk profile in the appropriate patient population.The relationship between the patient¿s symptoms and photofix cannot be determined without additional information.Root cause for this event is unknown.No additional action is required.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) 6 CM X 8 CM
• Type of Device: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd; kennesaw GA 30144
• MDR Report Key: 8289415
• MDR Text Key: 134490732
• Report Number: 1063481-2019-00004
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• PMA/PMN Number: K172085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 03/13/2020
• Device Model Number: PFP6X8
• Device Catalogue Number: N/A
• Device Lot Number: 11032218
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/29/2019
• Date Manufacturer Received: 01/29/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 3 YR