MAUDE Adverse Event Report: CRYOLIFE, INC. ¿ KENNESAW PHOTOFIX DECELLULARIZED BOVINE PERICARDIUM; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Model Number PFP 6X8

Device Problem Insufficient Information (3190)

Patient Problem Thrombus (2101)

Event Date 02/27/2019

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, patient experienced hypersensitivity thought to be attributed to photofix.Date of implant (b)(6) 2018.Additional information received.The patient ended up having a large clot form on the inter-atrial baffle patch during the month of dec despite being on therapeutic coumadin.The clot had to be surgically removed in (b)(6) 2019.Then, despite running his inr even higher in the inr 2.5-4 range on coumadin with 325 mg aspirin, the growth has continued to grow on his atrial baffle and it changes every week, so we now have to remove the entire baffle for take down to use a different type of patch material.

Manufacturer Narrative

The manufacturing records for pfp 6x8 lot number 11062618 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.According to initial reports, patient experienced hypersensitivity thought to be attributed to photofix.Date of implant (b)(6) 2018.¿the patient ended up having a large clot form on the inter-atrial baffle patch during the month of december despite being on therapeutic coumadin and the clot was removed early (b)(6) 2019.The clot had to be surgically removed in january.Then despite running his inr even higher since then in the inr 2.5-4 range on coumadin with 325 mg aspirin the growth has continued to grow on his atrial baffle and it changes every week, so we now have to remove the entire baffle for take down to use a different type of patch material.This is why we want to test the bovine patch to his skin and see what happens since we do not understand why this baffle is developing this growth/thickening/clot like formation despite supra therapeutic inr levels.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.Patch testing was negative for both bovine and vortex patches.While this doesn¿t mean there was no immunologic reason for the clotting (this patch testing has obviously not been standardized), there is no evidence of an obvious hypersensitivity.No tissue was returned for evaluation.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.The specific signs/symptoms that suggested an allergic reaction are unknown; however the negative skin test suggests that a hypersensitivity to the patch is unlikely.The presence of ¿a clot¿ adjacent to the patch is non-specific and does not suggest an inherent problem with the patch.Thrombus may form as a result of turbulent blood flow, however echocardiographic data regarding blood flow pattern around the baffle is not available.Root cause for this event is unknown.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 cryolife is accurate or has been confirmed by cryolife.

Event Description

According to initial reports, patient experienced hypersensitivity thought to be attributed to photofix.Date of implant (b)(6) 2018.Additional information received.The patient ended up having a large clot form on the inter-atrial baffle patch during the month of dec despite being on therapeutic coumadin.The clot had to be surgically removed in (b)(6) 2019.Then, despite running his inr even higher in the inr 2.5-4 range on coumadin with 325 mg aspirin, the growth has continued to grow on his atrial baffle and it changes every week, so we now have to remove the entire baffle for take down to use a different type of patch material.

• Brand Name: PHOTOFIX DECELLULARIZED BOVINE PERICARDIUM
• Type of Device: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• Manufacturer (Section D): CRYOLIFE, INC. ¿ KENNESAW; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 8374288
• MDR Text Key: 137274508
• Report Number: 1063481-2019-00008
• 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: 05/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• 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: 11062618
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/25/2019
• Date Manufacturer Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention