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

Model Number PFP0.8X8

Device Problem Insufficient Information (3190)

Patient Problems Exsanguination (1841); Hematoma (1884)

Event Date 02/04/2019

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, the patient had surgery on (b)(6) 2019.A pfpo.8x8, lot #31091818 was used.The patient came to the emergency department on (b)(6) 2019.Surgeon took the patient urgently to surgery at 07:45 and removed the hematoma and repaired the artery with a lemaitre xenosure 1x6.There were no signs of infection; however, part of the original photofix patch was disintegrated.

Manufacturer Narrative

The manufacturing records for the pfp0.8x8, lot # 31091818 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.The product was not returned for evaluation.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.The source of the described patch disintegration is unknown.Tissue damage leading to blood leakage through holes and tears is a known adverse event.The photofix manufacturing process includes 100% visual inspection prior to final packaging.The relationship between the reported event and photofix cannot be determined without additional information.Based on the information available at the time of this report, it is not possible to determine a definitive root cause of the observed complications.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, the patient had surgery on (b)(6) 2019.A pfpo.8x8, lot #31091818 was used.The patient came to the emergency department on (b)(6) 2019.Surgeon took the patient urgently to surgery at 07:45 and removed.There were no signs of infection, however, part of the original photofix patch was disintegrated.

Event Description

According to initial reports, the patient had surgery on (b)(6) 2019.A pfpo.8x8, lot #31091818 was used.The patient came to the emergency department on (b)(6) 2019.Surgeon took the patient urgently to surgery at 07:45 and removed the hematoma and repaired the artery.There were no signs of infection, however, part of the original photofix patch was disintegrated.

Manufacturer Narrative

The manufacturing records for the pfp0.8x8, lot # 31091818 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.No tissue was returned for evaluation.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.The source of the described patch disintegration is unknown.According to the available information, there were no signs of infection and part of the original patch was disintegrated.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.Root cause for the source of the hematoma and described patch disintegration is unknown.Tissue damage leading to blood leakage through holes and tears is a known adverse event.The photofix manufacturing process includes 100% visual inspection prior to final packaging.The relationship between the reported event and photofix cannot be determined without additional information.Based on the information available at the time of this report, it is not possible to determine a definitive root cause of the observed complications.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 DECULLARIZED 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: 8339170
• MDR Text Key: 136133170
• Report Number: 1063481-2019-00005
• 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,Followup
• Report Date: 05/04/2019

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 Operator: No Information
• Device Expiration Date: 09/16/2020
• Device Model Number: PFP0.8X8
• Device Lot Number: 31091818
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/05/2019
• Initial Date Manufacturer Received: 02/05/2019
• Initial Date FDA Received: 02/14/2019
• Supplement Dates Manufacturer Received: 02/05/2019; 02/05/2019
• Supplement Dates FDA Received: 05/04/2019; 05/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention