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

Model Number PFP6X8

Device Problem Insufficient Information (3190)

Patient Problem Wound Dehiscence (1154)

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, surgeon reported that he noticed photofix was dehisced when evaluating a patient during follow up.

Manufacturer Narrative

According to initial reports, during a follow-up appointment with the patient, the surgeon reported the photofix patch used in surgery was dehisced.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.No tissue was returned for evaluation.A review of manufacturing records could not be performed as a definitive lot/serial number was not provided by the complainant.Tissue damage leading to blood leakage through holes and tears is a known adverse event.In their series of 364 patients, baird, et al.(2017), report a single dehiscence occurring at 6 years post-operatively.(1) as the surgeon is a co-author on this referenced manuscript, it is unclear if these may be the same event; and we cannot conclude with no additional information.Given this data, dehiscence with the use of photofix can occur, but appears to be a rare event.The cause of the described patch dehiscence is unknown.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.No further action is required at this time.The instructions for use were reviewed and found to be adequate.No new risks were identified during the course of the complaint investigation.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.

Event Description

According to initial reports, surgeon reported that he noticed photofix was dehisced when evaluating a patient during follow up.

• Brand Name: PHOTOFIX PATCH - DECELLULARIZED BOVINE PERICARDIUM PATCH
• Type of Device: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd; kennesaw GA 30144
• MDR Report Key: 8711525
• MDR Text Key: 148403487
• Report Number: 1063481-2019-00034
• 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: 09/03/2019

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 Model Number: PFP6X8
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/07/2019
• Initial Date Manufacturer Received: 06/07/2019
• Initial Date FDA Received: 06/19/2019
• Supplement Dates Manufacturer Received: 06/07/2019
• Supplement Dates FDA Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other