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

Model Number 21 CFR 870.3470

Device Problems Material Disintegration (1177); Product Quality Problem (1506)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

There have been a series of cases at (b)(6) hospital (b)(6) where the fda approved product (under the 510k clearance pathway): photofix decellularized bovine pericardium (intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene) has been noted to have important loss in integrity to the point of recapitulating the original intracardiac lesions and in several cases requiring reoperation (via sternotomy) to repair.In the past 4 months, there have been 4 cases of photofix patches which have demonstrably failed (echocardiographically) requiring reoperation.Upon direct inspection during the reoperation, the photofix patches appeared to have been largely not intact and best described as disintegrated (loss of patch material).The patch failures could not be attributed to patient factors, infection, or surgical technique failures (i.E., suture failure).At our center, we have ceased to utilize photofix patches.We are currently undergoing a more extensive review of our patients who have undergone cardiac surgery utilize photofix patches.Our aim is to understand the potential incidence of patch failure (including patients who have experience patch failures but not to the degree as to requiring reoperations) and collaborate with other centers that may have similar experiences.Fda safety report id # (b)(4).

• Brand Name: PHOTOFIX DECELLULARIZED BOVINE PERICARDIUM PHOTOFIX PATCHES
• Type of Device: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• Manufacturer (Section D): CRYOLIFE, INC.
• MDR Report Key: 14676996
• MDR Text Key: 293960951
• Report Number: MW5110279
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/09/2022
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21 CFR 870.3470
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/10/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Prefer Not To Disclose