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

Model Number PFP0.8X8

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.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 the initial report, the surgeon has experienced a lot of bleeding after releasing the clamp following implantation of photofix 0.8x8 patch.The bleeding led to prolonged surgeries, extra sutures, and more hemostatic agents to stop it.The surgeon has experienced this event twice.

Manufacturer Narrative

A review of the available information was performed.The surgeon was not happy with 0.8cm x 8cm photofix patch.During the conversation, it was mentioned that they had experienced a lot of bleeding after releasing clamp.The surgeon had experienced this more than once.Both patients were on an antiplatelet medication and had not stopped the medication prior to surgery.The bleeding led to prolonged surgeries, extra sutures, and more hemostatic agents to stop it.No additional information is available regarding the surgical procedures, extent of concomitant procedures, quality of the native tissue, or any post-operative impact.The reported patch size is generally used as arterial patches associated with carotid endarterectomy procedures.Synthetic and bovine patches are well established patch materials used for this procedure.Suture line bleeding is a known intra-operative variable and can to be dependent upon patch material, suture material, quality of native arterial wall (extent of endarterectomy and arterial disease) and intraoperative blood modifiers.As a result, reported event rates are variable.In the series by marien, et al.(2002), bleeding from suture lines was significantly less in the bovine pericardium vs synthetic patch arm (14% vs 55%, p<0.001).The precise cause of the intraoperative bleeding is unknown, although intraoperative suture line bleeding is a known surgical variable associated with surgical procedures.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.There is no indication that an error or deficiency occurred and the ifu adequately communicates risk.All risks identified have been mitigated as far as possible and residual risk is acceptable.Reference 1063481-2019-00066 for similar reported event.No further action recommended.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 PATCH
• Type of Device: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 9251748
• MDR Text Key: 173762750
• Report Number: 1063481-2019-00067
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• PMA/PMN Number: K183635
• 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: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: PFP0.8X8
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/08/2019
• Date Manufacturer Received: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention