MAUDE Adverse Event Report: CRYOLIFE, INC. PHOTOFIX PATCH - 2CM X 9CM; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Model Number PFP2X9

Device Problem Insufficient Information (3190)

Patient Problems Fluid Discharge (2686); No Code Available (3191)

Event Date 10/29/2019

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.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

Patient enrolled in photo-v study.The patient was implanted with a photofix patch as part of right femoral endarterectomy procedure on (b)(6) 2019.On (b)(6) 2019 the patient was seen and noted to have clear serous drainage from a pin hole opening noted mid incision.The right groin is healed.No erythema, no peri wound edema, no skin maceration, non tender, no induration.This patient has what appears to be a lymphocele in the early postoperative period.

Manufacturer Narrative

A review of the available information was performed.On (b)(6) 2019 the patient was implanted with a 2x9cm photofix patch (which was modified to a smaller size to suit the anatomy) as part of a right femoral endarterectomy (fea).On (b)(6) 2019, the patient presented with serous drainage from the right groin, which was referred to as a small lymphocele.The event was further described by the site: ¿patient requested an urgent visit stating the ¿my groin is always wet.¿ patient was seen and noted to have clear serous drainage from a pin hole opening noted mid-incision.The right groin is healed.No erythema, no peri wound edema, no skin maceration, non-tender, no induration.¿ on 11/26/2019, the site confirmed ¿the patient is doing well¿.The clinic assessment on (b)(6) 2019 stated: ¿small area of incision unhealed with serous drainage, possibly post-surgical edema vs.Lymph leak.¿ a lower extremity arterial duplex exam described the area as: ¿irregular hypoechoic, non-vascularized collection in the right groin measuring 1.39cm x 1.18cm x 1.21cm.Suggestive of a hematoma.¿ the patient is an 80-year-old female with pertinent medical history including: rutherford category 3 peripheral artery disease (pad), hypertension (controlled with single drugs), and nyha class i congestive heart failure.Additional information, including surgical notes, are not available for consideration in this complaint evaluation.It is unknown whether the patient had drainage tubes in place to decrease the risk of fluid buildup.The event was classified as an adverse event that was related to the vascular surgery and possibly related to photofix.The surgeon stated: ¿this patient has what appears to be a lymphocele in the early postoperative period.She had a recently placed patch and the lymphocele is either related to the surgery itself or the patch used.It is impossible for me to conclude that this is unrelated.¿ conclusion: the source of the patient¿s lymphocele is unknown.Lymphatic complications following vascular procedures, such as feas, are anticipated and described in the literature.Risk factors for lymphatic complications included 80 years of age.Information on post-operative care, such as the use of surgical drains, cannot be considered in this report.Based on the available information, there is no evidence to suggest that the lymphocele is associated with photofix.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.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 - 2CM X 9CM
• 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: 9401998
• MDR Text Key: 168889001
• Report Number: 1063481-2019-00074
• 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: study
• Type of Report: Initial,Followup
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 03/18/2021
• Device Model Number: PFP2X9
• Device Lot Number: 61032019
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/08/2019
• Date Manufacturer Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 83