MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS PERICARDIAL PATCH; REPLACEMENT HEART VALVE

Model Number 4700

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 09/13/2017

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: customer report of hair-like material was found on patch was confirmed.One brown fiber that measured approximately 19mm was found on the patch.The patch was rinsed three times using saline solution per ifu.The fiber remained attached to the patch post clinical rinse.The fiber will be sent to chemistry for analysis.Additional manufacturer narrative: it is standard of care and prescribed in the ifu that valves and patches undergo a series of extensive rinses during the preparation phase prior to implant in the patient.This rinse process is required as the valves and patches are stored in glutaraldehyde.Accessories are also typically rinsed prior to use.It is possible, during this standard / mandatory device preparation, fibers or particulate may be observed.There are inherent tissue fibers on the ¿rough¿ surface of the pericardial tissue that at times can be difficult to distinguish from particulate.The rinse process should remove all particulate.As a result, small amounts of particulate are highly unlikely to enter the patient and cause injury.There are cases, however, where the particulate can be partially embedded in or attached to the leaflet or valve.If the particulate can be rinsed, the potential for injury to the patient is remote.If the particulate could be not removed during the rinsing process, and the valve was used in a patient, there is a potential for the particulate to enter the patient and embolize.Events of particulate remaining on the device after the preparatory rinse will be reportable.In this case, a hair-like material was observed to be on the patch prior to use.The root cause of the event remains indeterminable at this time.A supplemental report will be submitted to include the chemistry results and device history record review upon completion.

Event Description

Edwards received information that a hair-like material was found on this pericardial patch by a nurse before use.This patch was going to be used for an emergent surgery for an infective endocarditis patient.The first nurse opened the jar and took the patch out of the jar.The second nurse found a hair-like material on the patch.This patch was not used and there was no contact to a patient.The customer would like to know if this particle was a human hair or non-human hair, and if it was originally in the jar or it was contaminated at the hospital.Device was returned for evaluation.

Manufacturer Narrative

Though further investigation, it is possible that the hair particulate came from the hospital staff.As reported, the first nurse opened the jar and took out the patch, and the second nurse found that the patch had a hair on it.However, a definitive source of the hair could not be conclusively determined.This is not a confirmed manufacturing defect.To be conservative, operator awareness training was performed.No further corrective actions have been deemed necessary.Edwards will continue to review of all reported events and perform trend analysis on a monthly basis.If action is required based, appropriate investigation will be performed.

Manufacturer Narrative

Supplemental submitted to include dhr review and chemistry analysis.The ir spectrum of the unknown brown fiber showed similar absorption characteristics when comparing to protein like material.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

• Brand Name: EDWARDS PERICARDIAL PATCH
• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; 1 edwards way; m/s mle 2; irvine, CA 92614 ; 9492502289
• MDR Report Key: 6919173
• MDR Text Key: 89467573
• Report Number: 2015691-2017-03246
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K833763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2021
• Device Model Number: 4700
• Device Catalogue Number: 4700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1