MAUDE Adverse Event Report: EDWARDS LIFESCIENCES KONECT RESILIA AORTIC VALVED CONDUIT AVC; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 11060A29

Device Problems Contamination /Decontamination Problem (2895); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2023

Event Type  Injury  

Manufacturer Narrative

H10: additional manufacturer narrative: the investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

It was reported that during the implant procedure of an 11060a konect aortic valved conduit a small plastic, pericardial-like specimen was found on one of the leaflets.The surgeon stated that it was sitting on the belly of one of the cusps.This particle was not attached but sitting on the cusp, so the surgeon removed it.The specimen was removed with forceps and put in a specimen cup.This specimen was noticed after the sutures were in the cuff and the surgeon did not want to have to re-suture the annulus, so the konect valve remained implanted.The patient did well post procedure and was discharged home.It was noted that the 11060a konect valved conduit was soaked prior to implantation.

Manufacturer Narrative

The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.H3: evaluation summary: customer report of particulate was confirmed.An unknown particulate approximately 4mm long was returned.Device was not returned with particulate.Particulate was sent to chemistry for analysis.The sample spectrum is consistent with that of polyisoprene.

Manufacturer Narrative

Customer complaint of particulate confirmed through evaluation of returned particulate.The specific allegation that the particulate was identified on the leaflet of the device is unable to be confirmed based on the information provided; however, the complaint is conservatively confirmed.There is no confirmed edwards or supplier manufacturing defect.Per product evaluation, the customer's report of particulate was confirmed.An unknown particulate approximately 4mm long was returned.Device was not returned with particulate.Ftir analysis of the particulate determined that the particulate material is consistent with polyisoprene.Of note, polyisoprene is a commonly used as a material in the manufacture of surgical gloves.A dhr review was performed, and no related manufacturing nonconformances were identified.As per current manufacturing process controls, 100% particulate inspection is performed on the valve inflow and outflow prior to holder attachment, 100% particulate inspection is performed on the valve inflow and outflow & holder after holder attachment, 100% particulate inspection is performed on the valve inflow and graft after inner stitch of valve attachment, and 100% particulate inspection is performed on the valve inflow and graft after outer stitch of valve attachment.Any particulate originating from a sterile glove during resilia processing would be detected.Based on the preliminary investigation, the possibility of manufacturing process being a source of particulate cannot be completely ruled out.However, the likelihood of a 4mm particulate escaping undetected is extremely low since there are adequate process controls to mitigate any risk of particulates on the product.Therefore, manufacturing process of konect avc resilia (11060a) could not be confirmed as the root cause since sterile gloves are also used in the operating room by health care professionals.An awareness communication will be conducted as a correction to reinforce established procedure(s) and/or process(s) for 1st and 2nd shift production personnel in resilia and valve assembly areas.It is possible that the particulate originated from the operating room, however, no information regarding glove material used in the procedures was provided.Based on the investigation performed, a definitive root cause is unable to be determined.There is no confirmed edwards manufacturing nonconformance.

• Brand Name: KONECT RESILIA AORTIC VALVED CONDUIT AVC
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17986917
• MDR Text Key: 326293241
• Report Number: 2015691-2023-16990
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 11060A29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Sex: Male