MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INTUITY ELITE VALVE SYSTEM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 8300DB

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 11/17/2020

Event Type  malfunction  

Manufacturer Narrative

Device code = expired product.The device was not returned to edwards for evaluation.Attempts to retrieve the device and additional information is in process.If additional information is received a supplemental mdr will be submitted.Use of expired product.Occasionally we become aware of an implant with an already expired product.This is typically a result of use error and does not represent a malfunction of the product.In this case it was reported it was an accident hospital used expired product.The definitive cause cannot be determined at this time.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.

Event Description

Edwards received information an expired delivery system kit was used to implant the 27mm aortic valve that was not expired.Procedure went successfully.No concern from the patient.

Event Description

The patient also underwent coronary artery bypass grafting x 5 during the procedure.The patient was transferred to the icu in critical, but stable condition.Patient was discharged on post-operative day seven (7).

Manufacturer Narrative

H3.Device evaluation: customer report of expired 8300kitb27a was confirmed.Attached deco paperwork appears to have a photocopy of returned kit shelf box label (see 2020-10126-1.Pdf page 3).Returned kit shelf box label lists a use-by date of 2020-11-12.Only a delivery system was received in the product evaluation lab.Valve and other kit components were not returned.Delivery system was returned with valve holder and balloon introducer still attached.As received, the delivery system was in the deployed position with locking sleeve engaged.No visible inconsistencies were observed on the returned delivery system.H10.Additional manufacturer narrative: d4.Udi number: (b)(4).The complaint was confirmed.H11.Corrected data: corrected d1, d4, h4.The device history record (dhr) was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.Based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 10952998
• MDR Text Key: 220981846
• Report Number: 2015691-2020-14872
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2020
• Device Model Number: 8300DB
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR