MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS; TISSUE, HEART-VALVE

Model Number 11500A

Device Problems Improper or Incorrect Procedure or Method (2017); Tear, Rip or Hole in Device Packaging (2385); Packaging Problem (3007)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/24/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: customer report of final packaging of a valve found damaged was confirmed through visual observation.As received, the valve shelf box was returned with a broken tamper seal, the outer packaging tray lid valve packaging was fully detached from seal and had wrinkled labeling, and the inner packaging tray with valve remained sealed.The adhesive appeared to be transferred from lid to tray with no visible breaks around the tray.Perforated damage was observed on one corner edge of the inner tyvek lid and tray.No visible inconsistencies were observed on the returned valve.Photos provided appeared consistent with lab findings.Additional manufacturer narrative: the device was returned for evaluation.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.A definitive root cause cannot be determined at this time.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

Edwards received notification that the final packaging of this valve was found damaged.As reported, the inner tray was torn and this resulted in a breach of the sterile barrier.The outer packaging was in good condition.It was alleged that the issue was found that way inside the packaging.The nurse opened the outer tray manually, without using a tool.There was no consequences for the patient since the issue was observed before use.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10070969
• MDR Text Key: 194642736
• Report Number: 2015691-2020-11899
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2020
• Device Model Number: 11500A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1