MAUDE Adverse Event Report: EDWARDS LIFESCIENCES ENDOVENT; REPLACEMENT HEART VALVE

Model Number EV

Device Problem Shipping Damage or Problem (1570)

Patient Problem No Information (3190)

Event Date 09/20/2017

Event Type  malfunction  

Manufacturer Narrative

There have been reports of products that were received in a crushed shipping box.This may result in crushed product boxes and/ or damaged or kinked devices.If damaged, the products will not be usable.There is no allegation of product malfunction.In this case, the damage compromised the integrity of the sterile barrier.Based on the available information, the root cause remains indeterminable.However it is likely that the damage occurred during shipping and handling.A device history record review in in progress and a supplemental report will be submitted upon completion.

Event Description

Edwards received information that this pulmonary vent catheter was received by the customer with a damaged box and the product was damaged as well.No additional details were provided.

Manufacturer Narrative

Additional manufacturer narrative: 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: ENDOVENT
• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; 1 edwards way; mle-2; irvine, CA 92614 ; 9492502289
• MDR Report Key: 6966972
• MDR Text Key: 90687880
• Report Number: 3008500478-2017-00048
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K981009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2018
• Device Model Number: EV
• Device Catalogue Number: EV
• Device Lot Number: 61009020
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2017
• Initial Date FDA Received: 10/20/2017
• Supplement Dates Manufacturer Received: 11/28/2017
• Supplement Dates FDA Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2017
• 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