MAUDE Adverse Event Report: EDWARDS LIFESCIENCES ALTERRA ADAPTIVE PRESTENT SYSTEM; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

Model Number 29AP4045CLUS

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

From alterra study, post operative day (pod) 1462, a prestent fracture (1 wire fractures, type i) was observed by principal investigator (pi) when assessing the x-ray.The patient status and treatment remains unknown at this time.

Manufacturer Narrative

The investigation is ongoing.The device remains implanted.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information.The following sections of this report have been updated: corrected h.6 investigation conclusions.Added new information to h.6 type of investigation and investigation findings.Per core labs analysis of the image, the image did not result in the identification of a prestent fracture.Based on these results, this complaint is no longer considered to be a complaint and/or reportable event.

• Brand Name: ALTERRA ADAPTIVE PRESTENT SYSTEM
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 14117973
• MDR Text Key: 291390958
• Report Number: 2015691-2022-05096
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/01/2022

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 Model Number: 29AP4045CLUS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/18/2022
• Initial Date FDA Received: 04/15/2022
• Supplement Dates Manufacturer Received: 05/26/2022
• Supplement Dates FDA Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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