MAUDE Adverse Event Report: ST. JUDE AERIS FFR WIRE

Model Number C12358

Device Problem Defective Component (2292)

Patient Problem Death (1802)

Event Date 12/29/2013

Event Type  Death  

Event Description

St.Jude ffr wire was stuck in lm/aorta and could not be removed with snare devices or other means (wire looped).The ffr wire broke off and was unable to be retrieved by multiple physicians.

• Brand Name: AERIS FFR WIRE
• Type of Device: AERIS FFR WIRE
• Manufacturer (Section D): ST. JUDE; austin TX
• MDR Report Key: 3750413
• MDR Text Key: 4465301
• Report Number: 3750413
• Device Sequence Number: 1
• Product Code: DXO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2014,02/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Model Number: C12358
• Device Lot Number: 133966
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/28/2014
• Distributor Facility Aware Date: 02/13/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/20/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 85 YR
• Patient Weight: 48