MAUDE Adverse Event Report: SORIN GROUP MITROFLOW; HEART-VALVE, NON-ALLOGRAFT TISSUE

Catalog Number LXA21

Device Problem Material Integrity Problem (2978)

Patient Problem Death (1802)

Event Date 03/10/2016

Event Type  Death  

Event Description

The patient is an elderly woman with complex medical history including non obstructive cad, htn, hyperlipidemia, mixed valvular heart disease s/p mvr/avr done five years earlier (21-mm sorin mitroflow avr and 31 biocor mvr).The 21-mm sorin mitroflow used for the avr is believed to have deteriorated prematurely.

• Brand Name: MITROFLOW
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): SORIN GROUP; 14401 west 65th way; arvada, CO 80004
• MDR Report Key: 5652290
• MDR Text Key: 45132284
• Report Number: 5652290
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• 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: 03/18/2016

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?: No
• Device Operator: No Information
• Device Catalogue Number: LXA21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/18/2016
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/18/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Outcome(s): Death
• Patient Age: 69 YR