MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC ON-X MITRAL HEART VALVE WITH CONFORM-X SEWING RING - 25/33; MECHANICAL HEART VALVE

Model Number ONXMC- 25/33

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 03/19/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).The on-x 614 heart valve design fmea 940816 01 rev s thoroughly identifies the process and product hazards for approved indications.Each individual hazard is mitigated and reduced as low as possible by design and process.Post production residual risk is communicated in the product's labeling and instruction for use (ifu).Reoperation is a known complication of prosthetic valve implantation and is listed in the ifu.Without return of the valve, a specific risk cannot be identified.

Event Description

Implant recovery card received indicates that patient received onxmc-25/33 on (b)(6) 2014 which required intervention/explant on (b)(6) 2014 and replacement with another onxmc-25/33 for unspecified reason.Multiple attempts to obtain additional information were made without success.

• Brand Name: ON-X MITRAL HEART VALVE WITH CONFORM-X SEWING RING - 25/33
• Type of Device: MECHANICAL HEART VALVE
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC; 1300 e. anderson ln.; bldg b; austin TX 78752
• Manufacturer (Section G): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 5995400
• MDR Text Key: 56331259
• Report Number: 1649833-2016-00033
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001303
• UDI-Public: 00851788001303
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: ONXMC- 25/33
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2016
• 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
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 70 YR