MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X PROSTHETIC HEART VALVE; MECHANICAL HEART VALVE

Model Number ONXACE

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Interim evaluation made based on photos provided by distributor.Still awaiting return of device.Currently being reported as malfunction, although in 100% of investigations of this condition in past occurrences has been that this is not a malfunction, but is a user error.After investigation, a follow-up report will be filed with the final conclusion.Device not yet received.

Event Description

Distributor in (b)(4) notified onxlti that the sewing ring stitching was unravelling.The condition was noticed at the beginning of the surgery.The valve will be returned to onxlti for investigation.Any past occurrences of this type have been attributed to iatrogenic damage, where the surgeon's needle path was too close to the valve body where the sewing ring construction suture is located, cutting the construction suture, and allowing it to unravel as far as 4 stitches up to the point of the stop knot.Unravelling does not progress beyond the stop knot.The conclusion of the past cases is that the valve did not malfunction, it was damaged by user error.(the ifu is clear on instructions about needle path in the sewing ring).This is the expected conclusion of the investigation for the valve in this mdr, however, the valve has not yet arrived.Therefore this is being reported.Once investigation is complete, a follow-up mdr will be filed stating the findings.

• Brand Name: ON-X PROSTHETIC HEART VALVE
• Type of Device: MECHANICAL HEART VALVE
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln; building b; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson lane; building b; austin TX 78752
• Manufacturer Contact: walt moeller ; 1300 e. anderson ln; building b; austin, TX 78752 ; 5123398000
• MDR Report Key: 5157705
• MDR Text Key: 28851991
• Report Number: 1649833-2015-70025
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/11/2019
• Device Model Number: ONXACE
• Device Catalogue Number: ONXACE-21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2014
• 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