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

Model Number	ONXACE
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
As per the request submitted by fda medwatch program, this report is being resubmitted as report number 1649833-2016-70004-1.This report previously was submitted as 1649833-2015-70025-1, february 9, 2016.Description from original follow-up medwatch report as follows: this is a follow-up report to the original mdr no.1649833-2015-70025-1.Event occurred in (b)(6).Original report stated: "distributor in b)(4) notified onxlti that the sewing ring stitching was unraveling.The condition was noticed at the beginning of the surgery.The valve will be returned to onxlti for investigation".The valve has been returned and evaluated.This valve is very similar to past occurrences of this type which 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 a the stop knot.Unraveling does not progress beyond the stop knot, it is concluded 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.

• Brand Name: ON-X PROSTHETIC HEART VALVES
• Common Device Name: MECHANICAL HEART VALVE, PRODUCT CODE: DYE
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln; bldg b; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1300 e. anderson ln; bldg b; austin, TX 78752 ; 7704193355
• MDR Report Key: 5420058
• Report Number: 1649833-2016-70004
• Device Sequence Number: 3659575
• Product Code: DYE
• UDI-Device Identifier: 00851788001457
• UDI-Public: 00851788001457
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

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 Expiration Date: 12/11/2019
• Device Model Number: ONXACE
• Device Catalogue Number: ONXACE-21
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2015
• Supplement Date Received by Manufacturer: 09/09/2015
• Initial Report FDA Received Date: 02/09/2016
• Supplement Report FDA Received Date: 02/09/2016
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown