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

Model Number ONXAE

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 10/21/2013

Event Type  No Answer Provided  

Manufacturer Narrative

The valve remains implanted and functioning normally.The valve was not explanted so no serious injury.Peripheral thromboembolism detected which was corrected medicinally, using thrombectomy.Review of factory device history records shows the device was built per specifications.

Event Description

Event occurred in (b)(6).Peripheral thromboembolism, post-operative-early.Pt complained of sudden pain in right lower limb on (b)(6).Emergency thrombectomy was performed.Echo did not reveal apparent thrombosed valve, no intracardiac thrombus was observed.Holter ekg detected frequent pac's (premature atrial contractions).Inr on date of event was subtherapeutic at 1.45.Heart valve remains implanted and functioning normally.This event falls within the definitions in the aats/sts guidelines as a valve-related event and is therefore reportable.It is an expected adverse event, as defined in the objective performance criteria in fda heart valve guidance, and iso 5840, and this occurrence is within expected rate.No trend is seen.On (b)(6) 2015, onxlti received a set of data from the sponsor of a (b)(6) post-market study, where-in they wanted on-x to do data analysis on a set of data containing adverse events.The valve on this mdr is one of the ae's.Once analyzed against the entire population in the (b)(6) study (only avr has enough data for proper analysis) and then comparing to the pma.You get the following results.Event: thromboembolism, (b)(6) study (%/ptyr): 0.71, pma study (%/ptyr): 1.7.Thrombosis, 0.00, 0.00.Endocarditis, 0.61, 0.5.Paravalvular leak, 0.40, 0.7.Bleeding, 1.21, 0.7.Pannus, 0.00, 0.00.Composite te and bleed, 1.92, 2.4.Sudden death, 0.20, 0.20.There are no statistically significant differences in these rates and this trial was run at inr of 1.5 to 2.5 versus the pma at 2.0 to 3.0.At lower inr low rates are expected based on our research.So these events while mdr reportable as individual occurrences, they are overall in the range expected.

• Brand Name: ON-X AORTIC PROSTHETIC HEART VALVE
• Type of Device: MECHANICAL HEART VALVE
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln, bldg b; austin TX 78752
• Manufacturer Contact: walt moeller, director ; 1300 e. anderson ln, bldg b; austin, TX 78752 ; 5123398000
• MDR Report Key: 5000656
• MDR Text Key: 23424111
• Report Number: 1649833-2015-00013
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001419
• UDI-Public: 00851788001419
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,study
• Reporter Occupation: Not Applicable
• Report Date: 08/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/20/2017
• Device Model Number: ONXAE
• Device Catalogue Number: ONXAE-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 55 YR