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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 11/18/2018

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to initial reports, patient experienced a bleeding event (b)(6) 2018 and lasted until (b)(6) 2018.Original surgery date was (b)(6) 2018.Patient was hospitalized.The anticoagulation therapy is warfarin.Cardiac rhythm ¿ sinus, disease etiology ¿ calcific, aortic valvular lesions ¿ stenosis, no previous cardiac surgery.Date of surgery: (b)(6) 2018.Suture technique ¿ continuous, cross-clamp time ¿ 59 minutes, cardioplegia temperature ¿ cold alone, infusion mode ¿ antegrade alone, intra-operative heparin.Current anticoagulant therapy ¿ warfarin.Inr ¿ 2.4 as of (b)(6) 2019.Complication: event start date (b)(6) 2018, event ongoing no, event end date (b)(6) 2018, event duration in days 12.This event: bleeding event ¿ mesenteric bleed.Outcome of event: unknown.Treatment: hospitalization.Cardiac rhythm at event: unknown.Nyha functional class: unknown.Anticoagulant therapy: warfarin.Event related to device: no information.

Event Description

According to initial reports, patient experienced a bleeding event (b)(6) 2018 and lasted until (b)(6) 2018.Additional information received confirmed the bleeding event was a duodenal hematoma unrelated to the on-x valve.

Manufacturer Narrative

Additional information received confirmed the bleeding event was a duodenal hematoma and unrelated to the on-x implant.Based on this information an investigation will not be initiated as the event is unrelated to the mechanical heart valve.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.

• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson lane, bldg. b; austin TX 78752
• MDR Report Key: 8444123
• MDR Text Key: 139585240
• Report Number: 1649833-2019-00018
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/19/2019
• Date Manufacturer Received: 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 61 YR