MAUDE Adverse Event Report: CRYOLIFE, INC. ONX AORTIC CONFORM EXT 23; HEART-VALVE, MECHANICAL

Model Number ONXACE-23

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

Patient Problem Blood Loss (2597)

Event Date 02/08/2018

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 an email received on (b)(6) 2018: "patient has experienced a complication which was registered in the database on (b)(6) 2018.The complication entered is bleeding event.".

Event Description

According to an email received on 07/05/2018: "patient has experienced a complication which was registered in the database on (b)(6) 2018.The complication entered is a bleeding event.".

Manufacturer Narrative

The manufacturing records for the product were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.All lots passed functional testing and met release specifications.During the investigation no non-conformances or deviations were noted.The product passed multiple tests/inspections in order to meet specifications prior to release.No change orders or non-conformances are noted with the processing of the valve.A 44 year old male patient implanted with the valve on (b)(6) 2017 with concomitant cabg (4 grafts).Patient has a history of congestive heart failure, vascular pathology (unknown), diabetes mellitus, hypertension, and hypercholesterolemia.Patient experienced bleeding event, retinal bleed blindness with permanent impairment on (b)(6) 2018.Inr was 2.8 (close to the upper limit 3.0) at the time of event on warfarin and asa per protocol.Site indicated on crf that event was not related to device.Patient also experienced on (b)(6) 2018 and was hospitalized for ulceration of leg around vein craft harvest site (indicated as not related to device).Maintaining the proper balance of anticoagulant is critical.Although not within the fda approved, lowered targeted inr range of 1.5-2.0, patient inr on two separate dates fall within the general guideline of 2.0-3.0.Bleeding is a recognized potential complication for mechanical valve recipients [instructions for use].The objective performance criteria lists a rate of major hemorrhage for rigid valve recipient of 1.5%/pt-year.Although inr is higher than the protocol range of 1.5-2.0, it is still within acceptable limits.A definitive root cause for the reported event is unknown.As indicated in the crf's, the event is non product related and there is no information indicating otherwise.This report is being submitted as required by regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, the 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.

• Brand Name: ONX AORTIC CONFORM EXT 23
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): CRYOLIFE, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 7742228
• MDR Text Key: 115792945
• Report Number: 1649833-2018-00135
• 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: study
• Type of Report: Initial,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2023
• Device Model Number: ONXACE-23
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/05/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 44 YR