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

Model Number ONXM UNK

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

Patient Problems Intracranial Hemorrhage (1891); Paresis (1998); Thromboembolism (2654)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

We present the case of a (b)(6) male who initially presented with what appeared to be isolated mitral valve prolapse with severe mitral regurgitation (mr) from flail p2 leaflet.His ejection fraction (ef) at the time was 25% with mild aortic insufficiency (ai).He underwent a mitral valve repair with a p2 leaflet excision and annuloplasty ring with excellent postoperative results.His pathology however, came back positive for loeys-dietz based off of the mitral leaflet.Subsequent genetic testing and was found to positive for an acquired variant of loeys-dietz.He was closely monitored clinically with serial echocardiograms and was found to have progressive dilation of his aortic root and return of his mr, a little over a year from his surgery.His aortic root measured 5cm with mild ai; however his ef had dramatically improved to normal despite the return of his mr.He subsequently underwent a redo sternotomy with a double valve replacement a little over a year after his mitral valve repair.Specifically, he underwent a root replacement with an on-x valve conduit in his aortic position and mitral valve replacement (mvr) with a on-x as well.His postoperative course was routine and he and was discharged on coumadin with a goal inr of 2.5-3.5, choosing the higher inr recommendation for an on-x mitral valve.Within 24hrs of discharge, the patient was brought into the emergency room with stroke like symptoms of left sided paresis and dysarthria.Ct scan of the head revealed a large intracranial bleed with midline shift in the face of sub therapeutic inr of 2.He was emergently taken for decompressive craniectomy with reversal of his anticoagulation.Postoperatively his anticoagulation was re-initiated with heparin once it was determined to be safe from a neurosurgical standpoint.He was eventually bridged to coumadin with an inr kept on the lower end of a 1.5-2 range, given his intracranial hemorrhage.He had significant recovery with mild short-term memory loss and mild word finding capability but had full return of strength and return of speech.Postoperative echo 3 months later revealed no evidence of thrombosis on either valve leaflets with good function, despite keeping him on a sub therapeutic inr range of 1.5-2.This case will be relegated to the mitral valve.All attempts at correspondence have gone unmet.This investigation is relegated to the mitral valve.

Event Description

According to the paper, case of a (b)(6) year old male who initially presented with what appeared to be isolated mitral valve prolapse with severe mitral regurgitation (mr) from flail p2 leaflet.His ejection fraction (ef) at the time was 25% with mild aortic insufficiency (ai).He underwent a mitral valve repair with a p2 leaflet excision and annuloplasty ring with excellent postoperative results.His pathology however, came back positive for loeys-dietz based off of the mitral leaflet.Subsequent genetic testing and was found to positive for an acquired variant of loeys-dietz.He was closely monitored clinically with serial echocardiograms and was found to have progressive dilation of his aortic root and return of his mr, a little over a year from his surgery.His aortic root measured 5cm with mild ai; however his ef had dramatically improved to normal despite the return of his mr.He subsequently underwent a redo sternotomy with a double valve replacement a little over a year after his mitral valve repair.Specifically, he underwent a root replacement with an on-x valve conduit in his aortic position and mitral valve replacement (mvr) with a on-x as well.His postoperative course was routine and he and was discharged on coumadin with a goal inr of 2.5-3.5, choosing the higher inr recommendation for an on-x mitral valve.Within 24hrs of discharge, the patient was brought into the emergency room with stroke like symptoms of left sided paresis and dysarthria.Ct scan of the head revealed a large intracranial bleed with midline shift in the face of sub therapeutic inr of 2.He was emergently taken for decompressive crainectomy with reversal of his anticoagulation.Postoperatively his anticoagulation was re-initiated with heparin once it was determined to be safe from a neurosurgical standpoint.He was eventually bridged to coumadin with an inr kept on the lower end of a 1.5-2 range, given his intracranial hemorrhage.He had significant recovery with mild short-term memory loss and mild word finding capability but had full return of strength and return of speech.Postoperative echo 3 months later revealed no evidence of thrombosis on either valve leaflets with good function, despite keeping him on a sub therapeutic inr range of 1.5-2.This case will be relegated to the mitral valve.All attempts at correspondence have gone unmet.This investigation is relegated to the mitral valve.

Manufacturer Narrative

A review of the available information was performed.An unpublished manuscript authored by (b)(6), md describes a case study of anticoagulation consideration for a patient receiving an on-x ascending aortic prosthesis (onxaap) and a mitral on-x valve (onxm) in a double-valve avr/mvr case.Neither valve was identified or verified by serial number.The patient is described as a (b)(6) year old male later diagnosed with an acquired variant of loeys-dietz.A year after a mitral valve repair, the patient had the avr/mvr procedure but experienced stroke-like symptoms of left-sided paresis and dysarthria within 24 hours of discharge despite sub-therapeutic inr initially targeted for 2.5 - 3.5.Ct scan revealed a large intracranial bleed with a midline shift.After emergency decompressive craniectomy and bridging with heparin, the patient was gradually returned to warfarin therapy with a lower inr target of 1.5 - 2.0.The patient made significant recovery and a 3-month postop echocardiogram showed no thrombosis on either valve despite the lower inr therapy.Recommended anticoagulation for the onxm or multiple valve positions follows the guidance of the aha and acc, i.E.An inr target of 2.5 - 3.5.[instructions for use, nishimura et.Al 2014) the original inr therapy was based upon this recommendation, but the intracranial bleed caused a reassessment resulting in the lower inr recommendation.This is an appropriate adjustment to the particular needs and clinical condition of the patient, who, in this case, may have been especially susceptible to bleeding due to his loeys-dietz.There is no indication or suggestion that the complication experienced by the patient is in any way related to the presence of the onxm other than the fact that all mechanical valve recipients are recommended anticoagulant therapy of warfarin and aspirin unless medically contraindicated.Root cause for this event is unusual physiology requiring specialized anticoagulation therapy tailored to the patient's particular needs.No further action is warranted at this time.

• Brand Name: ON-X MITRAL VALVE UNKNOWN CONFIGURATION
• Type of Device: HEART VALVE MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 6952357
• MDR Text Key: 89488763
• Report Number: 1649833-2017-00076
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: ONXM UNK
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/18/2017
• Date Manufacturer Received: 09/18/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 38 YR