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

Model Number ON-X PROSTHETIC HEART VALVE

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

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

Event Type  Injury  

Manufacturer Narrative

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

Event Description

To anticoagulate or not? that is the question.Management of high-risk patients with mechanical mitral and double valves: a case series "his postoperative course was routine and he and was discharged on coumadin with a goal inr of 2.5-3.5, using the higher inr recommendation for an on-x mitral valve.Within 24 hours of discharge, the patient was brought into the emergency room with symptoms of left-sided paresis and dysarthria.A ct scan of the head revealed a large intracranial bleed with midline shift, in the face of a 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 only mild short-term memory loss and mild word finding capability but with full return of strength and speech.His postoperative echocardiogram three months later revealed no evidence of thrombosis on either valve leaflets, despite a sub therapeutic inr in the range of 1.5-2." the patient has a history of mitral valve prolapse that was surgically repaired with a p2 leaflet excision and annuloplasty ring.Pathology of the mitral leaflet showed positive for loeys-dietz syndrome.The patient was closely monitored with serial echocardiograms, and was found to have progressive dilatation of his aortic root and return of mr a little over 1 year post op.A little more than 1 year after the mitral valve repair, the patient underwent a redo sternotomy for double valve replacement.An aortic root replacement with an on-x valve and conduit was placed in the aortic position and a mitral valve replacement with an on-x mitral valve were completed.

Manufacturer Narrative

This is a journal article review of two case studies discussing the applicability of anticoagulation guidelines [joseph 2019].The first case study concerns a non-on-x valve and will not be reviewed here.The second case study concerns a 38-year-old male patient diagnosed with loeys-dietz syndrome who received an on-x ascending aortic prosthesis (onxaap) and an on-x mitral valve (sizes and serial numbers not given), i.E.A double valve case.The on-x patient was initially placed on an inr target range of 2.5-3.5 based upon the current guidelines for mechanical mitral valves [nishimura 2017].However, within 24 hours post-surgery, with an inr measured at 2.0, the patient experienced left-sided paresis and dyarthria.A ct scan of the head revealed a large intracranial bleed with midline shift.After medical treatment, including heparin bridging to inr 1.5-2.0, the patient recovered with only mild short-term memory loss and mild word finding capability but with full return of strength and speech.He was assigned an inr target of 1.5-2.0 and an echocardiogram three months later revealed no evidence of valve thrombosis.The author then discusses the merits of the published anticoagulation guidelines for mechanical valves and attempts to make the case that perhaps the guidelines do not adequately take into account the hemodynamic advantages, at least theoretically, of the on-x design, which seems to tolerate lower inr ranges than the current guidelines recommend.The author advocates more clinical outcome data to help evaluate the appropriate levels of anticoagulation, particularly for the valves with an apparent history of requiring less of it.He also suggests exploration of novel oral anticoagulation alternatives.The article reports a case of bleeding for a recipient of the on-x aap and on-x mitral valve despite a lower inr.Historically for rigid prosthetic valves in either position, the rate of all hemorrhage is listed at 3.5%/patient-year [iso 584:2005].The inferred cause of bleeding for a double on-x valve recipient is over-anticoagulation.The author makes the case that the on-x valve may require less anticoagulation than that recommended by the current guidelines.No further action is required.The journal publication discusses a case of a double on-x valve recipient that is over-anticoagulated.The complications associated with over-anticoagulation, referenced in the publication, are listed in the ifu.It provides instruction about the potential adverse events associated with the use of prosthetic heart valves which may lead to explantation, reoperation or death.The risk management file thoroughly identifies the process and product hazards for approved indications.Each individual hazard is mitigated and reduced as low as possible by design and process.Post production residual risk is communicated in the product¿s labeling and ifu.No action necessary.This event does not identify additional hazards or modify the probability and severity of existing hazards.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.

• Brand Name: ON-X PROSTHETIC HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): CRYOLIFE, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 9115677
• MDR Text Key: 165465451
• Report Number: 1649833-2019-00060
• 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,litera
• Type of Report: Initial,Followup
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ON-X PROSTHETIC HEART VALVE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/19/2019
• Initial Date FDA Received: 09/25/2019
• Supplement Dates Manufacturer Received: 09/19/2019
• Supplement Dates FDA Received: 10/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 38 YR