MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X ASCENDING AORTIC PROSTHESIS WITH THE VASCUTEK GELWEAVE VALSALVA GRAFT; HEART VALVE, MECHANICAL

Model Number ONXAAP-23

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Stroke/CVA (1770); Embolism (1829)

Event Date 03/08/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient was initially presented to the hospital on (b)(6) 2019 with stroke-like symptoms of numbness in the v3 region on the right side of his face and weakness and numbness in his right hand.His inr target was 1.5-2.5.Upon admission he started on heparin protocol and his inr was increased to a new target of 2-3.He was discharged, symptom-free on the (b)(6) 2019, but as he was having lunch he developed symptoms again, presented back to the hospital, and had a repeat ct scan which showed a small, left frontal subacute infarct with no hemorrhagic transformation.He was restarted on heparin protocol following ct and continued on his warfarin.He was kept in the hospital until his inr was greater than 2.At time of discharge, his inr was 2.5.His symptoms resolved and on exam in the morning of (b)(6) 2019 he had some mild numbness in the v3 distribution on the right side of his face, but was otherwise neurologically intact.His blood pressure was elevated with a systolic reading in the 140s and his medication was increased from 2.5mg twice a day to 5mg twice a day.He was discharged in stable condition.

Event Description

Patient was initially presented to the hospital on march 8, 2019 with stroke-like symptoms of numbness in the v3 region on the right side of his face and weakness and numbness in his right hand.His inr target was 1.5-2.5.Upon admission he started on heparin protocol and his inr was increased to a new target of 2-3.He was discharged, symptom-free on the (b)(6) 2019, , but as he was having lunch he developed symptoms again, presented back to the hospital, and had a repeat ct scan which showed a small, left frontal subacute infarct with no hemorrhagic transformation.He was restarted on heparin protocol following ct and continued on his warfarin.He was kept in the hospital until his inr was greater than 2.At time of discharge, his inr was 2.5.His symptoms resolved and on exam in the morning of (b)(6) 2019, he had some mild numbness in the v3 distribution on the right side of his face, but was otherwise neurologically intact.His blood pressure was elevated with a systolic reading in the 140s and his medication was increased from 2.5mg twice a day to 5mg twice a day.He was discharged in stable condition.

Manufacturer Narrative

Corrected data: b3- date of event corrected to (b)(6) 2019.B6- relevant tests/laboratory data, including dates updated to (b)(6) 2019.- ct of head; white blood cells 6.8; hemoglobin 140; mcv 88; platelet count 201; (b)(6) 2019.Inr 1.9; (b)(6) 2019.- echocardiogram.B7- other relevant history,updated to history of congestive heart failure; concomitant.Surgery- aortic arch aneurysm.D1- brand name corrected to on-x ascending aortic prosthesis with the vascutek.Gelweave valsalva graft.D4- model number corrected to onxaap-23.D4- expiration date updated to 08/01/2021.D4- udi # updated to (b)(4).D6- implant date corrected to (b)(6) 2018.D11- concomitant medical products updated to atorvastatin, ramipril, bisoprolol.Trial adjudicator reviewed the case and stated: ¿this patient presents twice with cva symptoms, (b)(6) which was documented by a ct after an initial study was not definitive.There is no clear report indicating this is not related to an embolic event.The valve study (echo) did not show any indication of a valvular thrombus, but the nature of the cva would imply that this was an embolic event.There is no neurologic report to indicate otherwise and the indication is that this was a small infarct, most consistent with an embolus and not of vascular origin.I would have to consider this to be a valve-related event.¿ the manufacturing records 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.A review of the available information was performed.Onxaap-23 sn (b)(4) was implanted in the aortic position of a 72-year-old male patient on (b)(6) 2018.On (b)(6) 2019 (135 days post implant) patient exhibited symptoms of neurologic ischemic stroke but fully recovered in 4 days after the short-term addition of heparin.Anticoagulation inr at the time of the event is reported as 2.1.A ct of the head without contrast on (b)(6) 2019 concluded ¿mild subcortical decreased attenuation in the posterior left frontal lobe which could be mild small vessel ischemic disease or a small subcortical infarct¿no hemorrhage or hydrocephalus.¿ an echocardiogram on (b)(6) 2019 stated ¿no definite cardiac source of thromboembolism is identified.¿ the valve appeared to be functioning normally and no thrombus could be seen.Symptoms recurred on the fourth day, but patient was again placed on heparin and warfarin increased until greater than 2.0 before hospital discharge on (b)(6) 2019 (at which time it was 2.5).Diagnosis was thromboembolic induced stroke.The origin of the thromboembolism could not be established, but an adjudication committee member said the symptoms were consistent with an embolus, not of vascular origin.Consequently, a valve-related origin could not be ruled out, although neither was it definitive.In the instructions for use for the on-x model ascending aortic prosthesis (onxaap) the recommended ¿anticoagulation/anticoagulation regimen is based on the particular needs of the patient, the clinical situation and established professional guidelines.¿ [ifu-aap].The onxaap did not receive an explicit inr 1.5-2.0 approval from the fda.Thromboembolism is a known potential complication of prosthetic valve replacement [ifu-aap] occurring at a historical rate of 3.0 % per patient-year for rigid heart valves [iso 5840:2005e].This is a case of stroke-like symptoms attributed to a possible valve-related thromboembolism.But this is not definitively established and we therefore, have no clear evidence what, if any, contribution the valve had to its occurrence.No further action is required.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 ASCENDING AORTIC PROSTHESIS WITH THE VASCUTEK GELWEAVE VALSALVA GRAFT
• 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: 8568385
• MDR Text Key: 143669535
• Report Number: 1649833-2019-00028
• 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: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 08/01/2021
• Device Model Number: ONXAAP-23
• Device Catalogue Number: ONXAAP-23
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/26/2019
• Date Manufacturer Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 72 YR