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

Model Number ONXACE-23

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

Patient Problems Chest Pain (1776); Gangrene (1873); High Blood Pressure/ Hypertension (1908); Pneumonia (2011); Chronic Obstructive Pulmonary Disease (COPD) (2237)

Event Date 01/21/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

(b)(6) study, implanted (b)(6) 2017, event date (b)(6) 2018: presented with chest pain, sob and pyrexia.Sputum culture confirmed klebsiella pneumonia esbl+.Event date (b)(6) 2018: admitted with shortness of breath and treated as infective exacerbated copd.Event date (b)(6) 2018: presented to ed [emergency department] with vomiting, chest pain, fast heart rate and high blood pressure.Inr found to be 4.8, warfarin held.Bp controlled with amlodipine.No more chest pain.Event date (b)(6) 2018: admitted with sob.Gangrenous toes on right foot (2nd & 3rd), due to amputation of toes.Toes amputated (b)(6) 2018.Not healing well.Still in hospital (b)(6) 2018, for below knee amputation.Note from clinical trial adjudicator, dr.(b)(6), states "this patient has had a number of hospital er visits primarily for pulmonary issues secondary to copd and klebsiella pneumonia, but at no time was there a note about impaired le circulation which could be responsible for the rle gangrene and ultimate need for a bk amputation.Therefore one has to question the potential for embolization as the cause for the sudden development of gangrene in the toes and the right foot.There is a previous note that the patient had a lbbb[left bundle branch block] and therefore presumably was not in atrial fibrillation.The patient was receiving warfarin and at one time in the er, the inr was 4.8".

Event Description

On-x aortic prosthetic heart valve low dose warfarin post approval clinical registry study, implanted (b)(6) 2017, event date (b)(6) 2018: presented with chest pain, sob and pyrexia.Sputum culture confirmed klebsiella pneumonia esbl+.Event date (b)(6) 2018: admitted with shortness of breath and treated as infective exacerbated copd.Event date (b)(6) 2018: presented to ed [emergency department] with vomiting, chest pain, fast heart rate and high blood pressure.Inr found to be 4.8, warfarin held.Bp controlled with amlodipine.No more chest pain.Event date (b)(6) 2018: admitted with sob.Gangrenous toes on right foot (2nd & 3rd), due to amputation of toes.Toes amputated (b)(6) 2018.Not healing well.Still in hospital (b)(6) 2018, for below knee amputation.Note from clinical trial adjudicator, dr.(b)(6), states "this patient has had a number of hospital er visits primarily for pulmonary issues secondary to copd and klebsiella pneumonia, but at no time was there a note about impaired le circulation which could be responsible for the rle gangrene and ultimate need for a bk amputation.Therefore one has to question the potential for embolization as the cause for the sudden development of gangrene in the toes and the right foot.There is a previous note that the patient had a lbbb[left bundle branch block] and therefore presumably was not in atrial fibrillation.The patient was receiving warfarin and at one time in the er, the inr was 4.8.".

Manufacturer Narrative

A review of the available information was performed.The manufacturing records for the onxace-23 sn [serial number] 6315510 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications.All lots passed functional testing and met release specifications.Onxace-23 sn (b)(4) implanted (b)(4) 2017 in 56 year old male as part of the ¿on-x aortic prosthetic heart valve low dose warfarin post approval clinical registry study.¿ preoperatively was in sinus rhythm and nyha iii with no previous cardiac surgery; hypertensive, left atrial systolic dimensional 81mm (both are high risk factors for clotting.) patient experienced multiple events, mostly centered around shortness of breath [sob]: in (b)(4) 2018: presented to emergency department (ed) with chest pain, sob, pyrexia.Culture confirmed klebsiella pneumonia esbl+, inr [international normalized ratio] 2.3.In (b)(4) 2018: presented to ed with sob which was treated as infective exacerbated copd [chronic obstructive pulmonary disease].Inr 3.1.In (b)(4) 2018: admitted with sob.Two gangrenous toes which were amputated in (b)(4) 2018: not healing well.In (b)(4)2018: presented to ed with sob, vomiting, chest pain, tachycardia, high bp [blood pressure], inr 4.8.Inr 4.5 on (b)(4) 2018.2018 may 23 angioplasty of right infrapopliteal artery only partially successful.Patient was to recommence warfarin and low molecular weight heparin in three days, but inr was 1.2 on (b)(4) 2018.Still in hospital (b)(4) 2018 awaiting below knee amputation.Clinical adjudicator #1 for the trial states: ¿this patient has had a number of hospital er visits primarily for pulmonary issues secondary to copd and klebsiella pneumonia, but at no time was there a note about impaired le circulation which could be responsible for the rle gangrene and ultimate need for a bk amputation.Therefore one has to question the potential for embolization as the cause for sudden development of gangrene in the toes of the right foot.There is a previous note that the patient had a lbbb and therefore presumably was not in atrial fibrillation.The patient was receiving warfarin and at one time in the er, the inr was 4.8.The hospital record for the arteriogram documenting the sudden arterial occlusion would be helpful to adjudicate if this could be an embolic event or primary atherosclerotic disease.¿ following receipt of the angioplasty report he states: ¿the angioplasty report has the tp trunk diseased and the pta heavily diseased on angiogram.I would therefore believe this complication was secondary to atherosclerotic occlusion and not an embolic event.¿ adjudicator #2 states ¿agree with dx of popliteal trifurcation arteriosclerotic obstruction resulting in amputation: not valve related.However, still require hospital records to explain previous hospitalizations.¿ with additional reports, adjudicator #1 states ¿reading each of the ed discharge summaries confirms that each visit would not be valve related.At one visit the patient had a respiratory rate of 45 breaths/minute and as expected, the predominant complaint is sob.There is no indication that any of the complaints would qualify as valve-related.¿ to which adjudicator #2 states ¿agree with [adjudicator #1] hospital visits are not valve related and probably should not be listed as adverse events.¿ in summary, the patient¿s atherosclerotic disease is the underlying cause of peripheral occlusion and is unrelated to the performance and function of the on-x valve.Atherosclerotic disease leading to arteriosclerotic obstruction and eventually lower extremity amputations.None of this is related to the performance or function of the on-x prosthesis.No further action is required at this time.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: ONX AORTIC PROSTHETIC HEART VALVE
• 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: 7613026
• MDR Text Key: 111455131
• Report Number: 1649833-2018-00119
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001464
• UDI-Public: 851788001464
• 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: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2023
• Device Model Number: ONXACE-23
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/04/2018
• Date Manufacturer Received: 06/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR