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According to the initial report received via email on 20-aug-2020 the surgeon explanted an onx aortic valve due to leaking.The onx aortic was replaced with another manufacturer's valve.Additional information received from the surgeon's office relay this is a (b)(6) yr.Old male with 30-pack-year cigarette use, social alcohol consumption, goiter, hoshimoto thyroiditis and sciatica.At 5 years of age underwent closure of vsd.Patient experiencing decline in stamina, and dyspnea on exertion.Sob walking up 1 flight of stairs.2015 placement of stent in the circumflex artery.Tee performed on (b)(6) 2019 showed sever aortic regurgitation with dilatation in the sinus of valsalva.On (b)(6) 2019 onxace 27/29 sn: (b)(4) was implanted.Post operative tee revealed there was no aortic valve regurgitation.Due to the covid pandemic, the patient did not have a follow-up transthoracic echocardiogram.Approximately one month ago ((b)(6) 2020) the patient experienced onset of dyspnea, and was found to be in atrial fibrillation.A cardioversion was performed.On (b)(6) 2020 a transesophageal echocardiogram was performed.Aortic valve: mechanical aortic valve with rocking motion within the annulus secondary to severe partial dehiscence from the annulus near the mitral valve with severe peri-valvular regurgitation, unstable mechanical valve.On (b)(6) 2020 the onxace 27/29 was explanted and replaced with another manufacturer's valve.
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Correction to b3 and d4.According to the initial report received via email on (b)(6) 2020 from (b)(6), cryolife representative, (b)(6) explanted an onx aortic valve due to leaking.The onx aortic was replaced with another manufacturer's valve.Additional information received from (b)(6) office relay this is a male with 30-pack-year cigarette use, social alcohol consumption, goiter, hoshimoto thyrioditis and sciatica.At 5 years of age underwent closure of vsd.Patient experiencing decline in stamin, and dyspnea on exertion.Sob walking up 1 flight of stairs.2015 placement of stent in the circumflex artery.Tee performed on (b)(6) 2019 showed sever aortic regurgitation with dilatation in the sinus of valsalva.On (b)(6) 2019 onxace 27/29 sn: (b)(6) was implanted.Post operative tee revealed there was no aortic valve regurgitation.Due to the covid pandemic, the patient did not have a follow-up transthoracic echocardiogram.Approximately one month ago (may 2020) the patient experienced onset of dyspnea, and was found to be in atrial fibrillation.A cardioversion was performed.On (b)(6)2020 a transesophageal echocardiogram was performed.Aortic valve: mechanical aortic valve with rocking motion within the annulus secondary to severe partial dehiscence from the annulus near the mitral valve with severe peri-valvular regurgitation, unstable mechanical valve.On (b)(6) 2020 the onxace 27/29 was explanted and replaced with another manufacturer's valve.No additional information is forthcoming.The manufacturing records for serial number (b)(6) 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.Onxace 27/29 sn (b)(6) was implanted (b)(6) 2019 in the aortic position of a 52 year-old male, an operation which also saw replacement of the ascending aorta with a hemashield graft.On (b)(6) 2020 (209 days post-implant) this valve was explanted and replaced by a valve from another manufacturer.Note: the valve was previously identified as onxace-27/29 sn (b)(6).The valve was returned to the manufacturer where the correct serial number was verified by physical examination.Approximately half a year post-implantation of the on-x valve, the patient described shortness of breath upon exertion.He was also found at that time to in atrial fibrillation.Then on (b)(6) 2020 a transesophageal echocardiogram revealed severe aortic regurgitation.Upon re-do surgery, the on-x valve was observed to have separated from the tissue for 1/3 of its perimeter resulting in severe paravalvular leak (pvl).It was also noted that the remaining annulus tissue was weak and degenerative and concern was expressed about its integrity to hold a new valve.Because of the degenerative nature of the tissue, samples were provided for pathological examination under the possibility of infection (endocarditis).However, the result of the pathological examination was not provided so infection was not confirmed and remains unknown.The medical evaluation evidence we have is severe paravalvular leak as a consequence of probable, though unconfirmed endocarditis.If it is endocarditis, the source is not likely to be from the on-x valve which undergoes a validated sterilization process during the manufacturing.The instructions for use [ifu] for the on-x valve acknowledge paravalvular leak as a potential complication which may lead to reoperation and explantation.Paravalvular leak occurs at an historic rate of 1.2% per valve-year for all pvls, while major degenerative annular tissue, it shows an historical rate of occurrence of 1.2% per valve-year [iso 5840:2005(e)].The cause for explantation of the on-x valve is paravalvular leak due to loss of annular tissue integrity, likely the result of infection.There is no evidence that the valve itself failed to perform as designed.No further action is required.Onxace 27/29 (b)(6) was implanted in (b)(6) 2019 in the aortic position, an operation which also saw the replacement of the ascending aorta with a hemashield graft.In (b)(6) 2020 this valve was explanted and replaced by a valve from another manufacturer.Approximately half a year post implantation the patient described shortness of breath upon exertion and was found to have atrial fibrillation.A transesophageal echocardiogram revealed severe paravalvular leak (pvl).It was also noted that the remaining annulus tissue was weak and degenerative.Due to this samples were provided for pathological examination under the possibility of endocarditis.However, the result of the pathological exam was not provided so infection was not confirmed and remains unknown.The medical evaluation evidence we have is severe pvl as a consequence of probable, though unconfirmed, endocarditis.If it is endocarditis, the source is not likely to be from the on-x valve which undergoes a validated sterilization process during manufacturing.The instructions for use (ifu) for the on-x valve acknowledge paravalvular leak as a potential complication of which may lead to reoperation and explantation.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.The root cause for this event is paravalvular leak.The cause of the paravalvular leak is loss of annular tissue possibly due to unconfirmed endocarditis.If endocarditis is the reason for the loss of annular tissue, the source is not likely to be from the on-x valve which undergoes a validated sterilization process during manufacturing.The review of the device history record indicates that the valve met all specifications for release.There is no indication that an error or deficiency occurred at cryolife and all risks identified have been mitigated as far as possible and residual risk is acceptable.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.Sample evaluation of onxace 27/29 serial number: (b)(6) performed on (b)(6) 2020: methods of evaluation: visual, function investigation, microscopy investigation/review findings: prior to decontamination, visual examination did not reveal any anomalies.Leaflets move freely and the valve rotates as intended.After decontamination, the sewing cuff was cut to expose the s/n on the housing and it was determined the part was in fact onxace 27/29 sn:(b)(6).The part was sent through inspection and testing.The valve passed all visual and functional requirements and specifications.The part was functioning as intended when returned for evaluation.
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According to the initial report received via email on (b)(6) 2020, the surgeon explanted an onx aortic valve due to leaking.The onx aortic was replaced with another manufacturer's valve.Additional information received from the surgeon's office relay this is a male with 30-pack-year cigarette use, social alcohol consumption, goiter, hoshimoto thyroiditis and sciatica.At 5 years of age underwent closure of vsd.Patient experiencing decline in stamina, and dyspnea on exertion.Sob walking up 1 flight of stairs.2015 placement of stent in the circumflex artery.Tee performed on (b)(6) 2019 showed sever aortic regurgitation with dilatation in the sinus of valsalva.(b)(6) 2019 onxace 27/29 sn: (b)(6) was implanted.Post operative tee revealed there was no aortic valve regurgitation.Due to the covid pandemic, the patient did not have a follow-up transthoracic echocardiogram.Approximately one month ago ((b)(6) 2020) the patient experienced onset of dyspnea, and was found to be in atrial fibrillation.A cardioversion was performed.On (b)(6)2020, a transesophageal echocardiogram was performed.Aortic valve: mechanical aortic valve with rocking motion within the annulus secondary to severe partial dehiscence from the annulus near the mitral valve with severe peri-valvular regurgitation, unstable mechanical valve.On (b)(6) 2020 the onxace 27/29 was explanted and replaced with another manufacturer's valve.
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