MAUDE Adverse Event Report: CRYOLIFE, INC. ¿ AUSTIN ON-X ASCENDING AORTIC PROSTHESIS WITH THE VASCUTEK GELWEAV UNKNOWN CONFIGURATION; HEART-VALVE, MECHANICAL

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Embolism (1829)

Event Type  Death  

Manufacturer Narrative

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

Event Description

According to initial information from abstract: rf08 bentall operation with on-x mechanical conduit: the bologna experience: murana, g.; mariani, c.; alfonsi, j.; fiorentino, m.; coppola, g.; folesani, g.; leone, a.; suarez, s.Martin; pacini, d.; di bartolomeo, r.Background and aim: the on-x prosthesis is the only mechanical aortic valve available in the market to have a proved safety and feasibility at lower inr regimen.The aims of this retrospective study were to evaluate the early and mid-term outcomes of the modified bentall procedure with the o4n-x mechanical conduit.Methods: from january 2012 to december 2016, 108 consecutive patients (mean age 51.9 ± 12.5 years) underwent bentall operation with on-x in our institution.Main indications were degenerative ascending aorta aneurysms (55.6%) and aortic dissections (20.4%).Seventeen (15.7%) were redo operations.Associated procedures were performed in 40 cases (37.0%); of them, 27 (25.0%) were complete or partial arch replacements.Mean follow-up time was 35.1 ± 16.1 months (97.1% complete).After 2015, a lower inr regimen of 1.5 to 2 was applied in association with aspirin.Results: overall in-hospital mortality was 2.8%.Morbidity included: 1 stroke (0.9%), 2 acute kidney injuries (2.9%) and 5 re-thoracotomies for bleeding (4.6%).Actuarial survival at 5 years was 95.2 %.Freedom from aortic re-operation was 100%.At 5 years no thromboembolic or haemorrhagic events were observed and only 1 patient had an infective endocarditis (figure 1).Conclusions: the modified bentall operation confirmed to be a safe and durable operation for the treatment of ascending aorta pathologies.The on-x conduit showed very satisfactory early results even in cases with unfavourable anatomy.This prosthesis also guarantees safe mid-term durability associated with a very low incidence of thromboembolism regardless of the lower inr regimen.

Manufacturer Narrative

According to initial reports, abstract - rf08 bentall operation with on-x mechanical conduit_ the bologna experience - journal of cardiovascular medicine - ¿overall in-hospital mortality was (b)(4).Morbidity included: (b)(4) stroke(b)(4) (b)(4) acute kidney injuries (2.9%) and 5 re-thoracotomies for bleeding(b)(4) actuarial survival at 5 years was (b)(4).Freedom from aortic re-operation was (b)(4).At 5 years no thromboembolic or haemorrhagic events were observed and only (b)(4) patient had an infective endocarditis.¿ attempts for additional information have gone unmet.The product will not be returned.Without the return of the product, no definitive conclusion can be made regarding the clinical observations.If information is provided in the future, a supplemental report will be issued.A review of manufacturing records could not be performed as a definitive serial number was not provided.A review of the available information was performed.This is an abstract prepared for presentation describing a single center experience from (b)(6)2012 to (b)(6)2016 with the on-x ascending aortic prosthesis (onxaap) on 108 consecutive patients undergoing the bentall operation.Results: overall in-hospital mortality was (b)(4).Morbidity included: (b)(4) stroke (b)(4) }, (b)(4) acute kidney injuries (b)(4) and 5 re-thoracotomies for bleeding(b)(4) actuarial sunival at 5 years was (b)(4).Freedom from aortic re-operation was(b)(4).At 5 years no thromboembolic or haemorrhagic events were obsened and only 1 patient had an infective endocarditis.The modified bentall operation was confirmed to be a safe and durable operation for the treatment of ascending aorta pathologies.The on-x conduit showed very satisfactory early results even in cases with unfavourable anatomy.This prosthesis also guarantees safe mid-term durability associated with a very low incidence of thromboembolism regardless of the lower inr regimen.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 (instructions for use).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 GELWEAV UNKNOWN CONFIGURATION
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): CRYOLIFE, INC. ¿ AUSTIN; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 10308902
• MDR Text Key: 199892328
• Report Number: 1649833-2020-00024
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• 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: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/20/2020
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Other; Required Intervention