MAUDE Adverse Event Report: BIOSTABLE HAART 300 AORTIC ANNULOPLASTY DEVICE; AORTIC ANNULOPLASTY RING

Model Number HAART 300-23 SIZE 23MM

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

Patient Problems Dyspnea (1816); Endocarditis (1834); Cusp Tear (2656); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 01/15/2024

Event Type  Injury  

Manufacturer Narrative

This report is submitted on behalf of corcym inc.Authorization letter has been submitted to fda through esg account (b)(4).H3 other text : evaluation is ongoing.

Event Description

The manufacturer was informed of an early explant of a haart 300 23 mm aortic annuloplasty ring.The device had been implanted on (b)(6) 2023 in a patient with moderate aortic regurgitation and aortic aneurysm in regular follow up (root 42 mm, stj 35 mm, ascao 52 mm as per ct scan performed in (b)(6) 2023).Native valve was tricuspid.The patient was a former smoker and had uncontrolled hta.Pre-operative parameters measured at toe in (b)(6) 2023 were: aor 3+, v.C.6 mm, eccentric jet, ava 2.5 cmq.Anulus 29 mm, ascao 50 mm.Non-coronary cusp fibrosis was identified.Reportedly, the implanted procedure was performed through sternotomy.Intra-operatively, partial commissural fusion (rl and nl) and minimal non coronary cusp prolapse were identified and addressed through minimal commissurotomy (rl and nl) and non-coronary cusp plication with one stitch (prolene 6/0).The haart device was implanted with ti-cron 3/0 sutures.Ascending aortic replacement with 30 mm tubular prosthesis was performed in the same procedure.As per information received, the surgery was completed without complications but the patient experienced a prolonged los due to the need for antibiotic therapy.Ms staphylococcus aureus was identified at blood cultures.Patient was discharged at home in 18th pod.3 tte performed at discharge showed no suspect signs for endocarditis and the following parameters: ef 46%, no aor, mean grad 10 mmhg, vmax 2.1 m/s; mitral regurg 2-3+.No infection at blood sample was present at discharge.Reportedly the patient was admitted to the emergency department on (b)(6) 2024 for asthenia and dispnoea.The patient didn¿t present fever.The exams performed showed bilateral pleural effusion and tte/toe showed massive aor, functional mitral regurg 4+ and left cusp flail or endocarditis on left cusp (8 mm) was suspected.The patient underwent reoperation on the same day through re-sternotomy.No haart device dehiscence was observed at the reoperation and there was no apparent infection while a complete left cusp flail and right cusp perforation at the base were observed as well as aortic annulus disjunction in all three sinus.As reported, the aortic annulus was reconstructed with three pericardial patches.Av replacement with a bioprosthesis (edwards lifesciences magna ease 23mm) and mv repair with posterior annuloplasty (edwards lifesciences physio flex 28mm) were performed.The patient was put under ecmo va due to severe lv dysfunction and successfully weaned on (b)(6) 2024 and discharged from icu on (b)(6) 2024.Intraoperative haart device culture was positive for staphylococcus epidermidis, oxacillin-resistant.The tte performed 5 days after weaning from ecmo showed a normo-functioning aortic bioprosthesis, mild mitral regurgitation, ef 45%.The patient is currently hospitalized undergoing cardiopulmonary rehabilitation.

Event Description

The manufacturer was informed of an early explant of a haart 300 23 mm aortic annuloplasty ring.The device had been implanted on (b)(6) 2023 in a patient with moderate aortic regurgitation and aortic aneurysm in regular follow up (root 42 mm, stj 35 mm, ascao 52 mm as per ct scan performed in (b)(6) 2023).Native valve was tricuspid.The patient was a former smoker and had uncontrolled hta.Pre-operative parameters measured at toe in (b)(6) 2023 were: aor 3+, v.C.6 mm, eccentric jet, ava 2.5 cmq.Anulus 29 mm, ascao 50 mm.Non-coronary cusp fibrosis was identified.Reportedly, the implanted procedure was performed through sternotomy.Intra-operatively, partial commissural fusion (rl and nl) and minimal non coronary cusp prolapse were identified and addressed through minimal commissurotomy (rl and nl) and non-coronary cusp plication with one stitch (prolene 6/0).The haart device was implanted with ti-cron 3/0 sutures.Ascending aortic replacement with 30 mm tubular prosthesis was performed in the same procedure.As per information received, the surgery was completed without complications but the patient experienced a prolonged loss due to the need for antibiotic therapy.Ms staphylococcus aureus was identified at blood cultures.Patient was discharged at home in 18th pod.3 tte performed at discharge showed no suspect signs for endocarditis and the following parameters: ef 46%, no aor, mean grad 10 mmhg, vmax 2.1 m/s; mitral regurg 2-3+.No infection at blood sample was present at discharge.Reportedly the patient was admitted to the emergency department on (b)(6) 2024 for asthenia and dispnoea.The patient didn¿t present fever.The exams performed showed bilateral pleural effusion and tte/toe showed massive aor, functional mitral regurg 4+ and left cusp flail or endocarditis on left cusp (8 mm) was suspected.The patient underwent reoperation on the same day through re-sternotomy.No haart device dehiscence was observed at the reoperation and there was no apparent infection while a complete left cusp flail and right cusp perforation at the base were observed as well as aortic annulus disjunction in all three sinus.As reported, the aortic annulus was reconstructed with three pericardial patches.Av replacement with a bioprosthesis (edwards lifesciences magna ease 23mm) and mv repair with posterior annuloplasty (edwards lifesciences physio flex 28mm) were performed.The patient was put under ecmo va due to severe lv dysfunction and successfully weaned on (b)(6) 2024 and discharged from icu on (b)(6) 2024.Intraoperative haart device culture was positive for staphylococcus epidermidis, oxacillin-resistant.The tte performed 5 days after weaning from ecmo showed a normo-functioning aortic bioprosthesis, mild mitral regurgitation, ef 45%.The patient has been discharged from hospital in the first week of (b)(6) after completing cardiopulmonary rehabilitation.

Manufacturer Narrative

The manufacturing and material records for the haart 300 aortic annuloplasty device size 23, lot # 01-00534, involved in the reported event, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this device satisfied all material, visual, and performance standards required for a (model # 300-23) haart 300 aortic annuloplasty device size 23 at the time of manufacture and release.The device involved in the reported event was returned to the manufacturer for analysis and received in general good storage conditions with some portions of the suture stitches and some fragment of organic residue.The stitches were still connected in firm position without remarkable traces of deformation of the fabric around them and the area of endothelization appears thin and homogeneous, without signs of deformation of the fabric around and without evidences suggesting particular stresses in these areas.A small organic residue was present, reasonably attributable to pannus growth which appeared rather flat when laid out.One of the posts was deformed, bent outwards in a radial direction at such an angle that an anatomical stress could reasonably be ruled out.It is therefore reasonable to associate this deformation with the explantation manoeuvres performed.Based on the information reported to the manufacturer, at the time of implant the patient experienced a prolonged hospitalization due to the need to administer antibiotic therapy to treat ms staphylococcus aureus which was isolated in blood cultures.It was also reported that, despite there were no evident signs of infection at the time of reoperation, intraoperative device culture was positive to staphylococcus epidermidis oxacillin-resistant.It should be noted that staphylococcus epidermidis is a gram-positive bacterium which accounts for 65-90% of all staphylococci found on the skin, in the vagina, urethra and oral cavity in humans.This bacterium tends to cause harm in surgically implanted individuals.Staphylococcus aureus, is a gram-positive bacterium that can be present on human skin and mucous membranes and can cause a variety of infections in humans.Staphylococcal infections are often transmitted in hospitals, as this bacterium is one of the main culprits of nosocomial infections.Staphylococcus species can be killed by 8 kgy gamma.The haart 300 devices are sterilized using at least 25 kgy, as such it can be reasonably excluded a relationship between the device and the reported infections.As a result of the investigation, the manufacturing and material records for the haart 300 aortic annuloplasty device involved in the reported event has confirmed that the device satisfied all required material, visual, and performance standards at the time of manufacture and release and the inspection performed on the returned device didn't show any sign suggestive of a possible relationship of the event with the device quality.Based on the above considerations and according to the manufacturer's experience, the root cause of the reported event can be reasonably attributed to the endocardities, which has been instrumental in altering the physiology of the tissues, leading to their weakening.In addition, the hypertensive factor may have acted as a concomitant cause, having contributed to increased stress on the tissues.As such, the root cause of the reported event should be traced to patient-related factors.

• Brand Name: HAART 300 AORTIC ANNULOPLASTY DEVICE
• Type of Device: AORTIC ANNULOPLASTY RING
• Manufacturer (Section D): BIOSTABLE; 2621 ridgepoint dr. suite 100; austin TX 78754
• Manufacturer (Section G): CORCYM INC.; 9800 mount pyramid court, suite 400; englewood CO 80112
• Manufacturer Contact: laura mannino ; 9800 mount pyramid court, suite 400; englewood, CO 80112
• MDR Report Key: 18823313
• MDR Text Key: 336742017
• Report Number: 3005687633-2024-00101
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163608
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HAART 300-23 SIZE 23MM
• Device Catalogue Number: HAART 300-23
• Device Lot Number: 01-00534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 88 KG