MAUDE Adverse Event Report: BIOSTABLE HAART 200 AORTIC ANNULOPLASTY DEVICE; AORTIC ANNULOPLASTY RING

Model Number HAART 200-25 SIZE 25 MM

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

Patient Problems Cusp Tear (2656); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 12/11/2023

Event Type  Injury  

Event Description

The manufacturer was informed of an intra-operative explant of a haart 200 25 mm device occurred on (b)(6) 2023.The device had been implanted on (b)(6) 2023 in a very young patient with bicuspid native valve and severe ar on regular follow up since birth.Patient was a smoker and had no symptoms.Pre-operative toe performed in october showed aor 4+ (fused cusp prolapse, eccentric jet, 160° - kerchove type a), in absence of stenosis and calcification.The following parameters were also measured: aortic annulus 38 mm, root 42 mm and stj 32 mm.A previous cardiac mri performed in (b)(6) 2023 had shown the following values: anulus 32 mm, root 41 mm, stj 31 mm, ascao 30 mm, arch 25 mm; ef 55%, edv 258 ml.Reportedly, the implant procedure was performed through sternotomy with no complications.The lightly calcified raphe was shaved and the non-fused leaflet plicated with two stitches (prolene 6/0).Haart 200 device was implanted with ti-cron 3/0.The patient was discharged at home on the 5th pod.The following parameters were measured through tte on the 3rd pod: fe 50%, edv 250 ml.No aor, vmax 1.7 m/sec.As reported, at the follow up performed 2 months after the surgery the following parameters were measured through tte/toe: fe 50%, edv 256 ml.Aor 4+ (pht 200 msec).A complete fused leaflet flail was observed.The patient was clinically asymptomatic.An aortic valve replacement with a mechanical prosthesis (st.Jude regent 23 mm) was thus performed on (b)(6) 2023 through re-sternotomy.Intra-operatively, no haart device dehiscence was observed while the fused leaflet was ruptured at the base, still attached at the commissures.The surgery was conducted with no complications and the patient was discharged at home in the 8th pod.

Manufacturer Narrative

This report is submitted on behalf of corcym inc.Authorization letter has been submitted to fda through esg account corcym-lm18.H3 other text : unknown disposition.

Manufacturer Narrative

The manufacturing and material records for the haart 200 aortic annuloplasty device size 25, lot # 01-01096, 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 # 200-25) haart 200 aortic annuloplasty device size 25 at the time of manufacture and release.Since the device involved in the reported event was not returned for analysis, the manufacturer couldn't perform further investigation on the device.Based on the available information, the definite root cause of the reported event could not ultimately be established.According to the case description, it is reasonable to assume that the predominant factor leading to the reported event may have been a high degree of stress on the tissue due to the reported significant myocardial contractility, combined with an upper-limit ring size.In addition, on the basis of the intra-operative images captured at the time of the reoperation which were provided to the manufacturer, a potential interference of the device with the leaflets cannot be ruled out.The manufacturer will submit a follow up report in case any new information will be received.

• Brand Name: HAART 200 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: 18823317
• MDR Text Key: 336732665
• Report Number: 3004478276-2024-00119
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171431
• 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
• 2 Devices were Involved in the Event: 1 2

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 200-25 SIZE 25 MM
• Device Catalogue Number: HAART 200-25
• Device Lot Number: 01-01096
• Was Device Available for Evaluation?: No
• 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?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2022
• 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: 18 YR
• Patient Sex: Male
• Patient Weight: 79 KG