MAUDE Adverse Event Report: ABBOTT MEDICAL BIOCOR¿ VALVE (AORTIC); HEART-VALVE, NON-ALLOGRAFT TISSUE

Catalog Number B100-23A

Device Problem Incomplete Coaptation (2507)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/02/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2023, a 23mm stented porcine,aor,bioc or was selected for an implant.After implantation of the valve, the physician closed the incision of heart.The physician found that the systolic peak velocity was greater than 5 m/s during the transesophageal echocardiogram (tee).The valve have difficulty closing and opening completely.The physician stopped the blood circulation and opened the heart incision again.The physician explanted the valve and found that 2/3 tissue fixation ring moved inward about 2-3mm, which blocked the blood to flow through the tissue valve, and led to the high blood velocity.The physician replaced with a 23mm regent heart valve w/flex cuff valve instead.At last the procedure was finished successfully without patient consequence.The patient remain hemodynamically stable through the implant and explant procedure.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2023, a 23mm aortic stented epic biocor valve was selected for an implant in a patient with a history of aortic valve insufficiency, liver malignant tumor, liver cirrhosis, chronic viral hepatitis b.The physician took out the valve with complete external package without any issues.During the procedure, the physician block the ascending aorta according to the normal procedure process, inject histidine-tryptophan-ketoglutarate (htk) cardioplegia, penetrate into the valve for knotting and fixation.The tested valve was well opened and closed and the device was implanted.After implantation of the valve, the physician closed the incision of heart.Ultrasound showed that the peak systolic velocity of aortic bioprosthesis was more than 5 m/s, which was ineffective after repeated drug and hemodynamic adjustment.The valve have difficulty closing and opening completely.The ascending aorta was immediately re-blocked, htk cardioplegia was perfused, and the bioprosthesis was removed.The physician found that 2/3 tissue fixation ring moved inward about 2-3mm, which blocked the blood to flow through the tissue valve, and led to the high blood velocity.The physician replaced with a 23mm regent heart valve w/flex cuff valve instead.At last the procedure was finished successfully without patient consequence.No paravalvular leakage was observed, the peak systolic velocity of the mechanical valve of the aortic valve was 2.7 m/s, and the mean transvalvular pressure gradient was about 16 mmhg.The above adverse event prolonged the procedure time by about 1 hour and 30 minutes, interfered with the normal operating procedures of the surgeon, and because the patient's age was suitable for the bioprosthesis, the bioprosthesis was removed and a mechanical valve was implanted, resulting in that the patient needed to take anticoagulant drugs for life after the operation.The patient is stable.

Manufacturer Narrative

An event of difficulty opening and closing of the valve was reported.No anomalies were found with the valve cusps, and functional testing at the time of manufacturing and upon return to abbott indicated the valve functioned normally.This test ensures proper cuspal coaptation and hemodynamic performance.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: BIOCOR¿ VALVE (AORTIC)
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL LTDA. REG#3001883144; 1301rua profvieira demendonça; bairro engenho nogueira 31.31 0-26; BR 31.310-260
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16976428
• MDR Text Key: 315766393
• Report Number: 2135147-2023-02243
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2023
• Device Catalogue Number: B100-23A
• Device Lot Number: BR00022539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2019
• 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 Sex: Male