MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION HANCOCK AORTIC BIOPROSTHETIC HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 242

Device Problems Degraded (1153); Fluid/Blood Leak (1250); Device Stenosis (4066)

Patient Problems Stenosis (2263); Valvular Insufficiency/ Regurgitation (4449)

Event Date 01/09/2023

Event Type  Injury  

Manufacturer Narrative

Citation: pravda et al.Transcatheter interventions for atrioventricular dysfunction in patients with adult congenital heart disease: an international case series.J clin med.2023 jan 9;12(2):521.Doi: 10.3390/jcm12020521.Earliest date of publication used for date of event.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Literature was reviewed regarding case reports of intervention for atrioventricular dysfunction in adult patients with congenital heart disease.  case 3:  a female patient with history of ebstein anomaly and a mechanical tricuspid valve replacement with subsequent atrioventricular block requiring a permanent pacemaker.  later, during pregnancy, the patient had a non-obstructive stuck valve requiring implant of a medtronic 31 mm hancock bioprosthesis.  twenty-three years later the patient presented with structural valvedeterioration with moderate regurgitation and stenosis. subsequently the patient underwent a valve-in-valve implant of non-medtronic 29 mm bioprosthesis inside the hancock bioprosthesis, resulting in no residual regurgitation and a mean gradient of 2 mmhg.Case 4:  a male patient with history of rastelli repair operation with symptomatic bradycardia requiring an epicardial pacemaker, pulmonary homograft implant, tricuspid valve repair, and closure of ventricular septal defect.  in the following years the tricuspid valve deteriorated and was treated by implant of medtronic 33mm hancock bioprosthesis. more recently the patient presented with episodes of ventricular tachycardia, congestive heart failure, and tricuspid structural valve deterioration, regurgitation, and stenosis. the patient underwent tricuspid valve-in-a valve implant of a non-medtronic 29 mm bioprosthesis inside the hancock bioprosthesis, resulting in in no residual tricuspid regurgitation.Case 9:   a female patient with a history of surgically corrected transposition of the great vessels, implant of a mechanical valve with subsequent thrombosis treated with implant of a medtronic 25mm hancock bioprosthesis, and atrioventricular block requiring a permanent pacemaker.  more recently the patient presented with symptoms of decompensated heart failure, regurgitation, and high transvalvular gradient of 22 mmhg.  a hemodynamic catheterization demonstrated pulmonary hypertension with mixed valvular dysfunction.  subsequently the patient underwent a valve-in-valve implant of a non-medtronic 26 mm bioprosthesis inside the hancock bioprosthesis, resulting in improved gradients.  following the procedure the ventricular function did not improve. however, at the 6-month follow up, the patient reported a subjective improvement and was noted as clinically stable.  no further information was provided pertaining to medtronic products.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HANCOCK AORTIC BIOPROSTHETIC HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18794496
• MDR Text Key: 336396229
• Report Number: 2025587-2024-01191
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P980043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 242
• Device Catalogue Number: 242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2024
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Sex: Female