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

Model Number T505

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Non specific EKG/ECG Changes (1817); Endocarditis (1834); Vascular Dissection (3160); Pericardial Effusion (3271)

Event Date 08/26/2021

Event Type  Injury  

Event Description

Medtronic received information via literature regarding patient¿s lifetime procedure load and durability who are implanted with pulmonary valve prostheses.All data were retrospectively collected from the german national register for congenital heart defects between 1957 and 2018.The study population included 997 patients (predominantly male, age ranged from less than 1 to greater than 40 years old) who underwent 1,823 pulmonary valve replacements including 226 transcatheter valve implants.Multiple manufacturer¿s devices were implanted in the study population; an unspecified number of patients were implanted with a medtronic contegra conduit or hancock bioprosthetic valve.No unique device identifier numbers were provided.Among all patients, an unspecified number of deaths occurred.No further details were provided on the deaths.There was no statement of causal or contributory relationship between medtronic product and the deaths.Among all patients, adverse events potentially associated with heart valve products included: aortic dissection requiring intervention, pericardial effusion requiring pericardiocentesis, endocarditis, arrhythmia requiring permanent pacemaker implant, stent placement in cardiac conduit, replacement of cardiac conduit or valve, and unplanned reoperation required during same admission.Based on the available information medtronic product may have been associated with the adverse events.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Citation: boethig et al.Pulmonary valve prostheses: patient¿s lifetime procedure load and durability.Evaluation of the german national register for congenital heart defects.Interact cardiovasc thorac surg.2022 jan 18;34(2):297-306.Doi: 10.1093/icvts/ivab233.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.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HANCOCK II 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: 14964609
• MDR Text Key: 295595592
• Report Number: 2025587-2022-01876
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P980043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: T505
• Device Catalogue Number: T505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2022
• 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): Congenital Anomaly; Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Male