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

Model Number MDT-TISSUE VALVE

Device Problem Insufficient Information (3190)

Patient Problems Atrial Fibrillation (1729); Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Hemorrhage/Bleeding (1888); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 01/25/2020

Event Type  Injury  

Event Description

Medtronic received information from a literature article regarding the patient outcomes following redo surgical aortic valve replacement (redo-savr) compared to valve-in-valve transcatheter aortic valve replacement (viv-tavr).All data was retrospectively collected from a single center between 2012 and 2019.The overall study population included 273 patients (redo-savr = 86, viv-tavr = 187).In the redo-savr group (predominantly male, mean age 61.3 years), 29 patients were implanted with a medtronic surgical valve: freestyle (n = 24) or mosaic (n = 5).In the viv-tavr group (predominantly male, mean age 73 years), one patient was previously implanted with a freestyle surgical valve, while 7 patients were implanted with a medtronic transcatheter valve: corevalve (n = 6) or evolut r (n = 1).No unique device identifier numbers were provided.Among all 273 patients in the study population, overall five-year survival was 88.3% for the redo-savr group and 95.8% for the viv-tavr group.No statement was made suggesting a causal or contributory relationship between medtronic product and the deaths.Among all 273 patients in the study population, adverse events included: stroke; prolonged ventilation; myocardial infarction; atrial fibrillation; new permanent pacemaker implantation; mechanical circulatory support; bleeding; transfusion; reoperation for bleeding; central aortic regurgitation (redo-savr = mild, viv-tavr = mild to moderate); and need for aortic valve reoperation/reintervention.The patient previously implanted with a freestyle surgical valve underwent vivi-tavr with an edwards sapien 3 bioprosthesis.The time to reintervention was 32.9 months post-implant and was because of bioprosthetic valve dysfunction causing aortic insufficiency.Medtronic product may have been associated with the adverse events.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Citation: patel pm, et al.Isolated redo aortic valve replacement versus valve-in-valve transcatheter valve replacement.Ann thorac surg.2021 aug;112(2):539-545.Doi: 10.1016/j.Athoracsur.2020.08.048.Epub 2020 oct 28.Presented at the poster session of the fifty-sixth annual meeting of the society of thoracic surgeons, new orleans, la, jan 25-28, 2020.Earliest date of presentation used for date of event.Medtronic products referenced: freestyle (pma# p970031, product code lwr), mosaic (pma# p990064, product code dye).Earliest approved product used for product code and pma#.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: MEDTRONIC SURGICAL TISSUE 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12823359
• MDR Text Key: 281083816
• Report Number: 2025587-2021-03458
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MDT-TISSUE VALVE
• Device Catalogue Number: MDT-TISSUE VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2021
• 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): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male