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

Model Number MDT-TISSUE VALVE

Device Problem Migration (4003)

Patient Problems Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Cardiovascular Insufficiency (4445); Valvular Insufficiency/ Regurgitation (4449)

Event Date 01/05/2021

Event Type  Injury  

Manufacturer Narrative

Citation: landes et al.Transcatheter replacement of transcatheter versus surgically implanted aortic valve bioprostheses.J am coll cardiol.2021 jan 5;77(1):1-14.Doi: 10.1016/j.Jacc.2020.10.053.Earliest date of publish used for date of event.Medtronic surgical valves referenced: freestyle (pma# (b)(4), product code lwr), hancock ii (pma# (b)(4), product code dye), and mosaic (pma# (b)(4), 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.

Event Description

Medtronic received information via literature regarding transcatheter valve-in-valve implants into transcatheter aortic valve (tav) or surgical aortic valve (sav) bioprostheses.All data were collected from a registry database between april 2005 and april 2019.The initial study population included 658 patients (tav-in-tav=434, tav-in-sav=624), which was characterized as predominantly male with a mean age of 80 years.For propensity matched comparison the population was distilled down to 330 patients with 165 in each the tav-in-tav and tav-in-sav groups.Multiple manufacturer¿s devices were implanted in the study population, which included medtronic surgical valves freestyle (n=4), hancock ii (n=12), and mosaic (n=5) as well as medtronic transcatheter valves corevalve (n=90), evolut r (n=64), and evolut pro (n=5).No unique device identifier numbers were provided for any of the valves.Among all patients, mortality rates at 30 days were 3% (n=5) in tav-in-tav patients and 4.4% (n=7) in tav-in-sav patients.At 1 year follow-up, mortality rates were 11.9% (n=12) and 10.2% (n=10), respectively.Based on the available information medtronic product was not directly associated with the death(s).Among all patients implanted with either a surgical and transcatheter valve, adverse events included: intervention requiring implant of a second prosthetic valve, mean aortic valve gradient as high as 35 mmhg, moderate to severe aortic regurgitation (ar), stroke, myocardial infarction (mi), valve embolization/migration, coronary obstruction, conversion to open heart surgery, major vascular complication, major bleeding, and arrhythmia requiring new permanent pacemaker implant.Based on the available information medtronic product may have been associated with the adverse event(s).No additional adverse patient effects or product performance issues were reported.

• 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: 12285525
• MDR Text Key: 265370510
• Report Number: 2025587-2021-02474
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• 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: 07/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 80 YR