MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MELODY TRANSCATHETER PULMONARY VALVE; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

Model Number PB 10

Device Problems Gradient Increase (1270); Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Aortic Regurgitation (1716); Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Hemorrhage/Bleeding (1888); Low Cardiac Output (2501); Vascular System (Circulation), Impaired (2572); Blood Loss (2597)

Event Date 06/12/2019

Event Type  Injury  

Manufacturer Narrative

Citation: duncan a et al.Outcomes following transcatheter aortic valve replacement for degenerative stentless versus stented bioprostheses.Jacc cardiovasc interv.2019 jul 8;12(13):1256-1263.Doi: 10.1016/j.Jcin.2019.02.036.Epub 2019 jun 12.Earliest date of publish used for event date.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.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding a comparison of the outcomes in patients with degenerated stentless or stented aortic bioprosthetic valves who underwent valve-in-valve transcatheter aortic valve replacement (tavr).All data were collected from multiple centers between 2007 and 2016.The study population included 1,598 (predominantly male; mean age 76 years), 377 of which were previously implanted with medtronic mosaic (161), hancock (138), freestyle (75), and ats 3f (3) bioprosthetic valves; 804 were implanted valve-in-valve with medtronic corevalve (528), evolut r (270), and melody (6) transcatheter valves.No serial numbers were provided.Among all corevalve and evolut r patients, 38 deaths occurred within 30 days post implant.No other details were reported.Based on the available information, medtronic product was not directly associated with the deaths.Among the entire study cohort, 74 patients died within 30 days post-tavr implant and 211 died within 1-year post-tavr implant, respectively.Based on the available information, medtronic product was not directly associated with the deaths.Among all mosaic, hancock, freestyle, and ats 3f patients, adverse events included: valve-in-valve implantation due to aortic regurgitation (mild-moderate-severe), aortic stenosis, or a combination of both, and high peak/mean aortic gradients.Based on the available information, medtronic product may have been associated with the adverse events.Among all corevalve, evolut r, and melody patients, adverse events included: new permanent pacemaker implantation, major stroke, second transcatheter valve required, coronary obstruction, mild-moderate-severe aortic regurgitation/paravalvular leak, prosthesis-patient mismatch, valve malposition (low/high implant), valve migration during index procedure (1 reported corevalve case), major bleeding, major vascular complications, decreased left ventricular ejection fraction, and elevated peak/mean aortic gradients.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.

• Brand Name: MELODY TRANSCATHETER PULMONARY VALVE
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• 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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8838733
• MDR Text Key: 152614107
• Report Number: 2025587-2019-02385
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P140017
• 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: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PB 10
• Device Catalogue Number: PB 10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2019
• Initial Date FDA Received: 07/29/2019
• 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 Age: 76 YR