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

Model Number 310

Device Problem Obstruction of Flow (2423)

Patient Problems Mitral Regurgitation (1964); Mitral Valve Stenosis (1965)

Event Date 06/16/2017

Event Type  Injury  

Manufacturer Narrative

Citation: dvir d.Tav in mitral surgical valves and rings: lessons from the vivid registry (transcatheter mitral valve-in-valve / valve-in-ring).Presented at transcatheter valve therapies 2017.Doi: not available ¿ slide presentation attached.Earliest date of publish used for event date (presented on jun 16, 2017).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 a retrospective study of patients who underwent transcatheter mitral valve replacement of a previously implanted bioprosthetic mitral valve or annuloplasty ring.All data were collected from multiple centers through 2017.The study population included 437 patients (predominantly female; mean age 74 years; mean weight 69 kg), 67 of which were previously implanted with medtronic mosaic bioprosthetic valves, 49 were previously implanted with medtronic hancock bioprosthetic valves, 7 were previously implanted with medtronic duran ancore annuloplasty rings, and an unspecified number of which were implanted with medtronic melody bioprosthetic valves.It was also reported that 4 patients were previously implanted with ¿medtronic other¿ surgical mitral rings.No serial numbers were provided.Among all patients, the 30-day mortality rate was 8.5% and the 30-day cardiovascular mortality rate was 6.9%, respectively.Multiple manufacturers were noted in the literature; based on the available information, medtronic product was not directly associated with the deaths.Among all mosaic, hancock, duran ancore, and ¿medtronic other" patients, adverse events included: mitral stenosis, severe mitral regurgitation, or a combination of mitral stenosis and regurgitation requiring transcatheter mitral valve-in-valve or valve-in-ring implantation.Based on the available information, medtronic product was directly associated with the adverse events.Among all patients, post-transcatheter mitral valve replacement adverse events included: implantation of another transcatheter device, major stroke, left ventricular outflow tract obstruction, paravalvular leak, valve malpositioning, delayed valve malpositioning, residual stenosis, mitral regurgitation (greater than or equal to moderate), and elevated post procedural gradients.Based on the available information, the medtronic melody valve may have been associated with these adverse events.No additional adverse patient effects or product performance issues were reported.

• Brand Name: MOSAIC MITRAL 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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8755683
• MDR Text Key: 149924886
• Report Number: 2025587-2019-02134
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/02/2019

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: 310
• Device Catalogue Number: 310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2019
• Initial Date FDA Received: 07/02/2019
• 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: 74 YR
• Patient Weight: 69