MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MEDTRONIC SURGICAL MECHANICAL VALVE; HEART-VALVE, MECHANICAL

Model Number MDT-MECH VALVE

Device Problems Degraded (1153); Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Endocarditis (1834); Valvular Insufficiency/ Regurgitation (4449)

Event Date 05/11/2021

Event Type  Injury  

Manufacturer Narrative

Citation: feier h, grigorescu a, falnita l, rachita o, gaspar m, luca ct.Long-term results (up to 20 years) of 19 mm or smaller prostheses in the aortic position.Does size matter? a propensity-matched survival analysis.Journal of clinical medicine.2021; 10(10):2055.Https://doi.Org/10.3390/jcm10102055.Earliest date of publish used for date of event.Medtronic products referenced: (b)(4).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 long-term outcomes of small prosthesis implantation in the aortic position.All data were collected from a single center between 2000 and 2018.The study population included 670 patients (predominantly female, mean age 65years).Medtronic valves that were implanted include: open pivot (37), med hall (11), advantage (4), hancock ii (74), and freestyle (6).The remaining patients were implanted with a non-medtronic valve.No serial numbers were provided.Among all patients, no deaths were attributed to a medtronic device.Among all patients, adverse events included: patient-prosthesis mismatch (ppm), valve degeneration.Other adverse events included endocarditis and severe paravalvular leak (pvl) treated with reoperation.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: MEDTRONIC SURGICAL MECHANICAL VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• 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: 12450573
• MDR Text Key: 270787436
• Report Number: 2025587-2021-02774
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P990046
• 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: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: MDT-MECH VALVE
• Device Catalogue Number: MDT-MECH VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 65 YR