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

Model Number 310

Device Problems Inadequacy of Device Shape and/or Size (1583); Incomplete Coaptation (2507)

Patient Problems Host-Tissue Reaction (1297); Atrial Fibrillation (1729); Embolism (1829); Endocarditis (1834); Hemorrhage/Bleeding (1888); Sepsis (2067); Thrombosis (2100)

Event Date 11/03/2000

Event Type  Injury  

Manufacturer Narrative

Citation: thomson dj et al.Medtronic mosaic porcine bioprosthesis: midterm investigational trial results.Ann thorac surg.2001 may;71(5 suppl):s269-72.Doi: 10.1016/s0003-4975(01)02551-6.Presented at the viii international symposium on cardiac bioprostheses, cancun, mexico, nov 3¿5, 2000.Earliest date of publish used for date of event.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 from a literature article regarding the mid-term clinical and hemodynamic performance of the mosaic porcine bioprosthesis.All data were collected from nine (b)(6) centers.Survival and freedom from adverse events at four years were reported.The study population included 802 patients and was predominantly male with a mean age of 69 years.Of those, 560 were implanted with the medtronic mosaic valve in the aortic position and 242 had the mosaic implanted in the mitral position.No serial numbers were provided.Among all patients, 111 deaths (38 early deaths, 73 late deaths) occurred within four years after valve implant.The freedom from v alve-related or unexplained death was 95.6% ± 1.9% (aortic) and 96.5% ± 3.4% (mitral), respectively.No further details were provided.Based on the available information, medtronic product was associated with an unspecified number of these deaths.Among all patients, adverse events included: reoperation, early or late endocarditis (unknown duration from valve implant to onset of endocarditis), major hemorrhage, major embolus, thrombosis/thromboembolism, and patient-prosthesis mismatch.Adverse events that were only observed among the aortic patients: mild aortic regurgitation.Adverse events that were only observed among the mitral patients: post-operative atrial fibrillation requiring cardioversion, staphylococcus epidermidis sepsis, and pannus formation that mildly impaired cusp movement.Based on the available information, medtronic product was associated with the adverse events.No additional adverse patient effects or product performance issues were reported.

• Brand Name: MOSAIC MITRAL BIOPROSTHETIC VALVE
• Type of Device: HEART-VALVE, REPLACEMENT
• 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: 10208705
• MDR Text Key: 201172859
• Report Number: 2025587-2020-02068
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P990064
• 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: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• 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
• Date Manufacturer Received: 06/23/2020
• 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: 69 YR