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

Model Number 310

Device Problems Degraded (1153); Perivalvular Leak (1457)

Patient Problems Endocarditis (1834); Hemorrhage/Bleeding (1888); Insufficiency, Valvular (1926); Sepsis (2067); Thrombosis (2100); Low Cardiac Output (2501); Blood Loss (2597); Thromboembolism (2654)

Event Date 10/11/2019

Event Type  Injury  

Manufacturer Narrative

Citation: lorusso r et al.Mitral valve replacement with a third generation porcine valve: an italian multicentered study.Ann thorac surg.2019 oct 11.Pii: s0003-4975(19)31568-1.Doi: 10.1016/j.Athoracsur.2019.08.111.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 the 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 the outcomes in patients who underwent mitral valve replacement with the mosaic porcine bioprosthesis.All data were retrospectively collected from 11 centers between january 1998 and december 2011.The study population included 805 patients and was predominantly female with a mean age of 74 years and a mean weight of 67 kg.All were implanted with medtronic mosaic bioprosthetic valves in the mitral position.Valve sizes used: 25, 27, 29, 31, and 33 mm.No serial numbers were provided.Among all patients, approximately 9 valve-related deaths were reported to have occurred within 10 years post-implant.Based on the available information, medtronic product was directly associated with these 9 deaths.In addition, approximately 60 cardiac-related deaths occurred within 10 years post-implant.No other details were reported pertaining to these cardiac-related deaths.Other causes of death noted: multi-organ failure (12), sepsis (6), cerebral bleeding (2), and pulmonary thromboembolism (1).Based on the available information, medtronic product was not directly associated with these combined 81 deaths.Among all patients, adverse events included: reoperation, structural valve degeneration/deterioration (type of degeneration not provided), bleeding requiring chest re-exploration surgery, neurological events, endocarditis, thromboembolic events, hemorrhagic events, intestinal ischemic events, sepsis, valve thrombosis, paravalvular leak, and low cardiac output.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, 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: 9382807
• MDR Text Key: 168219421
• Report Number: 2025587-2019-03612
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• 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: 11/19/2019
• 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: 67