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

Model Number 310

Device Problem Gradient Increase (1270)

Patient Problems Mitral Regurgitation (1964); Stenosis (2263)

Event Date 07/10/2018

Event Type  Injury  

Manufacturer Narrative

Citation: hu, j.Md et al.Transcatheter mitral valve implantation for degenerated mitral bioprostheses or failed surgical annuloplasty rings: a systematic review and meta-analysis.Journal of cardiac surgery.Sep;33(9):508-519 epub 2018 jul 10.Doi 10.1111/jocs.13767.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via a meta-analysis literature review regarding the implant of transcatheter bioprosthetic valves implanted into failed mitral valves and rings.All data were collected from a pubmed search of articles published between 2000 and march 2018.Sixty-six articles were identified.The overall population included 245 patients.Eighteen patients were implanted with a melody transcatheter bioprosthetic pulmonary valve, implanted in the mitral position.The remaining patients were implanted with a non-medtronic transcatheter bioprosthetic valve.It was reported that the both mosaic and hancock mitral valves had been replaced during the valve-in-valve implants.Serial numbers were not provided.The study population was predominantly male; mean age 73 ± 12.1 years.Among all patients, no deaths were attributed to a medtronic product.Among all patients with a previously implanted mosaic or hancock mitral surgical valve, adverse events included; mitral stenosis, increased mean gradients and mitral regurgitation treated with a valve-in-valve procedure.Based on the available information, these events may have been attributed to a medtronic product.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: 8220684
• MDR Text Key: 132201257
• Report Number: 2025587-2019-00081
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2019
• 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: 12/11/2018
• 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: 73 YR