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

Model Number 30525

Device Problem Material Integrity Problem (2978)

Patient Problem Endocarditis (1834)

Event Date 04/01/2014

Event Type  Injury  

Manufacturer Narrative

Citation: glaser n, franco-cereceda a, sartipy,u.Ann thorac surg 2014; 97:1314¿21 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 this event has been previously reported.

Event Description

Medtronic received information via literature review regarding a study performed to compare outcomes following aortic valve replacement (avr) with an edwards perimount versus a medtronic mosaic bioprosthesis.The study population included 1,219 patients (predominantly male; mean age 73.6 years), 355 of which were implanted with medtronic mosaic bioprosthesis (serial numbers not provided) at a single swedish institution between 2002 and 2010.During a mean follow-up of 4.2 and 6.9 years, there were 177 deaths in the mosaic group.The unadjusted survival at 1, 5, and 8 years was 92%, 80%, and 57%, respectively, in the mosaic group.None of the deaths were attributed to medtronic product.Among all patients in the mosaic group, the unadjusted freedom from reoperation at 1, 5, and 8 years was 99.7%, 98.4%, and 97.0%, respectively.A total of 10 patients required reoperation with explantation or a valve-in-valve procedure: 8 due to unspecified structural valve dysfunction (svd) and 2 due to endocarditis.Reoperation for svd within 48 months was performed in 3 patients.No additional adverse patient effects were reported.

Manufacturer Narrative

Correction: including article title in citation.Glaser n, franco-cereceda a, sartipy,u.Late survival after aortic valve replacement with the perimount versus the mosaic bioprosthesis.Ann thorac surg 2014; 97:1314¿21.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: MOSAIC AORTIC 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: 5586105
• MDR Text Key: 42940641
• Report Number: 2025587-2016-00556
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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,Followup,Followup
• Report Date: 04/18/2016

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: 30525
• Device Catalogue Number: 30525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2016
• Initial Date FDA Received: 04/18/2016
• Supplement Dates Manufacturer Received: Not provided; 04/18/2016
• Supplement Dates FDA Received: 04/18/2016; 09/21/2017
• Was Device Evaluated by Manufacturer?: No
• 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: 00074 YR