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

Model Number 30525

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atrial Fibrillation (1729); Stroke/CVA (1770); Unspecified Infection (1930); Pleural Effusion (2010); Blood Loss (2597); Complete Heart Block (2627)

Event Date 03/23/2016

Event Type  Injury  

Manufacturer Narrative

Citation: a.Shalabi et al."sutureless versus stented valve in aortic valve replacement in patients with small annulus" ann thorac surg 2016;102:118¿23.Doi: http://dx.Doi.Org/10.1016/j.Athoracsur.2016.01.003 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.(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding sutureless versus stented valve in aortic valve replacement in patients with small annulus.All data were collected from a single center between december 2011 and october 2014.The study population included 44 patients (predominantly female, mean age 78 years), 2 of which were implanted with medtronic mosaic valve (serial numbers not provided).Among all patients adverse events included: stroke, respiratory failure, wound infection, bleeding, pleural effusion, atrial fibrillation without pacemaker, and complete atrioventricular block with pacemaker implant.Based on the available information, these events may have been attributed to medtronic product.

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: 6687841
• MDR Text Key: 79118536
• Report Number: 2025587-2017-01095
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2017

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?: No
• Initial Date Manufacturer Received: 06/15/2017
• Initial Date FDA Received: 07/05/2017
• Supplement Dates Manufacturer Received: 06/15/2017
• Supplement Dates FDA Received: 09/07/2017
• 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): Life Threatening; Required Intervention
• Patient Age: 78 YR