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

Model Number 305-23

Device Problem Gradient Increase (1270)

Patient Problems Aortic Valve Stenosis (1717); Calcium Deposits/Calcification (1758); Congestive Heart Failure (1783)

Event Date 06/01/2016

Event Type  Injury  

Manufacturer Narrative

Title: transcatheter valve unable to cure patient's prosthesis mismatch of mosaic bioprosthesis citation: thoracic and cardiovascular surgeon reports (2016) (doi 10.1055/s-0036-1583298) authors: daniela serio, andreas zierer, mirko doss, anton moritz the earliest date of e-publish/publish used for event date no unique device identifier (serial/lot) numbers were provided; without this information it cannot be determined whether this event has been previously reported.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 review that one year after the implant of this 23 mm mosaic bioprosthetic surgical aortic valve, that had been implanted due to stenosis of the native aortic valve, increased gradient measurements ( 38 mm hg) were noted.The gradients immediately post implanted were not reported.No treatment was prescribed.Three years after the implant, the patient presented with symptom of left sided heart failure.An echocardiogram indicated calcified leaflets, stenosis and increased gradient measurements.Subsequently, a non medtronic transcatheter aortic valve was implanted valve-in-valve.No adverse patient effects were reported.

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: 5973283
• MDR Text Key: 55469038
• Report Number: 2025587-2016-01513
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 305-23
• Device Catalogue Number: 305-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2016
• 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: 73 YR
• Patient Weight: 80