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

Model Number 305U

Device Problems Material Separation (1562); Unintended Movement (3026)

Patient Problems Aneurysm (1708); Dysphasia (2195); Shaking/Tremors (2515)

Event Date 03/23/2015

Event Type  Injury  

Event Description

Medtronic received information that one year nine months post implant of this 23 mm bioprosthetic aortic valve, this valve was explanted and replaced with a 23 mm medtronic bioprosthetic aortic root heart valve after the patient presented with trembling and slurred speech.A transesophageal echocardiogram (tee) showed an aneurysm and dehiscence of the valve; the tee also showed the valve "rocking in place," however, aortic insufficiency was not present.No product performance allegations were received, and no adverse patient effects were reported.

Manufacturer Narrative

The device has not been returned.Without return of the product, no definitive conclusions can be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.(b)(4).

Manufacturer Narrative

The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.

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 STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 4795539
• MDR Text Key: 5818698
• Report Number: 2025587-2015-00595
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2016
• Device Model Number: 305U
• Device Catalogue Number: 305U225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/28/2011
• 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: 00079 YR
• Patient Weight: 88