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

Model Number 305U

Device Problem Bent (1059)

Patient Problem Aortic Regurgitation (1716)

Event Date 08/30/2016

Event Type  Injury  

Manufacturer Narrative

Product analysis: the device remains implanted.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Should additional information become available, a supplemental report will be submitted.

Event Description

Medtronic received information that on the day of implant of this aortic bioprosthetic valve, a post operative echocardiogram showed significant aortic regurgitation and a possible bent strut.The physician reopened the patient's aorta and determined that problem was paravalvular leak.The physician placed an additional suture to resolve the paravalvular leak.The patient was taken off and put back on cardiopulmonary bypass (cpb) four times during the procedure.The device remains implanted.The facility reported that the patient was able to sit up in a chair 24 hours after surgery.

Manufacturer Narrative

The investigation for this product event has been completed: paravalvular leak (pvl) can be caused by a variety of factors, including valve positioning due to implant procedure, patient anatomy, or presence of pre-existing patient conditions; implant technique may be causing the pvl in this case from the limited information available.

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: 5956867
• MDR Text Key: 54942749
• Report Number: 2025587-2016-01478
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2017
• Device Model Number: 305U
• Device Catalogue Number: 305U229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/22/2012
• 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: 59 YR