MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION FREESTYLE AORTIC ROOT BIOPROSTHESIS; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 995

Device Problem Insufficient Information (3190)

Patient Problem Pseudoaneurysm (2605)

Event Date 12/01/2016

Event Type  Injury  

Manufacturer Narrative

Citation: uchida et al.Pseudoaneurysm formation after aortic root replacement using freestyle porcine bioprosthesis.Kyobu geka: the japanese journal of thoracic surgery.2016 dec; 69(13):10731076.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.

Event Description

Medtronic received information via literature regarding a (b)(6) male patient who underwent an aortic root replacement with implant of a medtronic freestyle bioprosthesis (serial number not provided).Ten years post-implant, a 6-cm wide pseudoaneurysm of the aortic root was observed by computed tomography.In a reoperation, the pseudoaneurysm was found to originate from the ruptured left and noncoronary sinuses.The aortic root was successfully reconstructed with a composite graft bearing a stented bioprosthesis.No additional adverse patient effects were reported.

Manufacturer Narrative

A review of medtronic's global complaint handling database based on this device serial number revealed this event has been previously reported.Report # (b)(4) was submitted on 2016.01.29 via asr exemption # (b)(4).

Event Description

Additional information from the physician/author provided device identification (serial number (b)(4)).No other information was provided.

Manufacturer Narrative

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

• Brand Name: FREESTYLE AORTIC ROOT BIOPROSTHESIS
• 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: 6211607
• MDR Text Key: 63468915
• Report Number: 2025587-2016-02093
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P970031
• 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: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 995
• Device Catalogue Number: 995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2017
• 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: 65 YR