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

Model Number FR995

Device Problem Material Perforation (2205)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/01/2015

Event Type  Injury  

Manufacturer Narrative

Product analysis: no product specimen has been returned.Conclusion: attempts to obtain additional information and device return have been unsuccessful.Without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.The event date is approximate, as attempts to gather the actual date have been unsuccessful.(b)(4).

Event Description

Medtronic received information that following implant of this bioprosthetic aortic root valve, it was explanted due to a perforation of the valve.The implant duration was not provided.No adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information that this event occurred three years, seven months following implant of this bioprosthetic aortic root valve.Upon explant a perforation was observed in the aortic root at the coronary portion of the valve, straight above both coronary vessels.Date of event updated in device model #, catalog #, serial # and expiration date added.Device implant date added.Device explant date added.

Manufacturer Narrative

Conclusion: 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.The product specimen was not returned for physical examination; however, a translated histology report and photographic images were received for review.Because the device was sutured and in-situ while the photographs were taken, the reported perforation could not be identified or observed.Based on the information received from the site this event potentially describes a typical pseudoaneurysm event.An extensive review was performed regarding this type of pseudoaneurysm (perforation) which included re-examining the quality of the porcine tissue (tissue thickness), the tissue treatment process and all subsequent manufacturing steps.Based on this review, it was concluded that pseudoaneurysm formation is not directly related to any limitations within the manufacturing process.This investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.Potential root causes to the reported issue may have been attributed to implant techniques, including: misalignment of coronary arteries resulting in tension on the anastomotic site ¿failure to adequately mobilize the coronary buttons to prevent tension on the anastomoses.Oversizing the anastomotic site ¿ sewing to thin tissue as a result of creating an extensive or low button hole in the sinus of the device.Iatrogenic (needle size too large) - multiple unnecessary needle punctures at the wall and/or coronary button site.Used surgical tissue adhesives, such as bioglue.The use of surgical tissue adhesives could cause undesirable histological effects (i.E.Tissue necrosis) on native aortic tissue.

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 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: 5179283
• MDR Text Key: 29288200
• Report Number: 2025587-2015-01117
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P970031
• 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,Followup,Followup
• Report Date: 03/23/2016

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2017
• Device Model Number: FR995
• Device Catalogue Number: FR995-29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2015
• Initial Date FDA Received: 10/26/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; 03/23/2016
• Supplement Dates FDA Received: 11/02/2015; 04/01/2016; 09/19/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/28/2012
• 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