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

Model Number FR995

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aortic Regurgitation (1716); Ventricular Tachycardia (2132); Pseudoaneurysm (2605)

Event Date 11/27/2016

Event Type  Injury  

Manufacturer Narrative

Product analysis: the device is undergoing an evaluation but has not yet been completed.Conclusion: upon conclusion of the product analysis and investigation, a supplemental report will be submitted.

Event Description

Medtronic received information that 1 year and 11 months post implant of this aortic bioprosthetic valve, echocardiogram revealed severe central regurgitation and enlarging false aneurysms.The patient sustained ventricular tachycardia requiring defibrillation, was moved to the cardiac intensive care unit, had a second episode, and was successfully resuscitated with no neurological deficit.Immediately following, this valve was emergently explanted and replaced.No other adverse patient effects were reported.

Manufacturer Narrative

Product analysis: the device was received in a blood tainted solution in a specimen container enclosed in a small bio hazard bag in an explant kit.The valve appeared to have been modified with the non-coronary and left cusp buttons cut out.The aortic wall appeared slightly dilated.There appeared to be two visible areas of ruptures consistent for a pseudoaneurysm adjacent to two sinuses of valsalva.The edges appeared rolled and smooth suggesting an adventitial hemorrhage.Both holes or cut-outs on the two sinuses appeared slightly large.Minor stress marks were noted on the intima where the edges appeared rolled.All leaflets were stiff but slightly flexible except where host tissue extended on the outflow of the right cusp.All leaflets were intact.All commissures were intact.A thin layer tan thrombotic appearing host tissue lined the left cusp along the outflow margin of attachment.Radiography showed no evidence of mineralization in the valve.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.

Manufacturer Narrative

Conclusion: a visual examination of the device was performed upon receipt.The aortic wall appeared slightly dilated.There appeared to be two visible areas of ruptures adjacent to two sinus of valsalva (non-coronary sinus and left coronary sinus).Both ¿holes or cut outs¿ on the two sinuses appeared slightly large.Minor stress marks were noted on the intima where the edges appeared rolled.All leaflets and commissures were intact.The analysis also confirmed a layer of tan thrombotic host tissue lined on the left cusp along the outflow margin of attachment.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.In addition to returned product analysis, the valve was sent to histopathology.The histopathological evaluation showed there was fibrous host tissue (pannus) on the non-coronary rolled edge and left coronary sinus that caused a change in shape of those segments.There was also minimal to mild fibrin along the outflow surface of all leaflets.Minimal host inflammatory cell infiltration, adjacent host tissue, right cusp and left cusp leaflets.Based on the received information, histopathological evaluation, and the returned product analysis, the reported regurgitation likely due to the pseudoaneurysm.The definitive cause of the pseudoaneurysm cannot be determined.It has been confirmed that no infection was found.However, it cannot be ruled out whether there are any underlying inflammation responses at play for the cause.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.

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: 6172073
• MDR Text Key: 62311842
• Report Number: 2025587-2016-02018
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970031
• 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,Followup,Followup
• Report Date: 06/13/2017

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2019
• Device Model Number: FR995
• Device Catalogue Number: FR995-29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2016
• Initial Date FDA Received: 12/13/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 06/13/2017
• Supplement Dates FDA Received: 01/02/2017; 05/08/2017; 06/14/2017; 09/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2014
• 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: 51 YR