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

Model Number FR995-23

Device Problems Material Perforation (2205); Insufficient Information (3190)

Patient Problems Corneal Pannus (1447); Aortic Regurgitation (1716); Calcium Deposits/Calcification (1758); Cusp Tear (2656); No Information (3190)

Event Date 10/24/2018

Event Type  Injury  

Manufacturer Narrative

Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that 19 years and 3 months post implant of this bioprosthetic aortic valve, it was explanted and replaced with a bioprosthetic valve of a different model.The reason for replacement is unknown.No additional adverse patient effects were reported. .

Manufacturer Narrative

Added expiration date and added device manufacture date.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information was received that approximately 19 years post implant of this 23mm bioprosthetic aortic root, the patient developed progressive dyspnea on exertion and severe insufficiency.19 years and 3 months post implant the patient underwent re-operation.During the operation, the bioprosthetic root was noted be severely calcified.Approximately 4mm circumferential cicatrix of calcific pannus was present at the inflow portion of the original prosthesis.This was excised.Multiple endarterectomies were performed for calcific nodules present within the bioprosthetic root.Additionally, a perforation in the belly of the left coronary leaflet of the bioprosthetic root, as well as a torn leaflet on the noncoronary cusp were identified.The surgeon felt the severe insufficiency was due to these findings.The leaflets of the original bioprosthesis were excised.The surgeon "opened" the noncoronary sinus of the root, and a 19mm bioprosthetic aortic valve was implanted within the previous bioprosthetic root.The area of the aortic root that was "opened" was patched.The patient's native tricuspid valve was severely insufficient, and during the procedure "significant" annular dilation of the tricupsid valve was noted.A 28mm annuloplasty ring was implanted."minimal" tricuspid regurgitation was noted with saline testing.After removal of cardiopulmonary bypass, transesophageal echocardiogram (tee) illustrated "trivial" regurgitation.No interventions were performed to address this.No additional adverse patient effects were reported.  if information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic received additional information that approximately 19 years post implant of this 23mm bioprosthetic aortic root, the patient developed progressive dyspnea on exertion and severe insufficiency.19 years and 3 months post implant the patient underwent re-operation.During the operation, the bioprosthetic root was noted be severely calcified.Approximately 4mm circumferential cicatrix of calcific pannus was present at the inflow portion of the original prosthesis.This was excised.Multiple endarterectomies were performed for calcific nodules present within the bioprosthetic root.Additionally, a perforation in the belly of the left coronary leaflet of the bioprosthetic root, as well as a torn leaflet on the noncoronary cusp were identified.The surgeon felt the severe insufficiency was due to these findings.The leaflets of the original bioprosthesis were excised.The surgeon "opened" the noncoronary sinus of the root, and a 19mm bioprosthetic aortic valve was implanted within the previous bioprosthetic root.The area of the aortic root that was "opened" was patched.Corrected from previously submitted regulatory report #2025587-2018-03210, follow up 002.Removed annuloplasty ring information that did not pertain to a reportable event.Device code added.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• 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
• MDR Report Key: 8109490
• MDR Text Key: 128560781
• Report Number: 2025587-2018-03210
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00681490265904
• UDI-Public: 00681490265904
• Combination Product (y/n): N
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2003
• Device Model Number: FR995-23
• Device Catalogue Number: FR995-23
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 85