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 Insufficiency (1715); Organ Dehiscence (2502); Pseudoaneurysm (2605)

Event Date 04/06/2016

Event Type  Injury  

Manufacturer Narrative

Product analysis: the product specimen has not been returned.Conclusion: 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.

Event Description

Medtronic received information that approximately 2 years and 1 month post implant of this bioprosthetic valve, it was replaced due to an ascending aortic pseudo aneurysm and moderate paravalvular leak (pvl).The right coronary button was completely dehisced from the root, but the left coronary button suture line was intact.No further adverse patient effects were reported.

Manufacturer Narrative

Conclusion: without the device returned to medtronic, any of the clinical observations cannot be confirmed.A review of the device history record (dhr) was also performed for this valve.There were no correlations / issues identified in regard to manufacturing.The device was manufactured per approved and released manufacturing processes and the device met all applicable manufacturing specifications prior to release for distribution.With the limited received information, a root cause of the event was unable to be determined.Based on the received information, this event describes a typical pseudoaneurysm event.Medtronic previously conducted an extensive analysis ((b)(4)) including re-examining the quality of the porcine tissue (tissue thickness), the tissue treatment process and all subsequent manufacturing steps.Based upon this analysis, it was concluded that pseudoaneurysm formation is not directly related to any limitations within the manufacturing process.Implant techniques, however, could be important contributing factors: misalignment of coronary arteries resulting in tension on the anastomotic site ¿failure to adequately mobilize the coronary buttons to prevent tension on the anastomoses; over sizing the anastomotic site ¿ sewing to thin tissue as a result on creating an extensive or low button hole in the freestyle sinus; iatrogenic (needle size too large), multiple unnecessary needle punctures at the wall and/or coronary button site; surgical tissue adhesives like bioglue.While, the additional glutaraldehyde exposure from the bioglue to the freestyle tissue is irrelevant, as is the bioprosthesis is fully cross-linked, the glutaraldehyde component of the adhesive may have undesired effects on the native host tissue, including tissue necrosis.Pseudoaneurysm / pvl related risks are addressed in the current risk management file.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: 5682508
• MDR Text Key: 46020237
• Report Number: 2025587-2016-00775
• 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
• Report Date: 10/19/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2018
• 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: 05/06/2016
• Initial Date FDA Received: 05/26/2016
• Supplement Dates Manufacturer Received: Not provided; 10/19/2016
• Supplement Dates FDA Received: 10/19/2016; 09/22/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/17/2013
• 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: 63 YR
• Patient Weight: 68