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

Model Number FR995-29

Device Problems Material Erosion (1214); Hole In Material (1293)

Patient Problems Bradycardia (1751); Thrombus (2101); Pseudoaneurysm (2605); Complete Heart Block (2627)

Event Date 12/16/2014

Event Type  Injury  

Event Description

Medtronic received information that this aortic root bioprosthesis was explanted approximately 18 months after implant due to thrombus and erosion of the device wall.No device anomalies had been observed at the scheduled six-month follow-up.Approximately 12 months later, an echocardiogram showed a false aneurysm with demonstrable blood flow into it.The patient also was in complete heart block with a heart rate of 40 beats per minute (bpm).A temporary pacing wire was implanted to provide pacing support at 60 bpm.There were no signs of infection, but antibiotics were administered as a precautionary preventive measure.At explant, there were three small holes found in the device and in the native aortic wall containing the device, and clots filling the space between the device and the native tissue.The holes were unassociated with any suture line, and tests showed no evidence of infection or any organisms.A different device of the same model and size was successfully implanted.No subsequent adverse patient effects were reported.

Manufacturer Narrative

It was reported that the device will be returned for analysis.A supplemental report will be filed when the analysis/investigation is completed.(b)(4).

Manufacturer Narrative

The device has been returned for analysis.Analysis is ongoing.A supplemental report will be filed when the analysis/investigation is completed.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.

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, visual inspection of the device indicated the sewing ring to be slightly everted.Per the instructions for use (ifu), ¿bioprosthesis implantation- take care not to evert (roll outward) the inflow end of the bioprosthesis when suturing the valve to the patient¿s annulus.Eversion could damage the valve tissue.¿ the aortic wall appeared slightly dilated.Three visible areas of ruptures, consistent for a pseudoaneurysm adjacent to all three sinus of valsalva, were present.The edges appeared rolled and smooth, suggesting ¿adventitial hemorrhage¿.The larger hole on the right sinus extended to the edge of the sewing cloth.Minor stress marks were noted on the intima where another part of the edge appears rolled.All leaflets were stiff but slightly flexible, except where host tissue extended on the outflow of the right cusp.All leaflets were intact.An intracuspal hematoma was observed on the tunica of the right cusp.All commissures were intact.A thin layer of pannus extended onto the inflow of the right cusp.A layer of tan thrombotic appearing host tissue lined the belly of the right cusp.Off-white friable, non-vegetative appearing tissue was observed on the outer wall of the valve.Radiography showed no evidence of mineralization in the valve and/or host tissue.Conclusion: product analysis indicated the right cusp was stretched where the largest hole was located.It¿s possible that the right cusp being stretched like this may have put more tension on the right cusp sinus area where the largest hole was located.The analysis also confirmed a layer of tan thrombotic host tissue lined the belly of the right cusp.Based on the received information and the returned product analysis, the definitive cause of the ruptures was unable to 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.Journal articles suggest several possible contributing causes of freestyle rupture.The ozaki paper lists embryologic anatomic weakness and tension by fluid collections in the non-coronary sinus as possible causes.In one patient, the immunologic biocompatibility of the valve was questioned.Medtronic will continue to monitor field performance for similar events should they occur.Ozaki,n., hino,y., hanafusa,y., yamsahita,t., okada,k., tsukube,t., and okita,y.Perforation of the valsalva sinus after implantation of medtronic freestyle aortic bioprosthesis.The society of thoracic surgeons.82:2282-2285.2006.

Manufacturer Narrative

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 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: 4408360
• MDR Text Key: 5432235
• Report Number: 2025587-2015-00067
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2018
• Device Model Number: FR995-29
• Device Catalogue Number: FR995-29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/31/2013
• 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: 00050 YR