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

Model Number FR995

Device Problems Hole In Material (1293); Material Perforation (2205)

Patient Problem Cusp Tear (2656)

Event Date 03/03/2014

Event Type  Injury  

Event Description

Medtronic received information that approximately 30 months after the implant of this bioprosthetic heart valve the device was explanted due to cuspal tears of the left coronary leaflet.At explant, a non-coronary sinus hole also was observed.The device was replaced with a mechanical heart valve.No adverse patient effects were reported.

Manufacturer Narrative

The product has been returned and analysis is in progress.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.A supplemental report will be filed upon completion of the analysis and investigation.(b)(4).

Manufacturer Narrative

Upon receipt at medtronic¿s quality laboratory, visual examination of the device was performed.All leaflets were slightly stiff but flexible.Two tears were observed in the belly of the left cusp but the origin / cause could not be determined.The edges of the tears were jagged showing possible evidence the tears which may have increased in size during explant.The tissue around the tears appeared thin and expanded.There was no evidence of visible mineralization or host tissue that may have contributed to the tears.The wall of the non-coronary sinus appears thin with a large tear that may be evidence of a possible pseudoaneurysm.Traces of pannus were observed on the outflow adjacent to the right cusp and left right commissure.Radiography performed showed no calcification in any leaflets.However, the sewing ring was everted on all cusps.The ifu notes to 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.It also cautions, do not invert the bioprosthesis when suturing.Inversion may result in elongated suture holes, tears, and/or distortion leading to stenosis and incompetence.In addition to the returned product analysis, the valve was sent to histopathology.The histopathological evaluation show degenerative changes observed microscopically within the non-coronary cusp sinus wall were suggestive of mechanical stress or traction on the bioprosthesis.The left cusp leaflet tear was consistent with localized abrasion/mechanical trauma as collagen degeneration was limited to that site and was not present to a notable degree in the balance of the left leaflet or within the other two cusps.There was no calcification present in the tissues examined microscopically.There was no evidence of infection in the sections examined.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.Conclusion: based on the received information, histopathological evaluation, and the returned product analysis, the definitive cause of the cuspal tears cannot be determined.However, due to the sewing ring eversion (all cusps), it could damage the valve tissue and result in tears.Medtronic will continue to monitor field performance for similar events should they occur.

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: mike gaffney ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635265629
• MDR Report Key: 3708852
• MDR Text Key: 4263082
• Report Number: 2025587-2014-00166
• 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
• Report Date: 04/18/2014

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: 04/05/2016
• Device Model Number: FR995
• Device Catalogue Number: FR995-29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2014
• Initial Date FDA Received: 03/28/2014
• Supplement Dates Manufacturer Received: Not provided; 04/18/2014
• Supplement Dates FDA Received: 04/23/2014; 09/14/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/26/2011
• 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: 00054 YR