MAUDE Adverse Event Report: MEDTRONIC 3F THERAPEUTICS, INC. THV 1000-29 3F AORTIC BIO 29MM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 1000-29

Device Problems Material Separation (1562); Torn Material (3024)

Patient Problem Aortic Insufficiency (1715)

Event Date 09/23/2014

Event Type  Injury  

Event Description

Medtronic received information that this aortic bioprosthetic valve was explanted 18 months after its implant due to severe insufficiency.It was reported that there were observations of a valve leaflet perforation and a small detachment of the base of the valve from the annulus.The valve was replaced with another manufacturer¿s valve with no further adverse patient effects 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

Upon receipt at medtronic¿s quality laboratory, the valve was received distorted in an oval shape.The valve tissue was desiccated.All leaflets were stiff but slightly flexible, except where the tissue was desiccated.Distortion in the valve may have contributed to a prolapsed appearance in leaflets 1 and 2.A large perforation in the belly of leaflet 2 may be associated with uneven leaflet movement that may have resulted in a hinge point.The tops of all commissures had been removed during the explant.A trace of pannus remained attached to leaflet 3 adjacent to the 3-2 commissure.A remnant of pannus on the inflow extended onto the tunica of leaflet 1from the sewing ring.A remnant of pannus remained attached to the outflow edge of the sewing ring adjacent to leaflet 2, extending to the outflow margin of attachment.Radiography showed no evidence of mineralization in the valve.

Manufacturer Narrative

Conclusion: 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.Based on the analysis, a conclusive cause of the perforation of the leaflet could not be determined.The receipt condition of the valve may have altered the gross observations.Distortion of the valve may have created uneven leaflet movement thereby contributing to the tear on the leaflet.The perforation does not appear to have been induced during the manufacturing procedure, based on the device history record review.The root cause for the reported clinical observation could not be determined.Medtronic will continue to monitor for similar events.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: THV 1000-29 3F AORTIC BIO 29MM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC 3F THERAPEUTICS, INC.; 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: 4190587
• MDR Text Key: 20979619
• Report Number: 3010152718-2014-00006
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P060025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2014
• Device Model Number: 1000-29
• Device Catalogue Number: 1000-29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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: 00075 YR