MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MOSAIC AORTIC BIOPROSTHETIC HEART VALVE; HEART-VALVE, REPLACEMENT

Model Number 305C227

Device Problems Mechanical Problem (1384); Material Puncture/Hole (1504); Structural Problem (2506); Mechanics Altered (2984)

Patient Problems Failure of Implant (1924); No Information (3190)

Event Date 06/20/2018

Event Type  Injury  

Manufacturer Narrative

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 immediately post implant of this 27 mm aortic bioprosthetic valve in a patient with a large aortic annulus and small sinotubular junction, the valve was tested and found to be performing as expected.An unknown time post operatively, functioning of the valve was found to be inadequate."mechanical" damage during the implant is believed to have caused improper valve functioning.The surgeon was unable to provide additional details surrounding the damage.The patient was brought back into the operating room and the valve removed and replaced with a valve of the same size and model.No additional adverse patient effects were reported. .

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, visual inspection revealed that the stent post appeared slightly distorted.A cut was observed at approximately 10mm long on the outer cloth of the right non-coronary stent post.There was damage to the outflow rail adjacent to the left cusp (lc), as well as damage to the sewing cuff adjacent to the left right (lr) stent post.All leaflets were slightly stiff but flexible.All leaflets are in a semi - relaxed position which is a normal finding for this valve as it is processed with the leaflets in relaxed state.A tear along the belly of the right cusp (rc) of approximately 9mm long was observed.All commissures were found to be intact.The device was visually inspected by manufacturing quality and confirmed the damage on the leaflet.Due to the leaflet tear, functional testing could not be performed.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.Prior to release for distribution, each mosaic valve must pass tests to ensure coaptation and leaflet characteristics meet specification.Therefore, it is unlikely that the tear occurred during manufacturing or prior to distribution.Based on the received information and analysis of the returned device, the clinical observation was confirmed.The probable cause of the tear is the valve accidentally coming in contact with a sharp instrument.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: MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
• Type of Device: HEART-VALVE, REPLACEMENT
• 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: 7682757
• MDR Text Key: 113810023
• Report Number: 2025587-2018-01737
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2023
• Device Model Number: 305C227
• Device Catalogue Number: 305C227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2018
• 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: 56 YR