MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MOSAIC PORCINE HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 310F31

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Information (3190)

Event Date 01/01/2010

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: fr99525, serial/lot #: (b)(4), udi#: (b)(4), pma/510(k): p970031.Event date and explant dates are year valid only.Product analysis: no products were returned.One of the products remains in the patient.Conclusion: 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 approximately 4 years and 9 months post implant of this bioprosthetic mitral valve and bioprosthetic full aortic root valve, both valves were replaced.The mitral valve was explanted and replaced with a mechanical valve.The aortic valve remained implanted, but a non-medtronic mechanical valved conduit was implanted inside the aortic root prosthesis.It was reported that at the time of explant the patient had "ripping of the porcine valve".Both medtronic valves (mitral and aortic) are porcine valves.As such, it is unclear which valve, or if both valves, "ripped".No additional adverse patient effects were reported. .

• Brand Name: MOSAIC PORCINE HEART VALVE
• 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: 10455390
• MDR Text Key: 204410803
• Report Number: 2025587-2020-02679
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 310F31
• Device Catalogue Number: 310F31
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2020
• 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: 38 YR
• Patient Weight: 91