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

Model Number UNKNOWN

Device Problem Torn Material (3024)

Patient Problems Congestive Heart Failure (1783); Mitral Regurgitation (1964)

Event Date 06/19/2014

Event Type  Injury  

Event Description

Medtronic received information via literature review that three years following implantation of a 27-mm bioprosthetic valve (serial not reported), a (b)(6) female patient presented with decompensated heart failure and severe mitral regurgitation.At reoperation, the valve was noted as calcified with a tear in one leaflet.No additional adverse patient effects were reported.No further details were provided.

Manufacturer Narrative

(b)(4).Title: early bioprosthetic valve failure: a pictorial review of rare causes authors: paul c.Cremer, md, l.Leonardo rodriguez, md, brian p.Griffin, md, carmela tan, md, rene rodriguez, md, douglas r.Johnston, md, gosta b.Pettersson, md, venu menon, md citation: jacc: cardiovascular imaging, volume 8, issue 6, june 2015, pages 737¿740.(b)(4).

Manufacturer Narrative

Conclusion: no device was returned and no unique device identifier numbers were provided.Based on the available information a review of the device history record could not be performed and root cause could not be identified.

Event Description

Requests for additional information provided no further details.

Manufacturer Narrative

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

• 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 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: 4926586
• MDR Text Key: 6433474
• Report Number: 2025587-2015-00767
• 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: Literature,Health Professional,health professional,lit
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/28/2015

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 Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/22/2015
• Initial Date FDA Received: 07/20/2015
• Supplement Dates Manufacturer Received: 07/28/2015
• Supplement Dates FDA Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: No
• 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: 00062 YR