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

Model Number UNKNOWN

Device Problems Gradient Increase (1270); Material Too Rigid or Stiff (1544)

Patient Problem Thrombosis (2100)

Event Date 04/07/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Title: misconceptions, diagnostic challenges and treatment opportunities in bioprosthetic valve thrombosis: lessons from a case series citation: european journal of cardio-thoracic surgery 2015 47: 725¿32 (doi:10.1093/ejcts/ezu201) authors: sorin v.Pislarua, imad hussaina, patricia a.Pellikkaa, joseph j.Maleszewskib, richard d.Hannaa, hartzell v.Schaffc and heidi m.Connollya.

Event Description

Medtronic received information via literature review of a retrospective study performed to evaluate the timing, diagnostic criteria, and treatment strategies for thrombosis in bioprosthetic valves.The study population included data from 31 patients (predominantly female; mean age 60 +/- 7 years) from one center between 1997 and 2013.Fifteen of these patients were implanted with medtronic bioprosthetic valves from two device families (serial numbers not reported) in the aortic/atrio-ventricular (n=8), mitral (n=6), and pulmonary (n=1) positions.Patient 26 (male, (b)(6)) was implanted with a medtronic 25-mm bioprosthetic valve in the aortic position.Thrombosis was diagnosed 1429 days post-implant.Further evaluation revealed increased gradients and thickened cusps with decreased mobility which was treated surgically.No additional adverse patient effects were reported.Additional information has been requested.

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.

• Brand Name: MOSAIC
• 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: 5088819
• MDR Text Key: 26226622
• Report Number: 2025587-2015-00995
• 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: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2015
• 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