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 date accepted by publisher used for event date.

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 +/- 17 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 24 (male, (b)(6)) was implanted with a medtronic 25-mm bioprosthetic valve in the aortic position.Thrombosis was diagnosed 599 days post-implant.Further evaluation revealed increased gradients and immobile cusps 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: 5088817
• MDR Text Key: 26226131
• Report Number: 2025587-2015-00994
• 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

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2015
• Supplement Dates Manufacturer Received: 09/30/2015
• Supplement Dates FDA Received: 09/19/2017
• 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: 00055 YR