MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MOSAIC AORTIC BIOPROSTHETIC HEART VALVE; TIMER, CLOT, AUTOMATED

Model Number 30525

Device Problem Insufficient Information (3190)

Patient Problem Thrombus (2101)

Event Date 03/24/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Title: early stenosis of an aortic porcine bioprosthesis due to thrombosis: case report and literature review citation: j thorac cardiovasc surg 2015;149:e83-6 (http://dx.Doi.Org/10.1016/j.Jtcvs.2015.02.039) authors: masahiro dohi, md, kiyoshi doi, md, phd, and hitoshi yaku, md, phd date of publish used for event date.

Event Description

Medtronic received information via literature review of an article describing early stenosis and thrombosis of aortic bioprosthetic valves.The case report within the article did not reference medtronic products, however a table summary reference 18 medtronic surgical bioprosthetic valves from two device families (serial numbers not reported) noted with early thrombosis (excluding patients on anticoagulation or thrombolytic therapy).Per the table summary, the patients with medtronic valves had a mean age of 70.5 years, and a mean time from implant to thrombosis occurrence of 40.7 months.Of these 18 patients, all but four were noted as having undergone intervention to replace the thrombotic valve.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 AORTIC BIOPROSTHETIC HEART VALVE
• Type of Device: TIMER, CLOT, AUTOMATED
• 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: 5084311
• MDR Text Key: 26050377
• Report Number: 2025587-2015-00981
• Device Sequence Number: 1
• Product Code: GKN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/29/2015

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: 30525
• Device Catalogue Number: 30525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2015
• Supplement Dates Manufacturer Received: 09/29/2015
• 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: 00071 YR