MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION 27MM MOSAIC AORTIC VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 042364027

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atrial Fibrillation (1729); Bradycardia (1751); Pleural Effusion (2010); Ulceration (2116); Cardiac Tamponade (2226)

Event Date 01/15/2003

Event Type  Injury  

Event Description

Medtronic received information of operative complications associated with devices from this model family of aortic heart valve prostheses.The information was from a medical journal article published in 2003 that examined if the type of implanted heart valve prosthesis maximized early left ventricular mass regression after aortic valve replacement for stenotic valvular disease.The study covered 39 patients implanted with a heart valve prosthesis over a 19-month period between october 1998 and april 2000 from a candidate pool of 56 patients.The article listed the following operative complications for devices from this model family in the study: three occurrences of atrial fibrillation and one occurrence each of temporary pacing, reoperation for tamponade, pleural effusion, stroke and peptic ulceration.

Manufacturer Narrative

An author of the article was unable to provide additional information regarding these complications or other unattributed complications that were potentially device- or procedure-related, as he did not retain the data needed to answer the follow-up questions.Without device-identifying information, it could not be determined if previous complaints had been received regarding these products, or if any of the devices were subsequently explanted and returned for analysis.(b)(4).Article: does the type of prosthesis influence early left ventricular mass regression after aortic valve replacement? assessment with magnetic resonance imaging authors: penelope r.Sensky, mrcp; mahmoud loubani, frcs; richard p.Keal, frcr; nilesh j.Samani, frcp; andrew w.Sosnowski, frcs; and manuel galinanes, frcs american heart journal, october 2003 volume 146, number 4 doi:10.1016/s0002-8703(03)00253-9.

Manufacturer Narrative

Conclusion: a device history record review could not be performed as unique device identifier numbers were not provided.With the limited information received, a root cause could be determined.

Manufacturer Narrative

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

• Brand Name: 27MM MOSAIC AORTIC 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: 4528204
• MDR Text Key: 18778822
• Report Number: 2025587-2015-00231
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,foreign,health profe
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2015

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: 042364027
• Device Catalogue Number: 042364027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2015
• Initial Date FDA Received: 02/19/2015
• Supplement Dates Manufacturer Received: Not provided; 03/16/2015
• Supplement Dates FDA Received: 04/10/2015; 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: 00063 YR