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

Model Number 30525

Device Problem Material Deformation (2976)

Patient Problems Stroke/CVA (1770); Congestive Heart Failure (1783)

Event Date 09/01/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Title: efficacy of stentless aortic bioprosthesis implantation for aortic stenosis with small aortic annulus citation: thorac cardiovasc surg 2015;63:446¿451 authors: takashi murashita, yukikatsu okada, hideo kanemitsu, naoto fukunaga, yasunobu konishi, ken nakamura, tadaaki koyama month and year of publish used for event date.No unique device identifier (serial/lot) numbers were provided; without this information it cannot be determined whether this event has been previously reported.

Event Description

Medtronic received information via literature review that a study was performed to investigate long-term impact of stentless aortic bioprosthesis on clinical outcomes compared with stented aortic bioprosthesis.The study population included 140 patients (predominantly female, mean age of 73 years), 69 of which were implanted with a medtronic stentless bioprosthesis (serial numbers not provided) and 71 of which were implanted with a medtronic stented bioprosthesis (serial numbers not provided).Among all patients three early deaths occurred due to low output syndrome (2) and stroke (1), and twelve late deaths occurred (four cardiac and eight non-cardiac) without causes provided.One of the late deaths due to congestive heart failure was deemed valve-related.Among all patients seven adverse events occurred which included: stroke (3), readmission for congestive heart failure (3) and structural valve deterioration requiring reoperation (1).No additional adverse patient effects were reported.

Event Description

Additional information received from the physician stated that medtronic product did not cause or contribute to a death or other adverse event, no serial number identifiers were available, and no product was available for return to medtronic.

Manufacturer Narrative

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

• 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: 5287181
• MDR Text Key: 33259985
• Report Number: 2025587-2015-01310
• 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: Initial,Followup,Followup
• Report Date: 12/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2015
• 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
• Date Manufacturer Received: 12/10/2015
• 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: 00073 YR