MAUDE Adverse Event Report: MEDTRONIC, INC. AORTIC AP; HEART-VALVE, MECHANICAL

Model Number 501DA

Device Problem Material Integrity Problem (2978)

Patient Problems Aortic Insufficiency (1715); Aortic Valve Stenosis (1717); Endocarditis (1834)

Event Date 01/17/2016

Event Type  Injury  

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.(b)(4).

Event Description

Medtronic received information that 7 years and 9 months post implant of this mechanical valve, it was replaced with a larger mechanical valve due to severe aortic insufficiency, endocarditis, dehiscence, and stenosis.The patient was hospitalized for eight weeks prior to the procedure due to endocarditis and treated with antibiotics.The procedure was performed without complications; however, each of the above mentioned adverse patient effects remained.

Manufacturer Narrative

Additional information was received indicating that endocarditis was deemed the main reason for replacement and was the cause of secondary symptoms.Blood cultures were positive and enterococci were identified.Product analysis: the product specimen has been discarded by the medical institution.Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.In this event, the occurrence of the reported endocarditis was greater than 12 months post implant.Based on the descriptive comments outlined from journal literature, complaints which occurred greater than 12 months post implant were largely considered to be community acquired (refer to note 1 below).Therefore, it was unlikely that the endocarditis originally came from the device and/or manufacturing valve process.Considering the information available, a relationship between the device and the reported heart failure and coronary artery disease could not be established.Without the return of the valve, a conclusive cause could not be determined.Note 1 - mylonakis, e., and calderwood, s.B.Infective endocarditis in adults.New england journal of medicine.345 (18).1318-1330.Nov.1, 2001.

Manufacturer Narrative

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

• Brand Name: AORTIC AP
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• 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: 5457349
• MDR Text Key: 38906012
• Report Number: 3008592544-2016-00010
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2012
• Device Model Number: 501DA
• Device Catalogue Number: 501DA22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2007
• 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): Hospitalization; Required Intervention
• Patient Age: 00054 YR
• Patient Weight: 128