MAUDE Adverse Event Report: MEDTRONIC, INC. OPEN PIVOT STANDARD AORTIC HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 500FA

Device Problem Material Deformation (2976)

Patient Problems Aortic Valve Stenosis (1717); Stroke/CVA (1770)

Event Date 01/03/2013

Event Type  Injury  

Manufacturer Narrative

Citation: niclauss l et al.Aortic biological valve prosthesis in patients younger than 65 years of age: transition to a flexible age limit? interact cardiovasc thorac surg.2013 apr;16(4):501-7.Doi: 10.1093/icvts/ivs514.Epub 2013 jan 3.Earliest date of publish used for event date.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding aortic biological valve prosthesis versus mechanical valve prothesis in patients younger than 65 years of age.All data were collected from a single center between january 2000 and december 2010.The study population included 224 patients (84 bioprosthetic group, 140 mechanical group) whom were predominantly female with an overall meanage 53 years.Two of the 84 patients in the bioprosthetic group were implanted with medtronic freestyle, and an unspecified number of the 140 patients in the mechanical group were implanted with medtronic ats open pivot.No serial numbers were provided.Among all patients, four early deaths and 16 late deaths occurred.Early in-hospital deaths included two in bioprosthetic group (hemorrhage after ascending aortic rupture, and severe sepsis), and two in the mechanical group (non-cardiac-related).During follow-up there were eight deaths in the bioprosthetic group (3 extracardiac, 1 cardiac, 4 unknown), and eight in the mechanical group (causes not provided).No further details were provided on these deaths.Based on the available information medtronic product was not directly associated with the death(s).Among all bioprosthetic valve patients, adverse events included: reoperation for pure structural valve degeneration, stroke, transient ischemic attack (tia), aneurysm, stenosis, and endocarditis.Among all mechanical valve patients, adverse events included: reoperation rate for prosthetic dysfunction, and major late neurological complications (ischemic or hemorrhagic stroke).Based on the available information medtronic product may have been associated with the adverse event(s).No additional adverse patient effects or product performance issues were reported.

• Brand Name: OPEN PIVOT STANDARD AORTIC HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer (Section G): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10261042
• MDR Text Key: 200226134
• Report Number: 3008592544-2020-00036
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P990046
• 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
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 500FA
• Device Catalogue Number: 500FA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2020
• 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): Life Threatening; Required Intervention
• Patient Age: 53 YR