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

Model Number 500FA

Device Problem Gradient Increase (1270)

Patient Problems Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Endocarditis (1834); Myocardial Infarction (1969); Thrombosis (2100)

Event Date 01/28/2020

Event Type  Injury  

Manufacturer Narrative

Citation: tzamalis p et al.Comparison of valve durability and outcomes of transcatheter aortic valve implantation versus surgical aortic valve replacement in patients with severe symptomatic aortic stenosis and less-than-high-risk for surgery.Am j cardiol.2020 apr 15;125(8):1202-1208.Doi: 10.1016/j.Amjcard.2020.01.015.Epub 2020 jan 28.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 the return of the product, no definitive conclusion can be made regarding the clinical observations.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding an examination of the rate of severe structural valve deterioration and long-term outcomes in patients with severe symptomatic aortic stenosis who underwent transcatheter aortic valve implantation (tavi) or surgical aortic valve replacement (savr).All data were collected from a single center between may 2007 and april 2012.The study population included 432 propensity score matched patients (216 tavi patients, 216 savr patients) and was predominantly female with a mean age of 78 years.In the tavi cohort, 36 patients were implanted with medtronic corevalve transcatheter valves.In the savr cohort, 74 patients were implanted with medtronic hancock ii surgical valves and 4 were implanted with medtronic ats (open pivot) mechanical valves.No serial numbers were provided.Among all tavi patients, 4 deaths were attributed to unspecified bioprosthetic valve dysfunction.The type of transcatheter valve ( corevalve, sapien/sapien xt, accurate, or jena valve) that was implanted in these 4 patients was not reported.Based on the available information, medtronic product was not directly associated with these 4 deaths.Among all tavi and savr patients, 204 all-cause deaths occurred during the mean follow-up period of 6.6 years.No further details were provided.Based on the available information, medtronic product was not directly associated with these deaths.Among all tavi and savr patients, adverse events included: new permanent pacemaker implantation, stroke, myocardial infarction, unspecified bioprosthetic valve dysfunction, endocarditis, thrombosis, aortic valve re-intervention, unspecified major adverse cardiac events/cardiovascular events, elevated mean trans-prosthetic gradient (ranging from 20 mmhg to above 40 mmhg), and moderate-severe paravalvular aortic regurgitation (only observed in tavi patients).Based on the available information, medtronic product may have been associated with the adverse events.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: 10017570
• MDR Text Key: 196775427
• Report Number: 3008592544-2020-00031
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 05/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2020
• 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: 04/22/2020
• 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): Required Intervention
• Patient Age: 78 YR