MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MEDTRONIC SURGICAL TISSUE VALVE; REPLACEMENT HEART-VALVE

Model Number MDT-TISSUE VALVE

Device Problems Gradient Increase (1270); Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Aortic Valve Stenosis (1717); Mitral Valve Stenosis (1965); Pulmonary Valve Stenosis (2024); Tricuspid Valve Stenosis (2113); Heart Failure/Congestive Heart Failure (4446); Valvular Insufficiency/ Regurgitation (4449); Aortic Valve Insufficiency/ Regurgitation (4450); Mitral Valve Insufficiency/ Regurgitation (4451); Pulmonary Valve Insufficiency/ Regurgitation (4452); Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 04/25/2015

Event Type  Injury  

Manufacturer Narrative

Citation: conradi l, et al.Transcatheter valve-in-valve therapy using 6 different devices in 4 anatomic positions: clinical outcomes and technical considerations.J thorac cardiovasc surg.2015 dec;150(6):1557-65, 1567.E1-3; discussion 1565-7.Doi: 10.1016/j.Jtcv s.2015.08.065.Epub 2015 aug 28.Read at the 95th annual meeting of the american association for thoracic surgery, seattle, washington, april 25-29, 2015.Earliest date of presentation used for date of event.Medtronic products referenced: 3f (pma# p060025, product code lwr), freestyle (pma# p970031, product code lwr), hancock (pma# p870078, product code dye), hancock ii (pma# p980043, product code dye), mosaic (pma# p990064, product code dye).Earliest approved product used for product code and pma#.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 from a literature article regarding the outcomes of transcatheter valve-in-valve (viv) implantation in all anatomic positions.All data was prospectively collected and retrospectively analyzed from a single center between 2008 and 2014.Of the 75 patients included in the study population (predominantly male, mean age 74.1 years), 32 were previously implanted with a medtronic surgical valve: 3f (1 = aortic); freestyle (1 = aortic, 2 = pulmonary); hancock (11 = aortic, 3 = mitral); hancock ii (3 = aortic, 4 = mitral); or mosaic (5 = aortic, 1 = mitral, 1 = tricuspid).The duration from surgical valve implant to viv was a mean 9.3 years.Of the 54 aortic viv procedures, 28 were performed with a medtronic transcatheter valve: corevalve (11), evolut r (15), or engager (2).No unique device identifier numbers were provided.Among all patients, two deaths occurred within 72 hours of the viv procedure.One of these deaths pertained to a patient with a det eriorated 29 mm hancock ii mitral valve (severely regurgitant, elevated gradients) presenting with cardiogenic shock and acute decompensation who underwent emergent mitral viv using a 26 mm non-medtronic transcatheter valve with adequate result.However, the patient did not recover from cardiogenic shock and died onpost-operative day three.These details suggest the hancock ii may have been a contributory factor in the death.The other death involved a transaortic viv performed via partial upper mini-sternotomy using a 23 mm corevalve into a 23 mm hancock ii.Closure of the aortic access site led to injury of a proximal aorto-coronary bypass graft and an acute myocardial infarction resulted in death on post-operative day one.Based on these details, this death was not attributed to medtronic product.An additional four all-cause deaths occurred within thirty days of viv implantation.No statement was made suggesting a causal or contributory relationship between medtronic product and these four deaths.All medtronic surgical valve patients underwent transcatheter viv implantation for valvular deterioration.The modes of deterioration consisted of stenosis, regurgitation, or mixed stenosis/regurgitation.Adverseeffects associated with the valvular deterioration included: heart failure, reduced left ventricular ejection fraction, moderate to severe regurgitation, and elevated gradients.An unspecified proportion of these patients presented with patient-prosthesis mismatch prior to viv.One case of mild paravalvular leak originating from the hancock ii valve was observed after a mitral viv procedure.Adverse events that occurred within thirty days of viv implantation included: valve embolized into the ascending aorta necessitating conversion to transapical implantation of a second valve (one evolut r case); post-implant balloon dilation for residual elevated gradients or paravalvular leakage; permanent pacemaker implantation; elevated gradients (above 20 mm hg); mild paravalvular leak; patient-prosthesis mismatch (two corevalve cases); major or life-threatening bleeding; and major vascular complications.Medtronic transcatheter valves may have been associated with the adverse events.No additional adverse patient effects or product performance issues were reported.

• Brand Name: MEDTRONIC SURGICAL TISSUE VALVE
• Type of Device: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12518705
• MDR Text Key: 272888603
• Report Number: 2025587-2021-02868
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P870078
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MDT-TISSUE VALVE
• Device Catalogue Number: MDT-TISSUE VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2021
• 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: 74 YR