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

Model Number 500DM

Device Problem Perivalvular Leak (1457)

Patient Problems Stroke/CVA (1770); Congestive Heart Failure (1783); Mitral Regurgitation (1964); Myocardial Infarction (1969); Low Cardiac Output (2501); Blood Loss (2597)

Event Date 03/23/2018

Event Type  Injury  

Manufacturer Narrative

Citation: li b et al.Long-term outcomes of mitral valve annuloplasty versus subvalvular sparing replacement for severe ischemic mitral regurgitation.Cardiol j.2019;26(3):265-274.Doi: 10.5603/cj.A2018.0006.Epub 2018 mar 23.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 evaluation of the long-term outcomes in patients with severe chronic ischemic mitral regurgitation who underwent mitral valve annuloplasty (mva) or subvalvular sparing mitral valve replacement (mvr).All data were retrospectively collected from a single center between january 2003 and december 2014.The study population included 392 patients (predominantly male; mean age 61 years), an unspecified number of which were implanted with medtronic duran ancore annuloplasty rings, medtronic mosaic bioprosthetic valves, medtronic hancock ii bioprosthetic valves, or medtronic open pivot mechanical valves.No serial numbers were provided.Among all patients, 62 deaths occurred during follow-up (median follow-up of 53 months).Of those, 53 were due to cardiac causes.No other details were reported.Multiple manufacturers were noted in the literature; based on the available information, medtronic product was not directly associated with the deaths.Among all patients, adverse events included: reoperation for bleeding, post-operative intra-aortic balloon pump support, moderate mitral regurgitation (mva and mvr patients), severe mitral regurgitation (mva patients), periprosthetic leak (mvr patients), and decreased left ventricular ejection fraction.It was also noted that 82 mva patients and 14 mvr patients experienced macce (major adverse cardiac and cerebrovascular event) during long-term follow-up.Macce included: repeat revascularization and myocardial infarction, stroke, subsequent mitral valve surgery, or hospitalization for heart failure.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 AP MITRAL 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: 8975788
• MDR Text Key: 156954487
• Report Number: 3008592544-2019-00043
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 500DM
• Device Catalogue Number: 500DM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2019
• 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: 61 YR