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

Model Number 500DM

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Endocarditis (1834); Mitral Valve Stenosis (1965); Thrombosis/Thrombus (4440); Heart Block (4444); Heart Failure/Congestive Heart Failure (4446)

Event Date 07/30/2021

Event Type  Injury  

Manufacturer Narrative

Citation: brancaccio et al.Predictors of survival in paediatric mitral valve replacement.Eur j cardiothorac surg.2021 jul 30;60(2):361-366.Doi: 10.1093/ejcts/ezab078.Earliest date of publish used for date of event.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 predictors of survival in pediatric mitral valve replacement.All data were collected retrospectively from a single center between july 1, 1982 and december 31, 2019.The study population included 115 patients (predominantly female, median age 5.5 years, mean weight 15 kg).Multiple manufacturer¿s devices were implanted in the study population.Among all patients 36 were implanted with a medtronic melody (n=2), hancock ii (n=16), hancock conduit (n=7), or an ats mechanical valve (n=11).No unique device identifier numbers were provided.Among all patients, there were 11 early and 13 late deaths.Causes of death included myocardial infarction (mi), acute thrombosis, multi-organ failure, cerebral hemorrhage, congestive heart failure (chf) and sudden death.Based on the available information medtronic product was not directly associated with the death(s).Among all patients, adverse events included: stenosis, unspecified dysfunction, thrombosis, unspecified degeneration, endocarditis, complete heart block requiring permanent pacemaker implant, stroke, and congestive heart failure (chf).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 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12749324
• MDR Text Key: 280062875
• Report Number: 3008592544-2021-00041
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• 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: 10/20/2021
• 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): Congenital Anomaly; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 66 MO
• Patient Weight: 15