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

Model Number 500FA

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Atrial Fibrillation (1729); Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Sepsis (2067)

Event Date 07/06/2019

Event Type  Injury  

Manufacturer Narrative

Citation: hori d et al.Prosthesis selection for aortic valve replacement in patients on hemodialysis.Gen thorac cardiovasc surg.2 020 feb;68(2):122-128.Doi: 10.1007/s11748-019-01172-w.Epub 2019 jul 6.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 from a literature article regarding the outcomes of patients on hemodialysis who underwent surgical aortic valve replacement.All data were retrospectively collected from a single center between july 2008 to december 2016.The study population included 76 patients and was predominantly male with a mean age of 70 years.Of those, 5 patients were implanted with medtronic mosaic surgical aortic valves and 5 patients were implanted with medtronic ats mechanical aortic valves.No serial numbers were provided.Among all patients, 32 deaths occurred during the follow-up period of approximately 6.7 years.The causes of the deaths included: heart failure, infection, cerebrovascular event, mesenteric ischemia, and unknown cause.Multiple manufacturers devices were implanted in the study population.None of the deaths were directly associated with medtronic product.Among all patients, adverse events included: post-operative stroke, sepsis, need for prolonged ventilation, patient-prosthesis mismatch, atrial fibrillation, bleeding complications, and gastrointestinal complications.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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 10871511
• MDR Text Key: 217465082
• Report Number: 3008592544-2020-00060
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P990046
• 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: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• 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: 10/22/2020
• 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): Life Threatening; Required Intervention
• Patient Age: 70 YR