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

Model Number 500FA

Device Problem Insufficient Information (3190)

Patient Problems Atrial Fibrillation (1729); Infarction, Cerebral (1771); Unspecified Infection (1930); Myocardial Infarction (1969); Low Cardiac Output (2501); Blood Loss (2597)

Event Date 02/27/2017

Event Type  Injury  

Manufacturer Narrative

Citation: kurazumi h et al.Outcomes of cardiovascular surgery for chronic dialysis patients in current (b)(6).Asian cardiovasc thorac ann.2019 jul;27(6):464-470.Doi: 10.1177/0218492319859147.Epub 2019 jun 19.Presented at the 47th annual meeting of the japanese society for cardiovascular surgery, tokyo, japan, february 27 to may 1, 2017.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 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 the short- and long-term clinical outcomes for chronic dialysis patients in (b)(6) who underwent cardiovascular surgery.All data were collected from a single center between january 2004 and june 2016.The study population included 70 patients (predominantly male; mean age 67 years), one patient was implanted with a 21 mm medtronic mosaic bioprosthetic valve (aortic position) and 6 were implanted with ats mechanical valves (2 with 16 mm, 3 with 18 mm and 1 with a 20 mm; all in the aortic position).No serial numbers were provided.Among all patients, there were 6 in-hospital deaths and 23 late deaths, respectively.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: post-operative bleeding requiring re-exposure, low cardiac output syndrome requiring ex extracorporeal membrane oxygenation support, cerebral infarction, peri-operative intra-aortic balloon pumping support, peri-operative myocardial infarction, post-operative atrial fibrillation, and mediastinitis.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.

Manufacturer Narrative

Additional information received from the physician/author stated that medtronic product did not cause or contribute to the observed adverse events.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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
• MDR Report Key: 8875203
• MDR Text Key: 153719344
• Report Number: 3008592544-2019-00034
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/24/2019
• Initial Date FDA Received: 08/08/2019
• Supplement Dates Manufacturer Received: 10/09/2019
• Supplement Dates FDA Received: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR