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); Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Heart Failure/Congestive Heart Failure (4446)

Event Date 08/01/2021

Event Type  Injury  

Manufacturer Narrative

Citation: liang y, et al.A single-center analysis of outcomes, risk factors, and new valves in asian patients treated with early tr anscatheter aortic valve implantation.Cardiovasc diagn ther.2021 aug;11(4):967-979.Doi: 10.21037/cdt-20-928.Earliest date of publish used for date of event: (b)(6) 2021 (month and year valid).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 patient outcomes following transcatheter aortic valve implantation (tavi) compared with those of surgical aortic valve replacement (savr).All data was retrospectively collected from a single center between (b)(6) 2012 and (b)(6) 2018.In the savr group (109 patients; predominantly male; mean age (b)(6) years), an undisclosed number of patients were implanted with a medtronic bioprosthetic (hancock ii and mosaic) or mechanical (open pivot) valve.No unique device identifier numbers were provided.In the savr group, the 1-year and 3-year all-cause mortality included 2 and 4 patients, respectively.No statement was made suggesting a causal or contributory relationship between medtronic product and the deaths.In the savr group, post-operative adverse events included: stroke, permanent pacemaker implantation, high-grade atrioventricular block, atrial fibrillation, heart failure, unspecified major vascular complication, and hospital readmission.Medtronic product may have been associated with the adverse events.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Updated information: a4.Mean weight of the savr group provided by the physician/author.B5.Additional information received from the physician/author stated that 40 of the 109 patients in the savr group were implanted with a medtronic valve: hancock ii (n = 25), mosaic (n = 11), and open pivot (n = 4).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
• 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: 13212690
• MDR Text Key: 288284557
• Report Number: 3008592544-2022-00001
• 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,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• 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: 01/24/2022
• 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; Life Threatening; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 66 KG