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 Sepsis (2067); Post Operative Wound Infection (2446)

Event Date 09/09/2019

Event Type  Injury  

Manufacturer Narrative

Citation: shah v., et al.Incidence, natural history, and factors associated with paravalvular leak following surgical aortic valve replacement.Innovations (philadelphia, pa.).2019;14(6):519-530.Pmid: 31496371.Doi: 10.1177/1556984519874806.Epub 2019 sep 9.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.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding the incidence and factors associated with paravalvular leak (pvl) after surgical aortic valve replacement (savr).All data were retrospectively collected from a single center between january 2006 and october 2016.The study population included 636 patients (predominantly male, mean age 58.5 years), 18 of whom were implanted with medtronic hancock bioprosthetic valves and 7 of whom were implanted with medtronic ats open pivot mechanical valves (no serial numbers provided).Among all patients, in-hospital mortality was 2% and overall mortality was 21.2%.No further information was provided.Based on the available information medtronic product was not directly associated with the deaths.Among all patients, adverse events included: post-operative wound infections and sepsis.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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10243589
• MDR Text Key: 200226593
• Report Number: 3008592544-2020-00034
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 500FA
• Device Catalogue Number: 500FA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2020
• 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
• Patient Age: 59 YR