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

Model Number 500FA

Device Problems Degraded (1153); Perivalvular Leak (1457)

Patient Problems Arrhythmia (1721); Endocarditis (1834); Hemorrhage/Bleeding (1888)

Event Date 12/15/2015

Event Type  Injury  

Manufacturer Narrative

Citation: wang y.Mid- to long-term outcome comparison of the medtronic hancock ii and bi-leaflet mechanical aortic valve replacement in patients younger than 60 years of age: a propensity-matched analysis.Interactive cardiovascular and thoracic surgery 22 (2016) 280¿286.E-published 15 december 2015.Date of e-publish used for event date.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether this event has been previously reported.(b)(4).

Event Description

Medtronic received information via literature review regarding a study which compared clinical outcomes in patients younger than 60 years of age undergoing bioprosthetic versus mechanical aortic valve replacement at one institution from january 2002 to december 2009.The study population included 1,078 patients divided into two groups: 153 patients implanted with a bioprosthetic valve (predominantly male; mean age 52.5 +/- 7.3 years) and 925 patients implanted with a mechanical valve (predominantly male; 48.2 +/- 8.7 respectively).The bioprosthetic valve group received medtronic hancock ii valves exclusively.The mechanical valve group consisted of valves from two manufacturers (an unknown number of which were medtronic ats open pivot bileaflet heart valves).No serial numbers were provided for the devices.Among all patients, 84 deaths occurred (12 bioprosthetic group, 72 mechanical group).The causes of death included: 46 cardiac related, 27 cardiac arrests/myocardial infarction, 6 endocarditis, 6 stroke, 7 hemorrhage/bleeding, 19 non-cardiac related, and 19 unknown.Of these deaths, none were attributed to medtronic product.Among all patients, these adverse events occurred during the 10-year follow up period: 33 thromboembolisms (21 early-term, 12 mid-term), 46 major bleeding events (35 early-term, 11 mid-term), 142 ventricular arrhythmias, 10 paravalvular leak, 10 endocarditis, and 53 multisystem organ failure.There were also 14 valve-related reoperations for the following reasons: 6 structural valve dysfunction, 3 paravalvular leak, 4 endocarditis, and 1 mechanical prosthetic valve deterioration.No additional adverse patient effects were reported.

Manufacturer Narrative

Correction to manufacturer's street address.

Manufacturer Narrative

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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5648999
• MDR Text Key: 44983033
• Report Number: 2025587-2016-00706
• 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,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 05/11/2016
• Was Device Evaluated by Manufacturer?: No
• 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: 48 YR