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

Model Number 500DM

Device Problems Calcified (1077); Gradient Increase (1270); Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583); Obstruction of Flow (2423)

Patient Problems Calcium Deposits/Calcification (1758); Mitral Regurgitation (1964); Mitral Valve Stenosis (1965); Regurgitation (2259); Vascular System (Circulation), Impaired (2572)

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

Citation: house cm et al.Prevalence and doppler echocardiographic characteristics of normally functioning mitral prostheses with mean gradient = 10 mmhg.J heart valve dis.2017 nov; 26 (6): 667-676.No doi available.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 the return of the product, no definitive conclusion can be made regarding the clinical observations.Additional patient and device codes: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding the prevalence of normally functioning mitral prostheses with mean gradient greater than or equal to 10 mmhg, and to identify the characteristics and echocardiographic variables to distinguish normal function from dysfunction.All data were collected from an unspecified number of centers between december 2009 and september 2016.The study population included a total of 62 patients (predominantly female; mean age 58.8 years), 5 of which were implanted with a medtronic mosaic bioprosthetic valve (one 25 mm, one 27 mm, two 29 mm, and one 31 mm), and 3 were implanted with a medtronic ats open pivot mechanical valve (one 27 mm, one 29 mm, and one 33 mm).No serial numbers were provided.Among all patients, 3 deaths occurred.Based on the available information, medtronic product did not cause or contribute to these deaths.Among all patients, adverse events included: repeat mitral valve replacement, valve-in-valve mitral replacement, prosthesis-patient mismatch, obstruction, valvular or perivalvular insufficiency, significant perivalvular leak, mitral stenosis (annular calcification), mitral regurgitation, and high mean gradients.Multiple manufacturers were noted in the literature; based on the available information a direct correlation could not be made between medtronic product and the observed adverse events.No additional adverse patient effects or product performance issues were reported.

• Brand Name: OPEN PIVOT AP MITRAL 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: 7965646
• MDR Text Key: 123715238
• Report Number: 3008592544-2018-00045
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 500DM
• Device Catalogue Number: 500DM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2018
• 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): Required Intervention
• Patient Age: 58 YR