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

Model Number 500FA

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Regurgitation (2259)

Event Date 09/21/2017

Event Type  Injury  

Manufacturer Narrative

Citation: suh yj et al.A whole-heart motion-correction algorithm: effects on ct image quality and diagnostic accuracy of mechanical valve prosthesis abnormalities.J cardiovasc comput tomogr.2017 nov;11(6):474-481.Doi: 10.1016/j.Jcct.2017.09.011.Epub 2017 sep 21.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.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding the effect of a new motion correction algorithm prototype called new generation snapshot freeze (ng ssf) on the image quality of cardiac computed tomography in patients with mechanical valve prostheses by comparison with standard images without motion correction and evaluated the diagnostic accuracy of ng ssf images for detection of prosthetic valve abnormalities.All data were collected from a single center between december 2016 and january 2017.The study population included 20 patients (predominantly female; mean age 56.8 ± 14.3 years), 3 of which were implanted with a medtronic open pivot mechanical heart valve (1 aortic implant and 2 mitral implants).No serial numbers were provided.Among all patients, adverse events included: redo-cardiac surgery, subprosthetic pannus and paravalvular leak.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 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: 7940130
• MDR Text Key: 123041575
• Report Number: 3008592544-2018-00043
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• 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: 09/24/2018
• 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: 56 YR