MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION AVALUS AORTIC TISSUE VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 40017

Device Problems Partial Blockage (1065); Degraded (1153); Perivalvular Leak (1457)

Patient Problems Aortic Regurgitation (1716); Endocarditis (1834); Insufficiency, Valvular (1926); Vascular System (Circulation), Impaired (2572)

Event Date 01/30/2020

Event Type  Injury  

Manufacturer Narrative

Citation: faure m., et al.Surgically implanted aortic valve bioprostheses deform after implantation: insights from computed tomography.Eur radiol, 30 jan 2020; https://doi.Org/10.1007/s00330-019-06634-6 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 use of multi-detector row computerized tomography (mdct) to determine the prevalence and degree of aortic bioprosthetic valve deformation.All data were retrospectively collected from multiple centers between 2007 and 2019.The study population included 152 patients (demographics not provided), eight of whom were implanted with medtronic mosaic bioprosthetic valves (no serial numbers provided) and one implanted with a medtronic avalus bioprosthetic valve (no serial numbers provided).Among all patients adverse events included: suspected endocarditis, suspected aortic regurgitation, suspected obstruction, and suspected bioprosthetic valve dysfunction requiring intervention.Based on the available information medtronic product may have been associated with the adverse events.Among all patients malfunctions included: bioprosthetic valve geometrical deformation/eccentricity.Based on the available information medtronic product may have been associated with the malfunctions.No additional adverse patient effects or product performance issues were reported.

• Brand Name: AVALUS AORTIC TISSUE VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9838923
• MDR Text Key: 191376558
• Report Number: 2025587-2020-00794
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P990064
• 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
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 40017
• Device Catalogue Number: 40017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention