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

Model Number 30525

Device Problem Insufficient Information (3190)

Patient Problems Congestive Heart Failure (1783); Non specific EKG/ECG Changes (1817); Pneumonia (2011); Renal Failure (2041); Sepsis (2067); Tricuspid Regurgitation (2112); Tricuspid Valve Stenosis (2113); Blood Loss (2597)

Event Date 03/16/2016

Event Type  Injury  

Manufacturer Narrative

Citation:david r.Koolbergen,md article title.Follow-up after tricuspid valve surgery in adult patients with systemic right ventricles journal title: european journal of cardio-thoracic surgery 2016, 50: 456¿463 10.1093/ejcts/ezw059 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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding the evaluation of mid-term functional improvements, echocardiographic findings and survival after tricuspid valve (tv) surgery in patients with congenitally corrected transposition of the great arteries (cctga) or after atrial (mustard or senning) correction for transposition of the great arteries (actga), the right ventricle (rv) supports the systemic circulation.All data were collected from multiple centers between july 1999 to november 2014.The study population included 26 patients (predominantly female, mean age 37 years, 1 of which was implanted with medtronic mosaic (serial numbers not provided).Among all patients adverse events included: arrhythmias, renal insufficiency, re-operation, bleeding, tricuspid stenosis, tricuspid regurgitation, sepsis, pneumonia and congestive heart failure (chf).Multiple manufacturers were noted in the literature; based on the available information a direct correlation could not be made between the observed adverse events and a medtronic product.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: MOSAIC AORTIC BIOPROSTHETIC HEART 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: 6686382
• MDR Text Key: 79059791
• Report Number: 2025587-2017-01092
• 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,Followup
• Report Date: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 30525
• Device Catalogue Number: 30525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2017
• 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): Required Intervention
• Patient Age: 37 YR