MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION VALVE CONTEGRA; CONDUIT,VALVED,PULMONIC

Model Number CONTEGRA

Device Problem Calcified (1077)

Patient Problems Ossification (1428); Autoimmune Reaction (1733); Stenosis (2263)

Event Date 01/01/2012

Event Type  Injury  

Manufacturer Narrative

Citation: holmes a et al.The contegra conduit: late outcomes in right ventricular outflow tract reconstruction.Ann pediatr cardiol.2012 jan-jun; 5(1): 27¿33.Doi: 10.4103/0974-2069.93706 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.(b)(4).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 clinical outcomes and performance of the contegra conduit as a right ventricle outflow tract implant.All data were collected from a single center between january 2002 and june 2009.The study population included 45 patients (predominantly male; mean age 4 years) all which were implanted with a medtronic contegra conduit (serial numbers not provided).Among all patients 3 deaths occurred; none of the deaths were attributed to medtronic product.Among all patients there were 9 conduit related surgical interventions (5 due to conduit stenosis and 4 due to distal stenosis).Of 8 conduit explants, all eight were found to have partially or fully calcified valve leaflets and fibrotic tissue in the supravalvular region, all eight had evidence of epithelioid giant cell immune response to foreign bodies, and three were noted with sites of ossification.No additional adverse patient effects were reported.

Manufacturer Narrative

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

• Brand Name: VALVE CONTEGRA
• Type of Device: CONDUIT,VALVED,PULMONIC
• 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: 6439797
• MDR Text Key: 71039442
• Report Number: 2025587-2017-00495
• Device Sequence Number: 1
• Product Code: MWH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: H020003
• 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: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CONTEGRA
• Device Catalogue Number: CONTEGRA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2017
• Initial Date FDA Received: 03/28/2017
• Supplement Dates Manufacturer Received: 02/27/2017
• Supplement Dates FDA Received: 10/02/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR