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

Model Number CONTEGRA

Device Problem Calcified (1077)

Patient Problems Ossification (1428); Calcium Deposits/Calcification (1758); Pulmonary Valve Stenosis (2024)

Event Date 01/01/2005

Event Type  Injury  

Manufacturer Narrative

Citation: boethig d et al.Mid term course after pediatric right ventricular outflow tract reconstruction: a comparison of homografts, porcine xenografts and contegras.European journal of cardio-thoracic surgery.2005; (27) 58¿66.Doi:10.1016/j.Ejcts.2004.09.009.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 explants and reoperation rates between different devices used to reconstruct the right ventricular outflow tract (rvot).All data were collected from a single center between april 1991 and january 2003.The study population included 190 patients (predominantly female; mean age 4.3 years), 109 of which were implanted with a medtronic contegra conduit (serial numbers were not provided).Among all contegra patients, there was an observed hospital mortality rate of 7.4% (below the expected rate of 10.2%).None of the deaths were attributed to medtronic product.Among all patients observed adverse events included: pulmonary artery stenosis, ossification, calcification, and reoperations including explant of the conduit.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: 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: 6584690
• MDR Text Key: 75761406
• Report Number: 2025587-2017-00846
• Device Sequence Number: 1
• Product Code: MWH
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/25/2017

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: 04/25/2017
• Initial Date FDA Received: 05/23/2017
• Supplement Dates Manufacturer Received: 04/25/2017
• Supplement Dates FDA Received: 10/04/2017
• 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: 56 MO