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

Model Number 200H12

Device Problems Calcified (1077); Material Distortion (2977)

Patient Problems Calcium Deposits/Calcification (1758); Death (1802); Endocarditis (1834); Pulmonary Regurgitation (2023); Thrombus (2101); Stenosis (2263)

Event Date 08/01/2009

Event Type  Death  

Manufacturer Narrative

(b)(4).Title: european contegra multicentre study: 7-year results after 165 valved bovine jugular vein graft implantations citation: thorac cardiovasc surg.2009 aug;57(5):257-69.Authors: t.Breymann, u.Blanz, m.A.Wojtalik,w.Daenen, r.Hetzer, g.Sarris, g.Stellin, c.Planche, v.Tsang, n.Weissmann, d.Boethig month and year of publish used for event date.Death date(s) unknown; event date used for death date.No unique device identifier (serial/lot) numbers were provided; without this information it cannot be determined whether this event has been previously reported.

Event Description

Medtronic received information via literature review that a study was performed to evaluate the seven year results of 165 contegra valved bovine jugular vein graft implantations.The study population included 165 patients implanted with a contegra valved conduit (serial numbers not provided), predominantly male with a mean age of 3.9 years.Among all patients, 23 deaths occurred, which included: 12 patients died from (unspecified) heart failure or low cardiac output, 3 from right heart failure (one of them after injury of the right coronary artery).The causes of death of the other patients were aortic valve incompetence, a pulmonary hypertensive crisis, pneumonia, aneurysm at the proximal conduit anastomosis, sepsis, pulmonary bleeding, cerebral oedema and sudden death.18 of the 23 patients died in the first postoperative month, the other 5 within the first year.Expected versus observed mortality: according to the rachs-1 risk classification, the hospital death of 19 patients was to be expected for the study population.Of these deaths, two were associated with medtronic products.One was a patient with heart failure, whose moderate conduit insufficiency contributed to exhausting the already damaged ventricle; the other patient had an aneurysm at the proximal conduit anastomosis.Among all patients, 137 adverse events occurred, which included: 5 endocarditis, 21 stenosis, 58 cases of catheter-based interventions, 7 calcification, 1 dilatation, 45 insufficiency.Among the adverse events there were 27 explantation noted at the end of the observation phase, corresponding to a 74.0 +- 0.5% freedom from explantation at 7 years.Stenoses of the peripheral pulmonary arteries were the reason for the explantation of 10 contegras (37.0% of all explanted ones) after 2.6 +- 0.6 years.Technical reasons (accidental valve cusp stenting, conduit distortion, muscular rvot stenosis, aneurysm of the right ventricular outflow tract, access facilitation to a stenotic pulmonary artery branch) accounted for other 5 explants (18.5%) after 5.11 +- 0.9 years.5 contegras (18.5%) were explanted for endocarditis after 4.1+- 0.7 years, 3 (11.1%) were explanted for valvular degeneration after 4.2 +- 0.8 years, 2 (7.4%) for thrombus formation after 0.6 ᠰ.8 years, and 1 for dilatation at 2.6 years; 1 contegra which was still working well was explanted for outgrowth at 5 years after implantation.

Event Description

Additional information from the physician/author provided device identifier numbers for 165 patients that were not legitimate serial numbers; therefore this data could not be used to verify whether any of these adverse events had been previously reported to the company.In addition, the physician/author stated that while a death could possibly at the very least be partially be due to the device, there were no deaths due to an acute failure of the contegra valved conduit, and that the explanted devices were no longer available.

Manufacturer Narrative

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.

• Brand Name: 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 STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5339724
• MDR Text Key: 34882746
• Report Number: 2025587-2016-00001
• 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,Followup
• Report Date: 01/15/2016

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 200H12
• Device Catalogue Number: 200H12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2015
• Initial Date FDA Received: 01/02/2016
• Supplement Dates Manufacturer Received: Not provided; 01/15/2016
• Supplement Dates FDA Received: 01/21/2016; 09/19/2017
• 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): Death; Required Intervention
• Patient Age: 00004 YR