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

Model Number 200S

Device Problems Calcified (1077); Gradient Increase (1270); Obstruction of Flow (2423)

Patient Problems Endocarditis (1834); Foreign Body Reaction (1868); Pulmonary Valve Stenosis (2024); Fibrosis (3167)

Event Date 01/20/2011

Event Type  Injury  

Manufacturer Narrative

Citation: schoenhoff fs et al.The contegra bovine jugular vein graft versus the shelhigh pulmonic porcine graft for reconstruction of the right ventricular outflow tract: a comparative study.J thorac cardiovasc surg.2011 mar;141(3):654-61.Doi: 10.1016/j.Jtcvs.2010.06.068.Epub 2011 jan 20.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 the return of the product, no definitive conclusion can be made regarding the clinical observations.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding an evaluation of the contegra bovine jugular vein graft and the shelhigh pulmonic xenograft for right ventricular outflow tract (rvot) reconstruction and an examination of the impact of known risk factors for premature graft failure.All data were collected from a single center between december 1999 and september 2008.The study population included 84 patients (mean age 12 years), 43 medtronic contegra valved conduits were implanted (no serial numbers provided).It was noted that these procedures were performed by using all levels of extracorporeal support from deep hypothermic circulatory arrest to moderate hypothermia and beating heart surgery.Among all contegra patients, 3 deaths occurred due to: acute right heart failure during anesthesia induction (1 case), unsuccessful weaning from post-cardiotomy extracorporeal membrane oxygenation support (1 case), and severe respiratory failure (1 case).Based on the available information, medtronic product was not directly associated with the deaths.Among all patients, adverse events included: conduit replacement due to stenosis, unsuccessful balloon dilatation of the conduit leading to reoperation, suspected endocarditis requiring conduit replacement, and high right ventricle¿pulmonary artery pressure gradients.It was reported that explanted conduits underwent histological examination that revealed ¿a chronic inflammation with foreign body reaction and lymphocyte infiltration¿ and focal microcalcifications within the conduit walls.In particular, the explanted contegra conduits exhibited deposition of fibrous tissue and fibrotic membrane formation around the distal anastomotic site.Based on the available information, medtronic product was directly associated with the adverse events.No additional adverse patient effects or product performance issues were reported.

• Brand Name: CONTEGRA PULMONARY VALVED CONDUIT
• 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: 8902040
• MDR Text Key: 154608427
• Report Number: 2025587-2019-02598
• Device Sequence Number: 1
• Product Code: MWH
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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
• Report Date: 08/16/2019

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: 200S
• Device Catalogue Number: 200S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/05/2019
• Initial Date FDA Received: 08/16/2019
• 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: 12 YR