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

Model Number CONTEGRA

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

Patient Problems Intimal Dissection (1333); Calcium Deposits/Calcification (1758); Hematoma (1884); Thrombus (2101); Stenosis (2263); Regurgitation, Valvular (2335); Vascular System (Circulation), Impaired (2572)

Event Date 01/16/2019

Event Type  Injury  

Manufacturer Narrative

Citation: ortega-loubon c et al.Late dissection of a contegra conduit: a rare complication.World j pediatr congenit heart surg.2019 mar;10(2):239-241.Doi: 10.1177/2150135118799625.Epub 2019 jan 16.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 a (b)(6)-year-old female patient with a history of truncus arteriosus type 2 initially underwent a procedure to connect the right ventricle and the pulmonary arteries during neonatal age with implant of a 12 mm medtronic contegra valved conduit (serial number not provided).Two years later, the 12 mm conduit was replaced with a 16 mm medtronic contegra valved conduit (serial number not provided) due to somatic growth.Eight years later, an echocardiogram exhibited mild stenosis (gradient noted to be 20 mm hg) of the conduit with moderate regurgitation, however, right ventricular function was reported to be normal.It was stated that at one month following the patient¿s last follow-up appointment, the patient presented with acute symptoms of asthenia, tachypnea, and diaphoresis.An echocardiogram revealed a dilated right ventricle with severe dysfunction and the presence of thrombus (noted to be 3 x 2 cm) in the right ventricular outflow tract.A peak gradient of 68 mm hg was observed while angio-computed tomography confirmed the incidence of a mural thrombus with partial occlusion of the right ventricular outflow tract.Subsequently, the patient underwent emergent surgery due to cardiogenic shock and the contegra conduit was removed and replaced with an 18 mm medtronic hancock valved conduit (serial number not provided).The contegra conduit was reported to have had a ¿large¿ hematoma, an intimal ¿disruption¿ (also identified as a dissection) with intramural thrombus and endothelium calcification.Microscopic examination of the removed conduit also showed ¿thrombotic material with calcifications and foci of neovascularization.¿ no additional adverse patient effects or product performance issues were reported.

• 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 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: 8550731
• MDR Text Key: 143096263
• Report Number: 2025587-2019-01351
• Device Sequence Number: 1
• Product Code: MWH
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 04/25/2019

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: CONTEGRA
• Device Catalogue Number: CONTEGRA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2019
• Initial Date FDA Received: 04/25/2019
• 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: 10 YR