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

Model Number CONTEGRA

Device Problems Calcified (1077); Gradient Increase (1270)

Patient Problems Calcium Deposits/Calcification (1758); High Blood Pressure/ Hypertension (1908); Pulmonary Valve Stenosis (2024)

Event Date 12/07/2016

Event Type  Injury  

Manufacturer Narrative

Citation: falchetti et al.Contegra 12 mm: how long can it last - world j pediatr congenit heart surg.E-published (b)(6) 2016 earliest date of publish used for event date.(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 a (b)(6) year old female with a medical history of type 1 truncus arteriosus, large ventricular septal defect, right ventricular hypertrophy, and truncal valve regurgitation who underwent implant of a medtronic (b)(4) (serial number not provided) before 1 year of age.Postoperative pulmonary hypertension was reported at the time of surgery and the patient was discharged home.At the age of (b)(6) years, the patient presented with conduit stenosis and increased gradients as shown via transthoracic echocardiography.Mild shrinkage of the conduit and moderate peripheral calcification was revealed on computed tomography (ct).The patient underwent successful explant and replacement of the with another unspecified conduit.The recovery was uneventful and the patient was discharged home 16 days postoperative.Evaluation of the explanted conduit found fibrin spots in occasional nodules, peripheral calcifications, and moderate infiltration of multinucleated cells with the leaflets intact.No further patient adverse effects were reported.

Event Description

Additional information received from the physician/author provided: a statement that the conduit performed much longer than expected, and (b)(6).

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: 6244285
• MDR Text Key: 64578831
• Report Number: 2025587-2017-00079
• Device Sequence Number: 1
• Product Code: MWH
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 03/06/2017

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: 12/15/2016
• Initial Date FDA Received: 01/11/2017
• Supplement Dates Manufacturer Received: Not provided; 03/06/2017
• Supplement Dates FDA Received: 03/09/2017; 09/28/2017
• 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: 16 YR
• Patient Weight: 3