MAUDE Adverse Event Report: HEART VALVES SANTA ANA CONTEGRA PULMONARY VALVED CONDUIT - SUPPORTED; CONDUIT,VALVED,PULMONIC

Model Number 200S

Device Problems Calcified (1077); Gradient Increase (1270); Stretched (1601); Torn Material (3024)

Patient Problems Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Pulmonary Valve Stenosis (2024); No Code Available (3191)

Event Date 02/01/2007

Event Type  Injury  

Manufacturer Narrative

Dilation, pannus and calcification are known adverse events.A root cause to these clinical observations could not be determined from the available information.Pannus and calcification are generally patient- related conditions.Without the serial number of the product no device history could be pulled and reviewed.

Event Description

Medtronic received information from a journal article that a 14 mm pulmonary valved conduit was replaced five years after its implant due to observation of an aneurysm by echocardiography, angiography, and magnetic resonance tomography.The device had been implanted in the patient at 13 months of age.The issue was identified when a routine chest roentgenogram showed a right ventricular dilatation.Subsequent investigation showed enlargement of the right ventricle, a progressive increase of right ventricular pressure and stenosis at the supravalvular area with increased gradients.Post-explant findings included collagenization, mild foreign body reaction, pannus formation, extensive mineralization, and a torn leaflet.The patient underwent conduit replacement with a 15-mm homograft.No subsequent adverse patient effects were reported.The authors noted that aneurysmal dilatation of this model device had rarely been reported and usually was explained with increased pressure in the right ventricle, and that for this patient, proximal as well as distal aneurysmal dilatation of the conduit was observed, presumably as a result of the stenosis of the distal anastomosis caused by pannus formation and increasing stress of the wall of the conduit.

Manufacturer Narrative

A review of medtronic's data bases showed that there had been no previous complaints or returned devices for this model family from this health care facility.(b)(4).

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: CONTEGRA PULMONARY VALVED CONDUIT - SUPPORTED
• Type of Device: CONDUIT,VALVED,PULMONIC
• Manufacturer (Section D): HEART VALVES SANTA ANA; 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: 4752943
• MDR Text Key: 13280420
• Report Number: 2025587-2015-00517
• 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,Literature,Health Professional,foreign,health profe
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/28/2015

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: 05/28/2015
• Initial Date FDA Received: 05/06/2015
• Supplement Dates Manufacturer Received: Not provided; 05/28/2015
• Supplement Dates FDA Received: 06/01/2015; 09/18/2017
• 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): Required Intervention
• Patient Age: 00006 YR