• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

HEART VALVES SANTA ANA CONTEGRA PULMONARY VALVED CONDUIT - SUPPORTED; CONDUIT,VALVED,PULMONIC Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key4752943
MDR Text Key13280420
Report Number2025587-2015-00517
Device Sequence Number1
Product Code MWH
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
H020003
Number of Events Reported1
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 Number200S
Device Catalogue Number200S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/28/2015
Initial Date FDA Received05/06/2015
Supplement Dates Manufacturer ReceivedNot provided
05/28/2015
Supplement Dates FDA Received06/01/2015
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 Number1
Patient Outcome(s) Required Intervention;
Patient Age00006 YR
-
-