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

Model Number PVC214

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Occlusion (1984); Respiratory Distress (2045)

Event Date 12/22/2016

Event Type  Death  

Manufacturer Narrative

Additional information has been requested, but no new information has been received to date.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.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 that on the day of implant of this pulmonary bioprosthetic valved conduit, the device blocked the patient's pulmonary veins.Subsequently, the patient died.No other adverse patient effects were reported.

Manufacturer Narrative

Additional information received from the physician indicated that the patient had a conduit replacement due to trachea compression by a conduit aneurysm.Three days post-implant, the patient died of sepsis and multi organ failure.There was no pulmonary vein blockage.Conclusion: the patient's medical history includes truncus arteriosus and a prior rastelli type procedure.Neither autopsy nor explant information was reported.With the limited information available, a relationship between the device and the reported death could not be established.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.

Manufacturer Narrative

Medtronic obtained additional clarifying information from the physician that 14 days post implant of this 14mm pulmonary valved conduit, the patient presented with a high mean airway pressure.The physician suspected tracheal compression.No ct image was performed to confirm tracheal compression.The physician made the decision to replace the pulmonary valved conduit with a 12mm pulmonary valved conduit.Post-operative follow-up showed no dilatation on the second conduit.Six day post implant of the second pulmonary valved conduit the patient passed away due to pneumonia and sepsis.The physician stated the patient¿s death was not related to any medtronic device.Updated medical history noted type ii truncus arteriosus with no pulmonary trunk and a prior rastelli type procedure.The patient date of death should be correct to state (b)(6) 2016.Updated the model and serial number updated.The implant date updated.The explant date updated.(b)(4).The dhr review was performed, there were no correlations / issues identified regarding manufacturing.The device was manufactured per approved and released manufacturing processes and the device met all applicable manufacturing specifications prior to release for distribution.Conduit dilatation is a known failure mode of non supported contegra.At this time, a true cause could not be identified without the return of the device.Combination of patient anatomy, co-morbidities and procedure may have contributed to the product event.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.

• Brand Name: VALVE CONDUIT 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: 6313110
• MDR Text Key: 66858861
• Report Number: 2025587-2017-00216
• Device Sequence Number: 1
• Product Code: MWH
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: H020003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2020
• Device Model Number: PVC214
• Device Catalogue Number: PVC214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/02/2017
• Date Device Manufactured: 08/02/2016
• 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): Death; Required Intervention
• Patient Age: 25 DA