VALIANT THORACIC

Report

Report Number: 2953200-2013-00658
Event Type: Injury
Date Received: April 11, 2013
Date of Event: July 15, 2009
Report Date: March 15, 2013
Manufacturer: MEDTRONIC CARDIOVASCULAR SANTA ROSA
Product Code: MIH
PMA / PMN Number: P100040
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). RESULTS: ENDOLEAK. TYPE V ENDOLEAK. CONCLUSION: TYPE V ENDOLEAK.

Description of Event or Problem · 1

ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PREVIOUSLY REPORTED TYPE V ENDOLEAK RESOLVED WITHOUT TREATMENT. THE PHYSICIAN ASSESSED THIS EVENT AS NOT PROCEDURE RELATED. THE DEVICE RELATION REMAINS UNKNOWN.

Description of Event or Problem · 1

A VALIANT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM APPROXIMATELY 45 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT TWO YEARS POST IMPLANT, A TYPE V ENDOLEAK WAS IDENTIFIED AND NO INTERVENTION WAS PERFORMED. THE INVESTIGATOR ASSESSED THIS EVENT AS NOT PROCEDURE RELATED AND DEVICE RELATIONSHIP WAS NOT REPORTED. ADDITIONAL INFORMATION WAS RECEIVED RECENTLY WHERE IT WAS REPORTED THAT THE ANEURYSM DIAMETER INCREASED 10 MM OVER A 12 MONTH PERIOD AND THIS WAS DUE TO THE TYPE V ENDOLEAK WHICH WAS PREVIOUSLY REPORTED. THE ANEURYSM EXPANSION WAS IN ZONE 3 AND 4 OF THE THORACIC AORTA. THE DEVICE AND PROCEDURE RELATION ARE UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. PLEASE NOTE THAT THIS MODEL NUMBER TF3636C150XC IS NOT APPROVED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE VAMF3636C150TE WHICH IS APPROVED IN THE UNITED STATES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
155693	VALIANT THORACIC	SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	MEDTRONIC CARDIOVASCULAR SANTA ROSA		V00285424

Patients

Seq	Age	Sex	Outcome	Treatment
1	00061 YR